Exploring the practical wisdom of mētis for management learning

This article investigates the nature of practical wisdom in organizational life through the notion of mētis, which we interpret as situated resourcefulness. Drawing on Greek mythology, we explore the nature of mētis and discuss its mythological characteristics in relation to a contemporary organizational episode. We suggest that the consideration of mētis not only highlights the shortcomings of measurement and conceptual order in management, but also allows us to project a more processual managerial response which accepts the fallacy of unilateral control and strives towards a harmonic balance of continually unfolding, dynamic and recursive patterns.

Introduction
Organizational scholars frequently remind us that the objects we study are not naturally given, but the products of human abstractions (e.g. Cooper, 2005;Taylor, 2011;Willmott, 2011). Concepts such as institutions, organizations, agents, or routines belong to a 'metalanguage' that give form to the world and thus make it thinkable and our understandings generalizable (Cooper, 1986). Concept-based rationalities afford a grip on an otherwise formless and fluid world and it comes as no surprise that, as Langley et al.(2002: 355) find, such approaches thrive in contexts of unclear goals and uncertainty, as "individuals use them in attempts to inform, persuade, control or impress others". However, the metalanguage of concepts not only works on an individual level but also as an organizational force that applies and extends 'power, domination, command and influence' (Barker, 2005: 788). Once objectified, even seemingly disparate domains, for instance those of governmental activities and business planning, can be made compatible and managed (see Townley: 2004: 439). Establishing apparent common denominators, for instance, first affords the measurement of 'value for money ', or 'verifiable' and 'auditable' processes (Power, 1996), as well as 'enterprising' activity (Doolin, 2002) in New Public Government; or product and service quality ', 'customers', 'costs', and 'value' in the context of Non-Governmental Organizations work on human aid (Everett and Friesen, 2010: 476).
Yet, the more general and abstract these concepts become, the more likely they are to also generate complexities, ambiguities, and paradoxes for academics and practitioners alike (Sayer, 1992). As March (2006: 208) notes, rational calculations "depend on strong assumptions about the extent to which present knowledge encompasses the causal structure of the world and the preference structures of humans". In such abstractions however, even "small errors or oversights multiply into large ones and multiply at an increasing rate as complexity increases" (ibid: 208)., Jane Jacobs (1993), for example, provides detailed accounts of instances in which urban planning efforts intended to improve built environments actually contributed to the dysfunction of many modern cities. These include the establishment of traffic schemes where the anticipated primary purpose of streets is to efficiently transport vehicles from A to B. However, while the stipulation of such singular purposes may afford more efficient traffic flows, it ignores the various additional roles a street plays in the lives of residents, for instance as a place to mingle and watch out for one another. In reducing the diverse uses of a street to singular, measurable and manageable ends, such schemes may thus result in inhospitable multi-lane highway complexes that cut through cities and thereby foster anonymity, hamper the development of community ties, and increase the perception of criminal threat.
It is therefore not surprising that measurement efforts, even when taken up enthusiastically as 'more rational' attempts at benefitting the 'public interest' (e.g. Townley et al., 2003), tend to be fraught with difficulties (e.g. Mintzberg, 1994).
These difficulties emerge when concepts and the classificatory systems afforded by simplified abstractions and measurements run up against the 'radical contingency of the future' (Scott, 1998: 343). Measurements therefore hold little absolute value, as in practice, most measurement results need to be interpreted in line with situational demands (Tsoukas & Hatch, 2001;Weick, 1985). Yet precisely such interpretations are difficult to make, as the "tacit knowledge, judgment, and the practical experience of the performer [which] are all necessary to the performance … are also extremely difficult if not impossible to capture through words and numbers" (Everett and Friesen, 2010: 476). Moreover, the very act of measuring can lead to changes in the world, for instance when those subjected to such surveillance react and adjust their actions to fit with bureaucratic demands (Scott, 1998: 247). It therefore seems that concepts alone cannot establish or capture practice. The act of abstraction deprives concepts of what Wittgenstein calls 'significance'; their situatedness in a totality of ordinarily intelligible surroundings (Wittgenstein, 1967: §17;1998: §583). This means that any seemingly rogue object, such as an empty breadbox outside a grocery shop, can come to serve as a meeting point or a landmark (Jacobs, 1993: 90;488) and thus add to the vibrancy and safety of a healthy, living city without serving any planned purpose. Yet, crucially, the meaning of such entities is only disclosed at the level of the pedestrian, often without displaying any surface regularity.
While some, like Grey (2012: 9), take this as an invitation to invoke a range of organizational theories "regardless of what camp or perspective they come from and regardless of their current fashionability"; the majority of work seems to accept the impotence of abstract concepts. As Feibleman (1944: 117) observes, the more scientific the achievements in an academic field become, the more the field removes itself from 'common sense' and the less useful its concepts seem to become outside the domain of conceptual logics.
There have however been efforts to recover common sense in addition to conceptual logics when studying organizations; with this effort arises the possibility of a different kind of social research. Chia and Holt (2009: 105), for example, invoke the Aristotelian virtue 'phronesis' to emphasize that managerial work requires "integrative wisdom acquired from experience and immersion in practice" to cope with the inherent incompleteness of formalized knowledge. In this paper we investigate a further particular kind of practical wisdom referred to as 'mētis' -"a way of knowing" which "implies a complex but very coherent body of mental attitudes and intellectual behavior which combine flair, wisdom, forethought, subtlety of mind, deception, resourcefulness, vigilance, opportunism, various skills, and experience acquired over the years" (Detienne and Vernant, 1978: 3-4).
Mētis is frequently translated as 'cunning', and thus brings connotations of deviousness and obliqueness. However, this usage is limiting as in the literature examples of mētis include the skill of the sailor or farmer in reading and responding to the formidable forces of nature; the flair of the politician in spinning arguments; the experienced diagnostic glance of the doctor and, more generally, the instinctual, subtle and learned application of a craft (techné) in a situated response to unfolding circumstances (Klein, 1986;Detienne and Vernant, 1978). Importantly, mētis is also portrayed as a form of resistance to measurement and control systems (de Certeau, 1988;Scott, 1998). Mētis has been discussed in some sociological texts, but only infrequently in the context of organizational literature (e.g. Toulmin, 2001;Latiche and Statler, 2005). This is surprising, given the commonplace association of organizational processes and managerial work with cleverness and tricks (Collin et al., 2011), intrigue, manipulation and political agendas (Tosey, 1989), or the skillful navigation of formal structures (Corbett-Etchevers and Mounoud, 2011).
In this paper we investigate mētis in the context of management learning. We approach this form of knowledge by attempting a differentiation with phronesis, before discussing examples in the management learning literature. We then turn to Greek mythology as a basis for an empirical exemplification of mētic maneuvers in a contemporary organization.

Mētis in management learning
Much orthodox organizational research highlights the importance of understanding the world in terms of objective and transparent information structured into concepts and conceptual relations (Tsoukas, 1997). Yet, various studies have shown even seemingly mundane and repetitive tasks such as repairing photocopiers or highly professionalized work in hospitals require practical, reflective and often creative forms of knowing in addition to a grasp of formalized concepts, logics or plans to attend to continually changing situational demands (e.g. Orr 1996; Jordan 2010).
Wherever practical knowledge meets formal procedures, there arises the opportunity for mētic behavior, as a superior grasp of particulars affords endless opportunities for gaining small advantages (Scott, 1998: 256), and in particular public administrations and private organizational bureaucracies represent a fertile ground for mētis. As Fukuyama (2004: 199) notes: "The most successful programs are often idiosyncratic, involving … mētis, the ability to use local knowledge to create local solutions". Mētis has accordingly been observed in the maneuvers of politicians and FBI agents, for example in the wake of the Watergate scandal (Newswander and Newswander, 2013).
Similarly, Collin et al.'s (2011) ethnographic exploration of work life in a Finnish hospital uncovers everyday behaviors by nursing staff that obliquely and subtly contest the formal power and authority of surgeons and doctor. For example, in one instance, a lead operating theatre nurse is observed to deliberately conceal a scalpel in order to prevent a notoriously headstrong surgeon commencing a procedure until the nurse is satisfied that all her team are ready to start the operation safely.
A further example is offered by Bouty and Gomez (2010) who recount how restaurant kitchen staff structured work practices in ways that hindered the chef's control.
Similarly, in their study of a financial service organization, Corbett-Etchevers and Mounoud (2011) find instances in which individuals attribute meanings and uses to knowledge management practices that differ from the stated intentions of the producers; while Dovey and Fenech (2007) examine how middle managers subvert a formal change programme in an Australian financial services organization. These examples from organizational practice are glimpses of actions grounded in mētis that undermine officially sanctioned or taken-for-granted conceptions towards a range of outcomes ranging from righteously to self-servingly motivated.
These snippets of organizational life show mētic activity as an everyday occurrence which often goes unnoticed and sometimes occurs at the boundaries of what is considered ethically or even legally sound. Letiche and Statler (2005), for example, draw attention to the frequent association of mētis with violence, recklessness and unpredictability. Recurring references to the darker side of mētis also reveal how fundamentally such behavior is at odds not just with 'Western' value systems (Detienne and Vernant, 1978;Toulmin, 2001), but also with an aesthetic preference for visual order, clarity, and openness, coupled with a deep mistrust of messiness and all things occult, oblique, hidden or subversive (e.g. Tosey, 1989;Tsoukas, 1997).
Mētis thus seems to be the shadowy stuff that happens away from the well-lit main roads, allowing for the 'intricate minglings of uses and complex interweaving of paths' that make up the vibrant undergrowth of a city (Jacobs, 1991: 442). between 'plan' and 'plot', referring to conspiracy or contrivance. The righteousness of either standard, he argues, depends much on the recipients of these actions, either 'our own people', or 'the enemy', against whom trickery could be an acceptable, if not admirable course of action.
In examining mētis we are thus urged to consider the origins of our traditional preferences for light, clarity and order, so as to be able to appreciate this form of knowing which remains in the space between light and dark, oscillating between logos and chaos (Detienne and Vernant, 1978). 1 It is worth noting that Freedman's nearly 800 page long 'Strategy: A History' pictures on its cover the 'Trojan Horse', a trick devised by Odysseus, indicating the historical importance of mētis in warfare.

