Why are clinical trials so expensive? Tales from the beast’s belly
Why are things this way?  <i>cowardice</i><p>So many things in this story, and in corporate life in general, arise from fear and selfishness and shortsightedness, which take many forms.  The process of bidding, and proposals, and counterbidding described here, the meetings and trade studies and boilerplate text, are CYA efforts.  They aren&#x27;t there to help you make the right decision.  They&#x27;re there to prove you did everything anybody reasonably could be expected to do, to make the right decision.  Every coward who passes through the process raises that CYA line of reasonability a little higher.<p>The inefficiencies that no one fixes are mutually supporting; in a project this size, a little inefficiency doesn&#x27;t matter, never mind that it&#x27;s the whole pile of them that makes the project this size.  Fixing something is risky and difficult and you may break something and you don&#x27;t get anything for it.  Going along works. Is there an order of magnitude worth of bloat that can be trimmed here?  Shoot, maybe two.  But is there any gain in doing that?  Would a bid an order of magnitude (or two!) too small even be taken seriously?  If anything, such a bid would be a negative thing -- if it didn&#x27;t work out, for whatever reason, it would be easy to accuse the guy who went with the cheapest bidder.<p>To say &quot;I personally reviewed this process, and I am willing to say, on my own judgement, that it&#x27;s good&quot; takes an almost unbelievable level of courage, in a world so ready and willing to judge you for any mistake.  And yet, people doing exactly that is the only reasonable solution.  The only thing that will make good sense prevail is people standing up for good sense.  It is the only thing that can possibly prevent... this.<p>It isn&#x27;t just medicine.  It&#x27;s every industry.  It&#x27;s every community.  It&#x27;s politics writ large and HOAs writ small. I guarantee, where you work, in your own back yard, you can find examples of this problem.  The substitution of the system for the hard work of understanding and the courage to say what you think and see.  CYA over common sense.<p>What should be done?<p>The first thing to realize is that the fear that motivates this behavior is entirely justified.  People who start revolutions get shot at.  It&#x27;s a fact as old as history.  Look, in the world of nutrition, at people like Atkins and Taubes, who were ridiculed and ostracized for years before their ideas became mainstream.  Gary Fettke got into legal trouble.  That can absolutely happen to you, for nothing more than advocating an unconventional view on what you believe are solid, perhaps even scientific, grounds. (Pardon the example if you don&#x27;t agree with these folks -- the fact remains that for each of them, the personal cost of telling the truth as they saw it, and trying to fix something they thought was broken, was, at least temporarily, high.)<p>But the second thing to realize is that the fear that motivates this behavior is largely unjustified.  If you try to make things better, people usually appreciate it and try to help.  Sometimes the resistance you&#x27;re so worried about doesn&#x27;t exist.  And when it does exist, it&#x27;s often weaker than you might expect.<p>Two contradicting realizations?  Consider the case of Martin Luther King Jr., whose case was basic, and obviously moral, and inspiring, and who nonetheless had every reasonable thing to fear--whose enemies were absolutely real, and dangerous, and persecuted and ultimately killed him (point 1!), but who was also taking on the absolutely massive and invincible dragon of the generations-entrenched psychological direction of an <i>entire</i> <i>massive</i> <i>country</i>, and who substantially <i>won</i> that fight! (point 2)<p>Do you want to change medicine?<p>Look at Dr. Garrison Bliss, a primary care physician who hated the way primary care was done, figured out how to do it another way, and started a movement in which I-don&#x27;t-know-how-many-thousands-maybe-millions of people get to do it that better way.<p>Look at Dr. Jason Fung, a doctor who chased a &quot;what if&quot; curiosity about type 2 diabetes right into a revolution that is right now on the edge of saving millions upon millions of people.<p>These guys could easily have gotten run over by the massive industries they were taking on, but for one reason or another, they just . . . did what they thought was right, and the worst just . . . never happened.<p>Stepping away from medicine for a moment, do you know what else used to be this way?  Taxis.  I remember back when there were never enough taxis, and you had to wait for them for a long time, and they were so expensive and unpleasant that it was a running joke in pop culture.  For the same basket of reasons -- corruption and cowardice and short-sightedness and selfishness and not my problem.  And you know, when Uber started to change it, they were <i>definitely</i> maybe doing something illegal in a lot of places.  Were they going to get legally slammed for it?  I sometimes wondered.  But the laws obviously made the world a worse place, and the alternative was so <i>nice</i> by comparison, and here we are -- in a world which still has its problems, but obscenely, irrationally, how-did-it-ever-get-this-bad taxi service isn&#x27;t one of them.<p>It&#x27;s not your job to fix the world.  (And it turns out that even if you <i>did</i> become dictator-for-life, fixing the world would remain surprisingly hard and require surprisingly many of the same character traits -- so there is no point in waiting for official permission.)  It&#x27;s not your job to fix medicine.  It&#x27;s not your job to fix education.  It <i>is</i> your job to fix what&#x27;s right in front of you.  Want to be the SpaceEX of CROs?  Sure sounds like <i>somebody</i> can.  Maybe it&#x27;s you.  Too big?  Fix your own clinical trial.  Too big?  Fix some of the inefficiencies.  I&#x27;m glad you tried to fix the meeting thing.  Keep trying.  Fix <i>one</i> meeting.<p>PG&#x27;s advice about startups -- &quot;just don&#x27;t quit&quot; -- is surprisingly apropos to any revolution.  It seems black and impossible right up until it doesn&#x27;t anymore. If you find something important enough to be <i>worth</i> that to you, and if you just keep swimming, if you don&#x27;t give up and constantly pivot to trying something new when you find the way blocked, constantly figure out what to <i>do</i> about problems, it&#x27;s astonishing what one person can accomplish.<p>You may die in the process.  In the fifteenth and sixteenth century, the Catholic Church was in this place -- corrupt and ineffective and unbelievably powerful and invincible and had been ruling the world for literally hundreds of years. Enough people laughed at it and hated it for it to be a running cultural joke: the fat monks and corrupt bishops of Robin Hood are exactly this joke, and the story is about how an outlaw can obviously be the better person.  The story is about exactly this problem, and it was popular in the 15th century because that was what was on everyone&#x27;s mind!  And yet even such story did not propose a solution.  It settled for talking about the problem.  There were no solutions. 
 Alternatives were unthinkable. Every now and again, someone would try what I recommend, they&#x27;d try to fix their little piece and make things better, and they&#x27;d be crushed by the great power and die and fail.  Nobody knew Tyndale would be different -- and all he was trying to do was get better knowledge to more people.  Nobody knew Luther would be different -- all he was trying to do was start a debate and get some theological reform.  Their ambitions were small, and people before them had died both for less and for the exact same things, and the fact that they tried anyway is why they were able to succeed, and why we have the world we have today. (Pardon the example if you don&#x27;t see this particular history this way -- you can find other examples where many failures preceded success, where fears are justified, and yet where taking that chance results in slaying absurdly powerful dragons.)<p>I myself am convinced that someone like that, doing something like that, is the only reason we ever have any nice things at all.  The CYA process sure isn&#x27;t producing them, I can tell you that much for sure!  And so to answer the question of &quot;Why things are this way&quot;, well -- in that particular corner of the world, nobody ever did <i>that</i>.  What&#x27;s to be done?  Do it. :)