Practical wisdom: Phronesis and mētis
We can begin our exploration of mētis by returning to Chia and Holt's (2009: 105) invocation of 'phronesis'. Three characteristics of practical wisdom in the form of phronesis are helpful for our understanding of mētis. Firstly, phronetic action is not exhausted by universal rules; it also requires knowing how, when, where and in what way to apply rules (MacIntyre, 2006: 164). It is thus not sufficient to act courageously or temperately (those being other virtues), but also to know when it is right not to do sosuch judgment is exercised proficiently by a phronetic person based on their practical, situational intelligence.
Secondly, whilst phronesis may lead to alternative courses of actions in line with situational demands, and while it cannot be reduced to a set of universal rules, it is still tied to what Aristotle calls "a stable and unchangeable state of character" (NE II.2,4.25). This suggests that a phronetic disposition cannot be acquired through books alone, but requires experiential learning and tacit familiarity with the particulars of a situation so as to be able to efficaciously deliberate what forwards particular ends (Russell, 2009: 6). 'Only through much time', Aristotle argues, 'is life experience possible' (Dreyfus, 2004: 269). The development of a kind of perception underpins resourcefulness and responsiveness and the 'ability to recognize, acknowledge, respond to, [and] pick out certain salient features of a complex situation' when dealing with the contingencies of (organizational) life (Nussbaum, 1986: 305).
Thirdly, despite the importance of habitualised and embodied knowledge, phronesis is not exhausted by our understanding of 'skills'. While Aristotle was somewhat ambiguous about the relationship between the skills involved in making something and phronetic action 2 , there seems to be a difference in the ends pursued. We can make things, and thus employ our skills (techne), for many purposes; but phronetic action is an end in itself, so that: "a craftsman can excuse his having made a poor artifact by saying that he made it that way on purpose, but one cannot excuse one's bad actions in this way" (Russell, 2009: 17).
Phronesis therefore denotes a virtuous practical intelligence that is not so much some-'thing' one can possess, but it denotes a 'cultural virtuoso' (see Dreyfus, 2004) whose bodily intelligence or disposition allows to "react emotionally at the appropriate times, about the appropriate things, to an appropriate degree, and so on, and to desire and aim at the appropriate kinds or ends of targets" (Russell, 2009: 13;18). In invoking phronesis, Chia and Holt (2009) try to illustrate a rather different kind of knowledge when compared to that entailed in the conceptual metalanguage of most organizational research. Phronesis suggests a sense for a wider context; of being 'a system-in-a-system' (Chia and Holt, 2009: 135) whose judgments and decisions exhibit a wisdom about a life-form as a whole (Russell, 2009), rather than merely skill See, for instance, Dunne's (2009) separation of phronesis and techne or, alternatively, Dreyfus's (2004) discussion of phronesis in relation to expertise and skill.
in production or knowledge based on abstract concepts. The possibility of practical intelligence in the form of phronesis therefore also presents a further alternative to the ideal of modern science which, for Flyvbjerg (2001), offers a desirable orientation in social research. However, attempting to flesh out such an orientation represents a slippery slope towards stipulating new universal statements and rules and thus losing what phronesis is (c.f. Schatzki, 2002).
We can draw on this characterization of phronesis to illuminate mētis, about which less has been written and of which no 'structured' accounts (can) exist. Whilst bearing many similarities with phronesis, mētis operates, according to Raphals (1992: 5), 'with a peculiar twist'. As practical wisdom, mētis embraces the particulars of a situation; it involves a stability of character; and it entails a sense for wider relations.
However, unlike phronesis, it does so in an inherently indirect fashion, presenting us with a 'continuum of wisdom and cunning' (ibid: 4). Mētis thus never manifests itself openly for what it is; remaining forever "immersed in a practice that has not the slightest interest, at any moment, in explicating its nature or justifying its procedures" (Detienne and Vernant, 1978: 9).
The word 'mētis' itself entails a number of twists. In Greek mythology, Hesiod's 'Theogony' (transl. Brown, 1953) invokes mētis to describe a set of characteristics attributed to a resourceful and clever person, and yet Mētis the also name of a goddess who became the first wife of Zeus and "who had in her mind all the wisdom of the gods and men" (Servi, 1997: 27) 3 . The form of the word is also interesting.
Separately, the Greek words 'me tis' mean 'no man', or 'not someone', and only when joined do they relate to a person (Eickhoff, 2001: n4;404). Homer's Odysseus, who is renowned for his mētic ruses, for example, when held captive by a Cyclops, is asked about his name and responds: 'Nobody [Outis] is my name'and in this cunning play on words Odysseus both disguises himself, while at the same time revealing who he really 'is': a character of devious shrewdness and sly intelligence (Vernant and Ker, 1999: 7). The very form of the word therefore hints at the mētic tendencies for dissimulation, ruses, and that nothing necessarily is what it seems. And so we find Homer (a name that is itself a moniker for a nameless collective) confining his hero to perpetual mobility; his life a restless odyssey of predicaments that require ever new and creative responses while, at the same time, being trusted less and less by those who know him, even when he is being straight (Freedman, 2013: 28).
While mētic behavior was an accepted, even heroic form of engagement in ancient mythologies, our more contemporary connotations of 'cunning' behaviour invoke a range of usually adverse moral or value judgments. Yet, Raphals (1992) takes the original meaning of mētis to be neutrally amoral; a form of knowing tied to the immanence of a situation, emerging or receding in the moment from the relationship between a proponent and circumstances, and directed towards a range of outcomes from the emancipatory to the subversive (de Certeau, 1988). 3 we will speak of the 'Goddess Metis' when referring to the person and of 'mētis'

when indicating situated resourcefulness
Here we can attempt a further distinction from phronesis. The pursuit of appropriate ends marks a phronimos as someone whose actions lead, contribute to, or at least are undertaken with the intention of producing overall or systematic 'good consequences' 4 ; the good life (eudaimonia) generally. This, however, imposes the paradox that what a 'good end' is cannot be judged outside of the particular form of life and specific context into which one is thrown.
Mētis, on the other hand, lacks such appeal to the good life. Chia and Holt (2009: 200), for instance, discuss the 'mētic' guerilla tactics of 'Lawrence of Arabia' in World War I. Avoiding open confrontation enabled his less organized and outnumbered troops to pose a largely invisible but highly efficient disturbance to a visible and organized opposing force. However, these successes were short-lived and the military gains of the Arabic troops -and more-were soon lost in the realm of postconflict politics. Mētis's twist seems to represent a potential to fleetingly torque that which appears stable and harmonious; and apparently orderly situations may be thrown out of kilter when previously undetected, pent up tension is released through mētic intervention.
In lacking the appeal to the 'good life', mētis seems to engender a less exalted and perhaps more active mode of engagement. Phronesis, we recall, draws on rich life experience as there can be no universal frame of normative expectations against which the suitability of an action may be judgedsuch expectations are only possible in production activities (techne). Phronesis, Schnadelbach (1987: 235) argues, may thus 'at best' realize situationally specific rules; reducing knowledge to a subjective, private morality. But, asks Schnadebach, 'does not such a morality in a technologically and rationally scientific world lead to a reactive conservatism that understands or legitimizes what is, or what has happened, only after the fact' (ibid: 227)? In other words, does the appeal to the 'good' invoke the sublimation of knowledge by suggesting it is possible to dig out the 'essence' of what a good life may be (Mulhall: 2001: 88)? We may thus ask, after Wittgenstein (1998: §132), whether such sublimation runs danger of becoming 'an engine idling'; nonsense at best or, as Schnadelbach (1987: 235) suggests, a tendency for conservatism where action is continually suspended in favor of re-actions and past experiences that remain within existing institutional boundaries.
Based on this characterization of phronesis, we can begin to sketch mētis as an active, spontaneous, but also value neutral form of engagement. We therefore translate it as 'situated resourcefulness': 'situated' because its enactment is wholly circumstantial, resisting abstraction into categories, and 'resourceful' to indicate the spontaneity of its intuitive, creative responses to circumstances. Its wisdom is engendered by cleverness, and through ruses and shortcuts, enabling individuals to gain momentary advantages by influencing events in their favor or exploiting opportunities that others overlook (Baumard, 1999: 54, 64). For Detienne and Vernant (1978), this fluid form of knowing works between, or rather underneath, the formal order of concepts. Mētis seems to flourish particularly where it can exploit the complexities, ambiguities, and paradoxes that come with simplified abstractions, or when it can manipulate them so that they discord with our practical understandings of the world.
Despite its apparent importance, mētis has only limitedly been explored (Jullien, 2004: 191). To further our examination of mētis, we firstly turn to some of the central relations in Hesiod's Theogony. We do so as the questioning and unsettling quality of myths have been utilized in a variety of organizational studies (Gabriel, 2003;Hjorth and Pelzer, 2007;Stein, 2005) as an indirect means of exploring ephemeral phenomena that resist conceptual classifications. Such a means seems relevant to an investigation of mētis as myths do not communicate fixed messages but afford investigation of all aspects of human experience without explicit concern for the boundaries of science or logic (Gabriel, 1995;Greenham, 2006). This also helps to distinguish the mythological meaning of mētis from the modern terms cunning, trickery, bricolage, or tactics.

Mētis in Greek mythology
Mētis is representative of an important theme in the Theogony: that victories can be gained through resourcefulness, obliquity and improvised actions, and that situated resourcefulness will triumph over the directness of brute force, strength and violence.
It has come to stand for a tendency to seek out circumstances where one's experiential insights might foster the potential for situational resourcefulness. Displays of practical knowing in the form of mētis reverberate through ancient Greek mythology, as those able to exploit it are shown to survive and succeed in uncertain, challenging and ever unfolding situations (Detienne and Vernant, 1978). Through the Theogony, we can get a sense of the origin and character in the context of Gods and Muses; allowing us to begin to appreciate mētis with some distance from prevailing boundaries and dichotomies which characterize modern thinking (Greenham, 2006).
The Theogony provides an account of the balance of divine powers that emerged until, under the rule of Zeus, the definite order of the universe was established. The first instance of mētic activity follows a primal act of division; the creation of a form (c.f. Spencer Brown, 1969: 2) thorough the distinction between a female principle: earth (Gaia), and a male principle: sky (Uranus). This severance sets in motion cycles of procreation and natural generational succession, and therefore a continuous process of change. Aware of the fleeting nature of his own supreme position, Uranus forces his children back into the subterranean prison of Gaia's womb in an attempt at countering the natural and However, aided by Gaya, one of the children named Cronus surprises and ambushes Uranus, mutilating him and forcing him to retreat into the heavens. Cronus then fills the vacant supreme role and reigns in Uranus's stead (Detienne and Vernant, 1978: 64).
Once in his proper place of power Cronus, like his father before him, attempts to suppress the rise of his own children by swallowing them as soon as they are born.
However, Cronus is outdone by his wife, Rhea, who saves her son Zeus by handing Cronus a stone wrapped in swaddling clothes instead of her newborn child which, she knows, he will greedily devour without further inspection. Remaining hidden until fully grown, Zeus is able to defeat the superior force (bie) of Cronus through a set of clever tactics which Zeus devises with help of his wife, the goddess Mētis.
The myths of the Theogony provide us with a sense of the problems and interactions of the immortals and in so doing show us the characteristics and recursive implications of both force and mētis. Both Uranus and Cronus attempted to resist the changes brought by generational succession using their power to enforce stability (Strauss Clay, 2003: 14). In forcefully hiding their offspring from sight, both seek to control their environments to ensure the continuation of their reign. Yet both fail to recognize the fragility of the ensuing stability, as below the seemingly controlled order resentments begin to fester, engendering a recursive cycle between parent and child in a violent deed (bie) leads to the plotting of revenge (ibid: 18). When Uranus goes about his routine behavior, and when Cronus devours the stone, both mistakenly believe they can do so safely, having regulated the possibility of generational change.
Yet, both fail to spot the particulars of the situation, which makes them vulnerable to the cunning of the Goddesses (Gaia, Rhea, and Mētis) who comprehend this complacency and help conceive the traps (Detienne and Vernant, 1978: 67).
The Theogony portrays a cosmos that is not only dynamic, but also full of tensions and polarities, recurring at every level (Brown, 1953: 42). It shows how top-down systems of order and control can be blind to the nuances that open up in the shadows cast by formal structures. Similar to shortcuts used by local pedestrians, Hesiod's cosmos affords those with experience and local familiarity the opportunity to outwit those in control; and just as the efficacy of shortcuts depends on their absence from official maps and metropolitan control, the potential for metis increases with the degree of ignorance that prevails about situational particulars. Gaya and Mētis benefit from awareness of their husbands' complacency and the efficacy of their situational resourcefulness corresponds to their ability to turn this knowledge into expedient action.
However, through Zeus's story the Theogony also provides an account of a more balanced way of maintaining order and a change in modus operandi that supports the continuation of his reign. Forewarned by prophecy of his children's power, Zeus first tricks and then swallows his pregnant wife, the Goddess Mētis, so that it is he who gives birth to their daughter, the Goddess Athena (springing from his head, fully formed and clad in armor). By swallowing Mētis, Zeus combines within him the prudence of the Goddess with his inherited capacity for force. Henceforth Detienne and Vernant (1978: 14) note, 'there could be no mētis possible without Zeus or directed against him'. Through the mētis in him, Zeus reads situational possibilities comprehensively, and there is no 'gap between a plan and its fulfillment such as enables the unexpected to intervene' (ibid: 14). Thus a delicate balance to the tension between mētis and bie (direct force) is introduced to the world of the Gods (Brown, 1952).
The mythology of the Theogony suggests that antagonism and reconciliation, as well as difference and union belong together in the sense that Heraclitus suggested that 'harmony is unity in contrariety' (Greenham, 2006: 33). Uranus and Cronus fail to see is that there is no enduring control and their deeds come back to haunt them. Hesiod's myth suggests that masculine control can only ever be a temporary pacing of the procreative and proliferating feminine power. Understanding this fundamental principle of recursion allows Zeus to prevail by straddling these two opposites. The harmony of his reign is not the opposite of an otherwise chaotic world, but polarities held together in tension (ibid: 33).

From mythology to social science
Recourse to mythology allows us to approach metis outside of the clear-cut boundaries and neat categories of thought and fixed forms that characterize most business and management studies (Cooper, 1986). Our trust in such boundaries and categories, and consequently in instruments of measurement and control, corresponds with Plato's appeal for truths that are not rooted in distorted and fallible human beliefs, but instead are based on a starting point that is 'eternal, stable, and not relative in any way to the conditions and contexts of human life and language" (Nussbaum, 1986: 242). With Plato came the necessity for philosophy and a certain 'joy and exhilaration' when we discover structure and order in the otherwise 'messy, unclear stuff' of human life; when we are directed away from the darkness of the cave into the clarity of light (ibid: 260).
Aristotle's subsequent critique of Plato's ideal forms rests on his illustrations of the acute dangers of oversimplification whenever we begin to theorize in such a fashion.
Aristotle's return to practical wisdom represents a return to the ordinary aspects of life, making these 'an object of interest and pleasure, rather than contempt' (Nussbaum, 1986: 260). Aristotle's phronesis can thus be understood as a response to Plato, aimed at the recovery of appearances. Mētis, however, emerges in Greek mythology long before the split of truth and appearance, in a time when logic and myth were indistinct. Then, myths provided the main reference points for human experience (Bowles, 1989), occupying a diffuse space between truth and falsehood in which mythos and logos originally had the same meaning -referring to a 'word or 'story' (Greenham, 2006: 27).
In these origins, there was no access to truth beyond what was said and thought. Any later separation of rational and mythical thinking only makes sense in terms of the Platonic ideal of perfect knowledge and, in its modern guise, in methodological differentiations between alternative fields of enquiry (Heidegger, 1954: 7). Only in methodological terms can it therefore make sense to say that a myth is false and logic is rational (Greenham, 2006: 27). Thusly understood, the task of the myth is to speculate upon origins of human experience, which may serve to unsettle received opinion. Myths may therefore be particularly suited for exploring mētis -their refusal to take single positions places myths in an innocent space between true accounts (euhemerism) and made up inventions (poiesis), and in 'resting there restlessly' (ibid: 2, 7), they share the unsettling character of mētis.
Recourse to mythology indicates that the register of social science that depends upon fixed boundaries and stable categories may be inadequate when attempting to deal with aspects of organizational life that not only resists measurement but whose covert efficacy increases with our efforts at confining them into explicit frames. Mētis can neither be researched or communicated directly (Baumard, 2003) and in attempting to grasp its essence it seems that we generate another paradox: that the more we know about itthe more light we try to shed on its characteristics -the less it is what it is (Chia and Holt, 2009: 196). Knowledge based on stable concepts is therefore inadequate in addressing action in practice, as practical action is neither exhausted by universal rules, nor by habituated skills. The former cannot accommodate the required situational intelligence, while the latter struggles to integrate judgments based on more holistic concerns.
A mythological account involves a shift in register in the ways in which social science is done; moving away from references to logic and towards a form of knowledge that deals with each situation as it comes without looking beyond it for a yardstick against which a decision can be measured. Mythology allows us to probe into the grey areas which escape the views of the conceptual cartographer in which those dwelling 'down below' amidst the 'thicks and thins' of an organizational context live out a host of 'microbe-like, singular and plural practices' (Certeau, 1988: 93-96).
In explaining how we might use myths, Barthes (2009) suggests that, as they exist harmoniously alongside actuality and, in being kept alive, they may afford one further step into the hermeneutic circle of action and context that resists conceptually rational untwining. The shift in register from concept-based social science to approaches that hold interpretation open therefore also includes a new division of labor between author and reader, as the latter is no longer the passive recipient of fully formalized ideas, but takes an active role in the restless negotiation of possible meanings. In the following sections, we invite the reader to consider mētis through this sort of active engagement when reviewing an episode of mētic behavior in a contemporary organizational setting.

Study design and methods
To complement Hesiod's myths, we present an organizational episode in which we suggest oblique mētic behavior was at play, and which we encountered as part of a qualitative longitudinal case study examining strategy work in a large government funded and mandated organization in the UK. Based on an intensive research design (Sayer, 1992(Sayer, , 2000, the main study employed a number of qualitative methods to collect and analyze data, including participant observation, multi-level interviews, documentary analysis and secondary archival analysis. Data were collected over a two-year period from March 2009 until May 2011 and used to construct extensive narratives detailing actions, interactions and outcomes of those in and associated with the organization, as they pursued four separate espoused 'strategic initiatives'. Each narrative covered the duration of one such strategic initiative, ranging from 6 to 12 months. We then broke each narrative down 45-67 smaller episodes, one of which was the independent audit of a department, on which we focus later. The stimulus for this paper came from our observation of what we later identified as 'situated resourcefulness' -or mētis in action -as seemingly an accepted part of organizational life and the quotidian work of strategy, as observed within and across narratives. However, we found very little explicit discussion of mētis in either the literature on organizations, strategy, or learning (Letiche and Statler (2005), Baumard (1999) and Chia and Holt (2009)

being exceptions).
As a first step in analyzing this kind of activity, we began to extend our consideration of the literature into the area of philosophy and mythology, guided by the Raphals's (1992: xi) warning that 'mētis is easier to recognize than to talk about'. We continually revisited the case data, regularly involving employees from the organization in making sense of episodes; invoking, examining and critically evaluating our newly found ideas about mētis in the process. After some time, we felt that we began to develop a saturated sense for mētic behaviours, linking those of the Theogony with those of the organization we researched without, however, employing or striving for -a precise conceptual logic for this.
The illustrative episode portrayed in the following section is informed by participant observation notes, documentary analysis of media sources, and data from 1 to 1.5 hour interviews with 12 managers within the organization conducted between November 2010 and May 2011.One reason this episode was selected was that the authoring team all agreed that they felt much situated resourcefulness to be at play. A second reason for choosing this episode was that most of the other candidate episodes we discussed entailed merely short lived, fleeting, and punctuated mētic maneuvers.
The episode we selected was somewhat 'bigger' and its outcomes more tangible, thus making it easier to talk about the processes of resourcefulness in the context of a journal article.

Illustrative Episode -The Audit
In early 2010, a new manager, who we call Joe, was appointed head of one of the departments in the case organization. At the time, the department comprised around 160 staff, largely providing sector specific commercial services and technical expertise whilst exhibiting strongly institutionalized and formalized procedures (c.f. Brignall and Modell 2000). While the employees of the department were not civil servants, many of them had worked in publicly funded contexts for a long time, typically on rolling contracts. In the wake of public service accountability directives in the UK, the continuation of their employment depended upon demonstrated performance and impact of the work conducted by the department.
To this effect, the department, as well as the wider organization, regularly disclosed econometric information relating to indicators such as cost and impact. Department heads experienced sustained pressure to maintain and disclose a plethora of performance metric information as part of a discourse of justifying the investment of 'taxpayers' money' in the broader organization, resulting in a "metric based organization … where decision processes are highly numerical and aimed towards giving a number that justifies what we are doing." (manager 3, interview notes) Published performance measures also served to legitimate the continued existence of the department in budget discussions with civil servants, and were frequently cited by politicians as evidence of the impact of their policies. Such exposure tended to inflate the figures returned whilst increasing the complexity and intensity of the task of managing in the department: "in our planning and reporting, we suffer from what we call optimisation bias, which is basically we are hoping that something will be much better than it really will be. No single assumption is bad on its own but put together them all and you multiply the problems you are going to have…. your system drives you towards stuff and encourages you to do stuff because thinking like this ends up getting an in-bred optimisation bias built in to everything we do." (manager 1, interview noteswords in italics were emphasized by interviewee).
Prior to this appointment, Joe had been a senior manager in the organization for 5 years and had served as head of a number of other departments and in various other functions as well. When we began our research, the organization had just been publicly praised by its funders for its excellent performance against a primary indicator of economic value generated in comparison to the cost of running the organization. Indeed, the department we focus on had experienced several years of having reported over-delivery of its published targets to the extent that it was seen as "the good news factory" for the broader organization (manager 11, interview notes).
In 2009, on the basis of its perceived trajectory, the then manager of the department had committed to a range of stretching econometric performance growth targets (towards tripling economic value returned over three years). In 2010, published performance results reported in a range of national newspapers indicated that the department was exceeding its 'breakeven' economic value creation targets by over 800%.
Approximately six months into Joe's appointment, the department was informed that an independent audit would be initiated within a few weeks, led by an external consultant. The department had been randomly selected for this audit, which was to investigate performance reporting procedures and delivered outcomes. In our discussions with staff we picked up a number of remarks which seemed to suggest that the audit may be problematic as there was some concern about the validity of the performance reporting procedures and published results.
Attempting to better understand these concerns and to trace how the formally reported quarterly results were worked out, we sought views from the management team. We found that reported results originated from "theoretical models used to produce a number based on limited data" (manager 1, interview notes) underpinned by a labyrinthine set of clauses and exceptions determined by the department's management team. Furthermore, the calculation process appeared to be fed by what was frequently described to us as 'guestimates'for many individuals connected with the process, where hard data was not available, projected figures were used as acceptable substitutes, only without accompanying statements identifying the numbers as educated guesses. As one manager commented, "…if we are struggling against internal performance targets we just give a story, particularly in the current economic environment, or we feed in a reasonable forecast instead of concrete results" (manager 7, interview notes).
Given the nature of the service provided by the department, many of the employees had joined with careers steeped in experience calculating and managing by econometric measures. These managers suggested to us that whilst the organization had indeed delivered a net economic benefit to funders, on 'best estimate' terms, this return was significantly below the stretching targets they had committed to several years previously, and certainly differed from the figures reported on a quarterly basis.
The following statement is worth quoting at length: "We look like we are performing to plan but that is easy. No one at the top of the organization really gets what we do, they just want their name in the right places and associated with our successes; and our department contributes disproportionately to the success of the overall organization. They want the credit but none of the effort… and not a lot of questions are asked of our figures … and don't get me wrong, we do achieve things -sometimes quite exceptional things, and the money spent does deliver net benefits. It's just that it's hidden well when we don't. It helps that we work with projections, and the companies we work with, well, basically they know the game. To get funding, they have to sign off on the figures we want. Why would they not? It's written down that they are forecasts and they know we won't monitor whether these actually happen or not. Or they like the advisor they've been working with for a long time. All we then need is one company to sign off on some big forecast numbers and we can report hitting our targets overall; and no-one will ask about how it all worked out… " (manager 5, interview notes) Despite this view, data were presented in an unambiguous way and the published information on the department's performance didn't explain how outputs had been computed nor were, as best we could determine, such details communicated openly in organizational meetings. In the period leading up to the audit, including various preparatory meetings, we did not witness any attempts at correcting the published figures or otherwise manipulating the reporting system.
The audit, then, began with a 'kick-off' meeting, which was attended by Joe, several of the department's managers, one of the authors (taking notes, but not recording the conversation) and the external consultant who was to conduct the audit. In his introductory talk, Joe explicitly stressed the high standard of transparent working of the department and the general commitment shared by department to the value and importance of the audit process. Joe then talked at considerable length about the number of upcoming projects in the department and the organization at largeinformation that was not directly relevant to the meeting, as the audit focused on the department's past performance. Joe then stressed how these developments would lead to further auditing processes in the department and the organization at large, and emphasized the role which he, as an experienced senior manager, would play in the selection of the auditor to be used. He also stressed the role of politics in audit processes; hinting that speedy progress and a subsequent positive audit result would also shine a 'positive light' on the auditor and that such a light may help in securing further contracts with the organization.
In the course of the remainder of this meeting, Joe managed to negotiate an agreement with the auditor that physical inspection of original department records was not necessary, as it would only inconvenience the auditor and hold up the department's ongoing work at a crucial time for current major projects. Instead, the audit was to be conducted on the basis of previously issued quarterly reports with supporting quantified data and supplementary customer information, all provided by Joe to the auditor electronically.
The actual audit process then consisted largely of Joe emailing materials to the external consultant, on the basis of which a thick audit report was compiled.
Approximately 30 pages of the report explained the use of statistical methods and emphasized the rigor and validity of the ways in which the figures were computed. At no point, however, was it mentioned that the raw data for the report was entirely collected and validated by Joe rather than the auditor.
It is important to highlight that the influence on this episode was conducted with great subtlety by Joe. For instance, Joe wove in the issue of politics and his own importance when it came to selecting an auditor into what sounded like an anecdotal story about how the organization had dealt efficiently with bureaucratic processes. Neither did the researcher present at the meeting notice, or indeed record in the field-notes, that any blunt effort at influencing or intimidating the auditor was going on. Only later, through the process of reviewing the meeting through interview with two of the managers present, did the sort of comment expressed by one of the managers start to surface -"these evaluations are always done by third party consultants who know the way this all works. I mean have we ever had one done by any of the big firms? Of course not, because they would follow procedures exactly. We use this local firm because they know the gamethey send the same consultants to do the same reports which rely on information from us. Of course they know the game…. they make us look bad then they won't get the work next time around." (manager 2, interview notes).
Unsurprisingly, the results of the audit report confirmed the previously published figures which were, in the report, lavishly garnished with positive quotes from the department's clients, also provided by Joe. Indeed, so impressive were the reported results that the 'good news factory' produced another output. Shortly after the audit report was published, the press office of the wider organization issued a story to a number of national media outlets, and news of the excellent performance went into print, accompanied by various graphs and ratios. This story was duly published along with a picture of Joe and supporting comments from delighted clients in several broadsheet newspapers.

Discussion
Drawing on our earlier interpretation of the Theogony, we can begin to outline some of the characteristics of what we have interpreted as Joe's situated resourcefulness.

Complexity and complacency in measurement systems
The audit episode is indicative of a number of simplifying abstractions and the effects of measurement systems. It shows that the 'rationality of planning' employed to generate a rational justification for the department's existence (c.f. Townley et al., 2003Townley et al., : 1046 was inadequate to control the practical situation, which was far more complex; which contained elements irreducible to words and numbers or, at least, in need of situational interpretation; and which generated a response by those measured, leading to the 'guesstimates' that 'fit the bill'. The scope for mētic responses was heightened by the degree of trust placed in rational, measured, and conceptual realities. Neither the main organization's management team nor the organization's funders challenged the ever-improving performance results returned by Joe's department, instead finding comfort and even gain in the apparently beneficial trends. The auditor and the newspapers reporting the department's success were equally complacent in trusting the figures provided. In similar fashion, Uranus and Cronus believe the surface order established through their interventions to be indicative of stability and safety (Detienne and Vernant, 1978: 67).
Yet, both in the Theogony as well as the department and broader organization, trust in surface appearances was misplaced and first gave rise to the neglect of influential undercurrents that then both afforded and required mētic maneuvers. This created a number of further dependencies which make any later changes to that system much more difficult, expensive and dangerous than the initial act.
Not only did these outstanding results lead to higher expectations and farther reaching promises for the future, it also buried a problem in the department's past that could have reemerged at any point. This is homologous to Uranus' and Cronus' hiding of their 'problems' which ultimately leads to the loss of their position. The order Cronus creates is only fleeting: his problems are merely hidden away, preserved, and generational change is only temporarily slowed down as he mistakes the tidy order he has established for an enduring state.
Myths therefore remind us of the illusiveness of conceptual order and clarity. They present, like a 'constantly moving turnstile' (Barthes, 2009: 147), alternate glimpses of a literal sense, as well wider possible relations and in holding different levels of meaning in suspension, they may act as a springboard into a more holistic and 'messy' exploration of aspects of contemporary [organizational] life. In the cosmos of the Theogony and in our department alike, a recursive cycle leads to higher complexity and intensification of relations. In this sense, both future and past are unknowable. Hidden events continually disrupt the seeming order. Like the surgeon who Collin et al. (2011) show to be outwitted by the lead nurse, belief in formal status and, more generally, complacent trust in surface appearances feeds the propensity to be caught off guard by others.

Practical wisdom and Mētis
This brings us to the question of whether Joe's actions are phronetic or mētic, or whether such an evaluation can be sensibly drawn in the first place. Instead of directly confronting matters, Joe skillfully utilized the audit meeting to change the situation in his favor. His actions were subtle and attuned to circumstances, resisting codification in terms of 'rules'. On this and various other occasions, he showed a certain 'stability of character' without, however, this being mere habituated skill. Yet, it remains impossible to make a judgment on whether Joe's actions were truly phronetic i.e.
whether they contributed to a 'good life' as discussed above. Such judgment cannot be made from outside of the particular situation (Schnadelbach, 1987). What we can suggest, however, is that Joe's actions were not conservatively reactive. Like Rhea and Gaia who faced the risk of Cronus discovering the wrapped stone, or Uranus diverting from his habit, Joe risked having his bluff called by the auditor, the press, or the funding bodies involved. In setting the trap, the mētic operators torque the apparent surface harmony and thereby add a further twist to an already tension laden relationship which may erupt at any later point in time.
Moreover, Joe's actions show an acute awareness of wider conditions, such as the workings of the organization's measurement systems, the political climate; the employment implications tied to particular results for many staff; and the general 'good' his department produces, even if the associated claims may be grossly inflated.
In other words, Joe did seem to have a sense for the wider relations in which he and his department were entangled, but rather than being paralyzed by the complexity of these relations, or by calculations of the consequences of his actions, his modus operandi consisted of many little tricks and maneuversand the constancy of his actions was the ability to remain maneuverable and nimble.
This echoes the balance of force and trickery ascribed to Zeus in the Theogony. Zeus manages to remain the head of the cosmic boardroom because he is both strong and wise; shifting his efforts from trying to enforce and maintain order towards keeping a balance between differing interests and forces (Brown, 1953: 24). Zeus' world is not tidy; it is a precarious equilibrium that needs constant attention and readjustment; a brittle harmony between forces; between creatures of light and darkness; between strength and mētisa world that causes him a constant headache. Nevertheless, this suggests the possibility of a different modus operandi for management; one that makes small, reversible interventions and recognizes the need for practical experience when interpreting the results of each small change to determine the next step (Scott, 1998: 328).

Mētis and learning
A somewhat altered ideal of learning emerges from this characterization of mētis.
Rather than preferring either conceptual, or situational knowledge, or alternatively, habituated skill, mētis occupies a space in-between. Joe was experienced in the ways in which measurements were compiled and audits conductedand thus how conceptual abstractions were generated and treated. Having gone through several of them before in different departments, Joe knew what auditors would be looking for and what they tended to take for granted. Rhea similarly was aware of Cronus' greed and the likelihood of his taking a stone wrapped in clothes for the child, while Gaia knew of Uranus's habits when setting a trap. However, a considerable risk remained.
In addition, Joe had a good understanding of the particulars of the situation. He knew of the falsity of the figures, but also of the processes in which the audit report was to be created. This allowed him to suggest, and later deliver, a rigorous set of quantitative data that afforded 'adequate' interpretation by the auditor. Cronus, by comparison, paid no attention to particulars; the differences between the appearance of a boy and a stone wrapped in clothes eluding him. His insensitivity to that difference opened up the space for Rhea's trickery.
Finally, Joe was able to skillfully exploit his knowledge of appearances and of the difference between appearance and territory to fashion a ruse, in the form of a convincing set of quantitative data, which would satisfy the auditor. He also showed great skill in the kick-off meeting, when he subtly persuaded the auditor of proceeding according to his suggestions. Joe was also able to select the right moment, the audit kick-off meeting in which he had a prominent slot to speak, and apply the appropriate rhetoric to generate and grasp his opportunities in the moment in order to create more favourable conditions (de Certeau, 1988). Rhea's ability to select a stone and to wrap and present it in an inconspicuous manner equally indicates her ability to act upon her knowledge. Baumard (1999: 69) calls such mastery of terrain and technology a 'connivance with the real'. In this way, mētis is the "diametric opposite of impulsiveness" (Detienne & Vernant, 1978: 15). Despite its resourceful nature, such practical wisdom incorporates an almost forensic attention to detail and an immaculate sense of timing grounded in experience.
This, however, should not read like a sublimation of mētic knowledge in the ways in which the phronetic 'cultural virtuoso' (see Dreyfus, 2004) may be perceived. It suffices for mētic actors to remain in-between conceptual, situational and skillful kinds of knowledge, able to trade their differences off against each other and benefit from the arbitrage. Perhaps it is helpful to approach mētis not as a superior, or more advanced kind of knowledge, which may be gained through additional learning, but as having less proper knowledge. When we 'unlearn' and thereby wean ourselves off our dependency on knowing something in the first place we may also escape our false sense of security about our knowing of the nature of world which exposes us to potential exploitation by the trickery of others (Toulmin, 2001;Chia and Holt, 2007).
Interestingly, most of us in our early childhood were able to do this without problem, for instance when painting pictures that were not constrained by the urge to produce accurate representations (Ehrenzweig, 1967). It is because the doodles of children do not allow for the efficiencies of communication that only come when the (organizational) world is grasped as a field of identifiable objects and forms (Cooper, 2013: 598) -and therefore with the singular certainty provided by conceptual logics without the need to ask each time: 'what does this mean? ' (c.f. Ruesch and Bateson, 1951).

Conclusions
We began our paper with the suggestion that knowledge based on stable concepts is inadequate in addressing action in practice, and yet much of management draws on measurements to rationally legitimize, control, compare, or rearrange the workplace.
The consideration of phronesis goes some way to address this inadequacy by stressing the importance of situational awareness, steadfastness of character -without reducing this to rules -, as well as practical skill. However, questions remain about what it means to act towards a good life, especially when we attempt to transport this idea from ancient Greece to modern life.
Without aspiring to the sublime, mētic actions are radically situational and cohere merely in their persistent withdrawal from direct inspection so that nothing necessarily is what it seems (Vernant and Ker, 1999: 7). This goes first and foremost for mētis itself, as it forever resists conceptual arrest. Mētis is someone and no-one and thus its form reflects our experience of concepts and measurements that populate the world of business and management. Performance indicators or auditable processes always only represent a small number of possible facts selected according to narrowly defined sets of purposes (Scott, 1998: 109). Every abstracted fact represents an invitation for playful, subversive or cunning responses, as facts by themselves cannot establish practice but leave behind a difference between abstraction and lived worldand this difference can feed mētic exploitation.
Mētis reminds us of the fallacy of believing that we can manage the world by tightening our conceptual grasp and manipulating our surroundings through selective 'facts'. Light, Wittgenstein (1969: §139) says, 'dawns gradually over the whole' and we may do well in acknowledging the importance of the twilight of knowledge. This sense for a 'whole' that is germane to situated resourcefulness may also help distinguish it from modern versions of bricolage or tactics. Barthes (2009) suggests that by invoking myths we fill our ideas with more expansive ambiguity and thus move from knowing facts to sensing wider patterns. In this way, engaging with the wisdom of mētis may help us unlearn our dependence on light, clarity and conceptual grasp and perhaps, allow for a re-evaluation of the importance of oblique forms of action military and business life (Freedman, 2013).
In working on this topic, we found ourselves continually surprised by the complexity of thought entailed in the Theogony, and how much it related to our observations and experiences of 'real' organizational life. In line with extant work on mythology in organization studies (Gabriel and Connell, 2010;Musson, et al., 2007), we suggest that myths hold much potential to invoke aspects which are deeply characteristic of human behavior, point towards opaque and unclear aspects of life (Gabriel, 2004), and thus resonate with us in a way which more 'direct' approaches cannot. In myths we can recognize many of our human "experiences, worries and discoveries" (Bowles, 1989;Gabriel, 2004), and as a hermeneutic device mythological narratives can indirectly convey profound messages, providing us with an avenue for personal exploration and learning.


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Computer Science
Medicine

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Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance

Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost of conducting less essential and unnecessary protocol procedures and of implementing amendments to protocol designs. Indirect costs including personnel time, work load and cycle time delays associated with complex protocol designs are also discussed. The author concludes with an overview of steps that research sponsors are taking to improve protocol design feasibility.

Introduction
Research and Development leaders widely agree that among the many factors that drive the high and rising cost of drug development, one of the most significant is protocol design [1]. As the blueprint articulating project strategy and directing project execution performed by both internal and external personnel, protocol design is uniquely positioned to fundamentally and directly impact-positively or negatively-drug development efficiency and economics.
Protocol design has historically been the domain of clinical research scientists. Under a resource-rich R&D operating environment, the regulatory approval of safe and effective medical products was the OPEN ACCESS primary test for assessing study design quality. In the current resource-constrained operating environment, a primary test of quality study design seeks to exclude any protocol that substantially wastes scarce resources, gathers extraneous data, and exposes study subjects to unnecessary risk.
Making matters worse, in the current environment, a rising number of stakeholders influence protocol design practice and quality. Not only are scientists, regulatory agencies, health authorities, operating managers and key opinion leaders informing study design decision making, but also patients/patient organizations, investigative site personnel, health care providers, policymakers and payers are increasingly playing a role.
Interviews conducted among drug development executives suggest a number of considerations and pressures that protocol design decision-making must accommodate: New scientific understanding about chronic disease mechanisms and how to measure their progression and economic impact requires collecting more clinical data. Crowded classes of experimental therapies and the ongoing movement to develop stratified medicines compel research sponsors to collect more genetic and biomarker data.
Clinical scientists and statisticians often add procedures to gather more contextual data to aid in their interpretation of the findings and to guide development decisions. Clinical teams are now collecting biomarker data, genetic material, data on economic and therapeutic outcomes, and companion diagnostic data.
Clinical teams routinely add procedures guided by the belief that the marginal cost of doing so, relative to the entire clinical study budget, is small when the risk of not doing so is high [1,2]. Additional clinical data is collected as a precautionary measure in the event that a study fails to meet its primary and key secondary objectives. Data from these procedures may prove valuable in post-hoc analyses that reveal new and useful information about the progression of disease, its treatment and new directions for future development activity. Clinical teams add procedures for fear that they may neglect to collect data requested by regulatory agencies and health authorities, purchasers and payers. Failure to collect requested data elements could potentially delay regulatory submission, product launch and product adoption. And medical writers and protocol authors also often permit outdated and unnecessary procedures into new study designs because they are routinely included in legacy protocol authoring templates and operating policies.
Collectively, these factors have all contributed to the dramatic increase in protocol design complexity during the past decade. Research conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD, Boston, MA, USA) documents this alarming trend (see Table 1) and characterizes rising levels of scientific complexity (e.g., number of endpoints; number of procedures performed; number of study volunteer eligibility criteria) and operating complexity (e.g., number of countries where clinical trials are conducted; number of investigative sites activated and monitored; number of patients screened and enrolled).
In 2012, to demonstrate safety and efficacy, a typical phase III protocol had 170 procedures on average performed on each study volunteer during the course of 11 visits across an average 230-day time span. Ten years ago, the typical phase III protocol had an average of 106 procedures, nine visits and an average 187-day time span. For the typical phase III protocol conducted in 2012, study volunteers came from an average of 34 countries and 196 research centers, up from 11 countries and 124 research centers ten years ago. And in 2012, to qualify to participate in a typical phase III protocol, each volunteer had to meet 50 eligibility criteria --up from an average of 31 inclusion and exclusion criteria ten years ago [1]. In an effort to reign in rising drug development costs, a growing number of pharmaceutical and biotechnology companies are looking to identify protocol design practices that can be modified. This article reviews two major Tufts CSDD studies that have quantified the direct cost impact of protocol design practices. This article also summarizes growing knowledge of the impact of protocol design complexity on indirect costs. At the conclusion of the article, steps that drug developers are taking to simplify protocol design and lower overall study costs are discussed.

Protocol Procedures
In a study completed in 2012, Tufts CSDD demonstrated that the cost of adding multiple individual protocol procedures, in the aggregate, is substantial. Fifteen mid-sized and large pharmaceutical and biotechnology companies participated in the study. Each company provided data on their phase II and III protocols targeting diseases across multiple therapeutic areas and executed by investigative sites dispersed globally since 2009. To minimize unusual and atypical designs, pediatric, medical device, orphan drug and extension studies were excluded from the sampling frame. In all, 116 unique phase II and III protocols having at least one procedure tied to a primary endpoint were analyzed [2].
Participating companies classified each protocol procedure according to the objective and endpoint it supported as defined by the clinical study report (CSR) and the study's specific statistical analysis plan (SAP) along the following lines: 1. "Core" procedures-supported primary and/or secondary study objectives or primary or key secondary and safety endpoints. 2. "Required" procedures-supported screening requirements and compliance-related activity including drug dispensing, informed consent form review, and study drug return. 3. "Standard" procedures-are commonly performed during initial and routine study participant visits including medical history, height and weight measurement, adverse event assessment, and concomitant medication review.
4. "Non-Core" procedures-supported supplemental secondary, tertiary and exploratory endpoints, and safety and efficacy procedures not associated with a study endpoint or objective.
Participating companies classified 25,103 individual phase II and III protocol procedures. Direct cost data for 16,607 procedures was analyzed using Medidata Solutions PICAS  database. Overall, half of the total procedures per protocol were classified as "Core" to the study. Wide variability in the incidence of procedures supporting endpoint classifications was observed across therapeutic areas. Protocols targeting endocrine and central nervous system (CNS) disorders contained a higher relative average number of procedures supporting supplementary, tertiary, and exploratory procedures (e.g., "Non-Core") endpoints. Oncology protocols had the highest relative proportion of procedures supporting "Core" endpoints and objectives, and the lowest relative proportion supporting "Non-Core" endpoints.
The distribution of direct costs was similar to that of categorized procedures: Overall, 47.9% of the total study budget on average was spent on the direct costs to administer "Core" procedures in phase II and phase III protocols. The direct cost to administer "Required" (regulatory compliance) and "Standard" procedures for phase III protocols was 22.7% and 12.0% of the study budget respectively.
For phase III protocols alone, approximately half of the total direct cost (46.7%) was spent to administer "Core" procedures; 18.6% on average was spent to administer "Non-Core" procedures; 22.7% to administer procedures supporting screening requirements and regulatory compliance; and 12% supported "Standard" procedures (See Table 2). One out of five (22.1%) phase II and III protocol procedures, on average, supported tertiary and exploratory objectives and endpoints. The proportion of procedures collecting non-core data in phase III studies alone was even higher (24.7%). Non-core procedures consumed on average 19% of total direct costs for each phase III study, and 13% of total direct costs for each phase II study [2].
The estimated total cost to the pharmaceutical industry each year to perform procedures supporting "Non-Core" objectives and endpoints for all FDA-regulated phase II and III protocols is an estimated $4-$6 billion USD. This estimate is very conservative as it excludes all indirect costs for personnel and infrastructure required to capture, monitor, clean, analyze, manage and store extraneous protocol data and it does not include any estimate for the unnecessary risk to which patients may be exposed.

Protocol Amendments
A second Tufts CSDD study showed that the incidence of protocol amendments rises with an increase in protocol design complexity. Amendments that are implemented after protocols have been approved are commonplace, but they are widely viewed as a nuisance, resulting in unplanned study delays and additional costs. Although clinical research professionals view protocol amendments as major problems, it is perhaps more accurate to view amendments as attempts to address underlying protocol design problems and external factors impacting design strategies.
Conducted in 2010, Tufts CSDD convened a group of seventeen mid-sized and large pharmaceutical and biotechnology companies each of whom provided protocol amendment data from 3,410 protocols approved between January 2006 and December 2008. The protocols were representative of multiple therapeutic areas. Protocols approved within the most recent 12-months were excluded from the study because these had not had enough time to accumulate amendments [3].
Amendments were defined as any change to a protocol requiring internal approval followed by approval from the Institutional Review Board (IRB), Ethical Review Board (ERB) or regulatory authority. Detailed data on 3,596 amendments containing 19,345 total protocol modifications was analyzed. Companies participating in this study assigned specific changes made per amendment yielding a total of 6,855 changes classified. Companies also provided the top causes for amendments and rated each amendment in terms of whether it was "Completely Avoidable", "Somewhat Avoidable", "Somewhat Unavoidable" or "Completely Unavoidable".
Nearly all protocols required at least one amendment. Completed protocols across all phases had an average of 2.3 amendments, though later-stage phase II and III protocols averaged 2.7 and 3.5 amendments respectively. Each amendment required an average of 6.9 changes to the protocol. Therapeutic areas that had the highest incidence of amendments and changes per amendment included cardiovascular and GI protocols (See Table 3). Of the 6,855 changes categorized, 16% were modifications made to the description and eligibility criteria of the patient population under investigation; 12% were adjustments made in the number and types of safety assessment procedures; 10% were edits and revisions made to the general information contained in the protocol (e.g., protocol title and study staff contact information).
Nearly 40% of all amendments occurred before the first study volunteer received his or her first dose in the clinical trial. This was most pronounced in phase I studies where 52% of amendments occurred prior to beginning patient enrollment. In phase II, III, and IIIb/IV studies, 37%, 30%, and 38% of amendments occurred before first patient first dose, respectively (see Figure 1). The most common cause of amendments was the availability of new safety information (20%), followed by requests from regulatory agencies to amend the study (19%) and changes in the study strategy (18%). Protocol design flaws and difficulties recruiting study volunteers were also top cited causes at 11% and 9% of categorized amendments, respectively.
Two-thirds (63%) of amendments had causes that sponsor companies considered unavoidable, including amendments that were the result of new safety information, new regulatory requests, changes in the standard of care or study objectives. Nearly one-out-of-four protocol amendments (37%) was considered partially or completely avoidable.
Based on data provided by participating companies, on average the direct cost to implement (i.e., first patient resubmitted under the revised protocol) a single protocol amendment is approximately $500,000 (USD) in unplanned expense and adds 61 days to the project timeline. This figure undercounts the full economic impact as it does not include the cost of internal staff time dedicated to implementing each amendment, costs or fees associated with protocol language translation, and costs associated with resubmission to the local authority.
Tufts CSDD estimates that the total cost for sponsors to implement "avoidable" protocol amendments in 2014 was approximately $2 billion (USD). This estimate is based on the incidence of amendments by phase for all active global FDA regulated clinical trials as reported by the agency; the direct cost to implement each amendment; and the proportion of amendments that is avoidable. This estimate does not include the billions of dollars realized annually in aggregate time-savings and earlier commercialization due to the elimination of each avoidable amendment [3].
To date, Tufts CSDD research on the direct cost impact of protocol design complexity has focused on non-core procedures. Tufts CSDD is currently conducting research looking at the direct cost of Core, Required and Standard procedures.

Indirect Costs
Tufts CSDD research is only beginning to quantify the indirect costs associated with protocol design complexity. These costs are no doubt many magnitudes higher than their estimated direct costs and include increasing cycle time and delays; full-and part-time staffing costs associated with project management and oversight, protocol administration and the gathering, monitoring, collecting, cleaning, analyzing, maintaining and storing of clinical data.

Cycle Time
Research published in peer-reviewed and trade literature shows a very clear relationship between study design complexity and performance: Study designs that include a relatively large number of eligibility requirements and unique procedures conducted frequently have lower study volunteer recruitment and retention rates, take longer, and generate lower quality clinical data than designs without such features [4].
Tufts CSDD research has demonstrated that the average overall duration of clinical trials-from "Protocol Ready" to the last patient completing her last visit-is 74% longer for complex clinical trials. And whereas three-out-of-four volunteers are randomized following screening and two-thirds of volunteers complete simpler protocols; 59% are randomized and less than half (48%) complete complex protocols [4].
Other studies in the literature corroborate these findings and provide insights into causes of cycle time delays [5][6][7][8][9]. Clark found, for example, that the collection of excessive and unnecessary clinical data is driving longer study durations. The author warned that data collection and regulatory agency submission delays may ultimately harm regulatory approval rates [5].
Ross and colleagues conducted a comprehensive analysis of peer-reviewed academic studies and found that health professionals were less likely to refer, and patients less likely to participate in, more complex clinical trials [6]. Madsen showed that patients are significantly less likely to sign the informed consent form when facing a more demanding protocol design [7].
In a study conducted by Boericke and Gwinn, the higher the number of study eligibility criteria, the more frequent and longer were the delays in completing clinical studies [8]. Andersen and colleagues showed that volunteer drop-out rates are much higher among patients participating in more complex clinical trials. The authors cautioned that when volunteers terminate their participation early and are lost to follow-up, the validity of the study results may be compromised [9].

Investigative Site Work Burden
Rising protocol design complexity also places additional execution burden on study staff. Work burden to administer protocol procedures was assessed using an approach developed by Tufts CSDD in 2008 and adapted from Medicare's Relative Value Unit (RVU) methodology [4]. The RVU scale was created by the Federal government in 1982 to determine reimbursement payment levels for physicians' relative costs instead of prevailing charges for medical procedures. Tufts CSDD mapped medical procedure RVUs to clinical trial procedures to derive Work Effort Units (WEU) per protocol procedure. For procedures that were not already assigned a Medicare RVU, a panel of 10 physicians at the Tufts University School of Medicine was convened to estimate the time spent per protocol procedure. "Investigative Site Work Burden" is the product of WEUs per procedure and the frequency of the procedures that were conducted over the course of the protocol.
Total investigative site work burden to administer phase II protocol procedures grew the fastest-73%-during the ten year period 2002 to 2012 outpacing growth in the total number of procedures performed per protocol. The work effort required of site personnel to administer procedures supporting phase I, III and IV protocols increased 48%, 56% and 57% during the same ten year period respectively (see Figure 2). Protocols targeting diseases associated with immunomodulation, oncology, CNS, and cardiovascular required the highest work effort from investigative site personnel to administer.

Study Monitoring, Data Management and Logistics Costs
Tufts CSDD studies have only just started to develop methodologies to measure the incremental indirect costs supporting study monitoring activity, data management and study logistics associated with complex protocol designs. In a preliminary analysis of regulatory submissions from nine major pharmaceutical companies, Tufts CSDD found that the average NDA in 1997 was nearly 70,000 pages in length and required 2 gigabytes of memory to store electronically. In 2012, the average NDA was almost 3.5 million pages and required 100 gigabytes of digital memory [10]. According to research from Medidata Solutions, a typical Phase III study collected nearly 1 million clinical data points in 2012, up from an estimated half that level 10 years ago [1].
Studies in the literature describe the impact of collecting too much data. Friedman and colleagues report that the high volume of data collected in today's protocols distracts research scientists, compromises the data analysis process and ultimately harms data quality [11]. As more data is collected during protocol administration, error rates increase, according to Nahm et al. [12]. Barrett found that more procedures per protocol were associated with a higher incidence of unused  [13]. Abrams et al. found that unused clinical data compromises the data analysis process [14]. Preliminary results from a 2014 Tufts CSDD study suggest that study monitors perform 100% source data verification on clinical data gathered from all non-core procedures and that one-third of all queries per case report form are associated with these less essential procedures.
As mentioned earlier, Tufts CSDD research indicates that the number of countries and investigative sites where clinical trials are conducted has grown considerably. As clinical trials have become more globally dispersed, research sponsors have introduced numerous logistical complexities including delivering clinical supplies and collecting lab data from more remote locations; interacting with multiple regulatory agencies and health authorities; monitoring and overseeing sites in remote locations where infrastructure is more variable.

Steps to Optimize Study Design
During the past several years, a growing number of organizations have taken the initial steps of diagnosing their protocol design practices and comparing them with industry benchmarks. Sponsor organizations have referred to published data in peer-reviewed papers to compare internal study design practices with benchmarks. Commercially available software and consulting services are also available to assist sponsor companies in assessing the problem and implementing new practices to streamline and simplify study design [1].
In addition to diagnosing the problem, sponsor organizations are looking for ways to ensure that protocol feasibility is conducted more effectively. Whereas the scientific objectives solely dictated study design elements in the past, in an environment where resources and capital are far more limited, operating objectives now carry substantially more influence over design decisions. As such, the primary objective in optimizing protocol design is to perform great science that can be feasibly and cost-effectively executed.
Many sponsor organizations now solicit feedback from principal investigators, study coordinators and from patients to identify areas where study design feasibility can be improved prior to final approval of the protocol. Some of these feedback mechanisms are conducted as in-person meetings and focus groups while others are conducted online using social and digital media communities [15].
Protocol authoring practices received a valuable new reference resource in 2013. A group of international study design stakeholders issued a collection of checklists and guidelines designed to ensure that the purpose of protocol procedures are transparent and tied to core objectives and endpoints. The SPIRIT checklist was developed with input from 115 multi-disciplinary contributors from medical writing, journal editors, regulatory agencies, ethics committees, clinical research and health care professionals.
The SPIRIT 2013 checklist and guidelines call for simple, minimalist designs that are clearly tied to core endpoints and objectives as defined by the clinical study report. Formatting conventions for various protocol elements (e.g., table of contents, glossary of terms, abbreviated terms) are also provided. The SPIRIT checklist has been pilot tested and can be downloaded for free [16].
A 2013 Tufts CSDD study documented the creation of internal governance committees charged with challenging clinical teams to improve protocol feasibility [1]. Pharmaceutical and biotechnology companies began establishing these committees 24 months ago in an effort to adopt a more systematic and long-term approach to optimizing study design. Committees are positioned within their respective organizations as objective governance and assessment mechanisms, offering guidance and input into the existing protocol review process without requiring organizations to alter legacy study design practices and procedures.
The committees raise clinical team awareness of the impact that design decisions have on study budgets and on study execution feasibility. Committees typically provide input into the study design just prior to final protocol approval and they routinely offer insight into how protocol designs can be streamlined and better "fit to purpose". Long term, internal facilitation committees may assist organizations in fundamentally improving their study design practices.
Nearly all of the facilitation committees are comprised of cross-functional representatives who volunteer their time. Committees representatives come from a variety of functions including clinical development; clinical operations; statistics; data management; medical writing; clinical pharmacology; regulatory; safety; and pharmacovigilance in addition to finance and/or procurement. Although some committees have more expansive goals than do others, all committees are charged with simplifying and streamlining protocols by reducing unnecessary procedures and the number of amendments. To meet these goals, committees assess the direct cost to perform non-core procedures and core procedures that may be conducted more frequently than necessary.
Adaptive trial designs represent an optimization opportunity that has received limited attention from research sponsors to date. Adaptive trial designs are preplanned, typically through the use of trial simulations and scenario planning where one or more specified clinical trial design elements are modified and adjusted-while the trial is underway-based on an analysis of interim data.
Tufts CSDD estimates that approximately one out of five (20%) late stage clinical trials are using a simple adaptive design approach. A much lower percentage-5%-is using more sophisticated adaptations (adaptive dose range studies and seamless phase II-III studies). Sponsor companies report that they expect the adoption of adaptive trial designs in earlier exploratory phase clinical trials to increase significantly over the next several years [17].
Study terminations due to safety and/or efficacy futility are the most common simple adaptive design used and they are more widely used at this time. Sponsor companies have found that early terminations due to futility are relatively easy to implement and a growing number of companies similarly view studies employing sample size re-estimation adaptations.
Although the concept of adaptive trial designs has been widely discussed for more than ten years, adoption has been slow for a variety of reasons. Internal organizational resistance appears to be the primary factor limiting more widespread adoption [17]. Based on interviews with company executives, regulatory agency receptivity to the use of adaptive trial designs does not appear to be as significant a barrier to adoption though agency clarity with regard to its position on the use of adaptive designs appears to be lacking.
Clinical teams and operating functions perceive enrollment and logistical factors-specifically delays and disruptions in trial execution, patient participation and distribution of clinical supplies-as major barriers to adoption. Sponsors are also concerned about introducing bias following interim analyses; the lack of adaptive trial design experience among both internal development teams and external contract research organizations; gaps in infrastructure and technology to implement more sophisticated adaptive designs; and the limited capacity of independent data monitoring committees.
Adaptive trial designs hold promise in optimizing study design. Early study terminations due to futility and sample size re-estimation could save up to a hundred million dollars (USD) in direct and indirect costs annually per pharmaceutical company depending on clinical trial scope, when the trial is actually terminated, and on the sponsor's overall implementation of this adaptive approach across the development portfolio. Perhaps the greatest impact from adaptive trial designs will come from improvements in late stage success rates. Even modest improvements in success rates for new molecular entities (NME) and new biologic entities (BME) represent billions of dollars in increased revenue potential for research sponsors.
In the immediate term, adaptive trial designs are offering cross-functional teams direct insights into study design through scenario planning and trial simulation prior to finalizing the protocol. Rigorous upfront planning-similar to optimization practices for traditional study designs-is forcing organizations to challenge protocol feasibility prior to placing the protocol in the clinic.

Conclusions
Protocol design holds the key to fundamentally and sustainably transforming drug development performance, cost and success. Research conducted by Tufts CSDD and others contributes to our growing understanding of specific opportunities that can be implemented to optimize protocol design. There is no question that pharmaceutical and biotechnology companies will adopt and implement new approaches to test and modify study design feasibility with the goal of best executing excellent science. More flexible and adaptive trial designs are expected to play a growing role in helping to optimize study design by compelling sponsor companies to perform more rigorous upfront planning and simulation and to implement preplanned adaptions that may lower fixed operating costs and ultimately improve program success rates.