Understanding the Barriers to Clinical Trial Referral and Enrollment Among Oncology Providers Within the Veterans Health Administration
Clinical trials are critical for the advancement of scientific knowledge, development of new treatments, and provision of access to innovative treatment options not yet available via standard care. Clinical trials are particularly important in cancer, given the impact on morbidity and mortality. However, only 2 to 8% of cancer patients in the United States participate in clinical trials. Among the Veteran population, trial participation is likely even lower. Disproportionately low participation rates among groups underrepresented in clinical trials, including racial and ethnic minoritized groups, individuals who are older, those who suffer from comorbidities, those who live in rural areas, and those who have lower income, may perpetuate disparities in treatment outcomes. Limited enrollment rates do not seem to be predominantly the result of patients’ attitudes or lack of willingness, including among Veterans, who may want to serve future patients like themselves. Rather, barriers often exist at multiple levels and include the unavailability of trials for many specific cancer types and stages, strict inclusion/exclusion criteria, a lack of clinical trial support, inadequate staffing, , , financial constraints, , , and issues related to trial location accessibility, particularly for elderly and rural populations. , Research also suggests that patients heavily rely on physicians for information about available treatment options and physicians are generally supportive to clinical trials. , However, studies indicate that their preconceptions about patients’ beliefs, hesitations, and abilities to adhere to the trial protocol, coupled with limited awareness of available trials, may negatively influence their decision to introduce clinical trials as a treatment option. , Although extant literature explores these barriers among the general cancer population and various health care settings, barriers in the specific context of the Veterans Health Administration (VHA) remain largely unexamined. Focusing on the VHA is important: as the largest integrated health care system in the United States and a leading provider of oncology services, it offers comprehensive medical care for over 450,000 Veterans with cancer, diagnosing 43,000 new cases annually. Initiatives such as the National Cancer Institute (NCI) and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE) program and VHA work on the White House Cancer Moonshot are crucial for increasing Veterans’ opportunities to participate in clinical trials; however, further research is needed to understand the multifaceted challenges underlying limited enrollment for Veterans who receive care in the VHA system. The present study had 2 aims: first, to investigate the barriers to and potential facilitators of clinical trial referral and enrollment in the VHA from the perspective of health care providers and, second, to understand the steps and decision points that VHA providers move through when deciding to refer a patient to a clinical trial. The results were intended to inform actions that the VHA could potentially take to improve Veterans’ access to clinical trials. 

This study was conducted using a mixed-methods approach, including a quantitative descriptive design consisting of an electronic survey and a qualitative descriptive design comprising semistructured interviews, between May 2022 and August 2023. Because the purpose of this study was to improve the quality of care for Veterans, VHA IRB review and approval were not required. Survey Based on the existing literature, researchers developed an electronic 34-item survey to capture VHA oncology care providers’ perceptions of and experiences with referral and enrollment to clinical trials. The survey topics included the following actions taken when deciding to refer a patient to a clinical trial; motivations for and barriers to referring and enrolling patients in clinical trials; efficacy of tools and strategies to improve the referral and enrollment processes; providers’ concerns and perceived patient concerns; providers’ experiences in finding and discussing clinical trials with patients; and respondent sociodemographics. To be eligible to participate in the survey, VHA oncology providers had to be staff physicians, residents, fellows, advanced practice providers (nurse practitoners [NPs] and physician assistants [PA] ), or nurses. This research project was introduced to VHA oncology providers via a presentation at a session of the VHA Oncology Office Hours. Individuals who attended this session subsequently received the survey link via email and 1 follow-up reminder. In addition, the survey was distributed to an email list of 1,300 VA oncology staff, which included physicians, advanced practice providers, and nurses, as well as other types of staff. Semistructured Interviews At the end of the survey, respondents were asked whether they would be willing to participate in a follow-up conversation to discuss their experiences with clinical trials further. Interview eligibility was limited to VHA oncology providers who were staff physicians, fellows, or advanced practice providers. Fifteen providers responded positively and were invited via email to participate in a semistructured interview; 3 of these individuals responded to interview request emails and agreed to participate. The remaining 5 interview respondents were recruited by the 2 VHA authors. The semistructured interview guide was developed based on the existing literature that explored providers’ perceived barriers to clinical trial participation , , and recruitment bias. Interviews inquired about potentially modifiable factors for improving clinical trial enrollment at the VHA, such as providers’ concerns, motivations for and facilitators of enrolling patients into clinical trials, and the manner in which providers communicate about clinical trials with their patients. Interviews were conducted remotely and recorded. Analysis Thematic analysis was performed using MAXQDA 2022 (VERBI Software, 2021). Three researchers coded 3 transcripts and met to compare and discuss codes until consensus was reached to develop a set of codes that guided the remaining interviews’ coding. Theme identification followed an inductive approach; themes were identified, and the number of providers who reported each theme was recorded. Themes presented in this study were reported by at least 5 providers. 

Based on the existing literature, researchers developed an electronic 34-item survey to capture VHA oncology care providers’ perceptions of and experiences with referral and enrollment to clinical trials. The survey topics included the following actions taken when deciding to refer a patient to a clinical trial; motivations for and barriers to referring and enrolling patients in clinical trials; efficacy of tools and strategies to improve the referral and enrollment processes; providers’ concerns and perceived patient concerns; providers’ experiences in finding and discussing clinical trials with patients; and respondent sociodemographics. To be eligible to participate in the survey, VHA oncology providers had to be staff physicians, residents, fellows, advanced practice providers (nurse practitoners [NPs] and physician assistants [PA] ), or nurses. This research project was introduced to VHA oncology providers via a presentation at a session of the VHA Oncology Office Hours. Individuals who attended this session subsequently received the survey link via email and 1 follow-up reminder. In addition, the survey was distributed to an email list of 1,300 VA oncology staff, which included physicians, advanced practice providers, and nurses, as well as other types of staff. 

At the end of the survey, respondents were asked whether they would be willing to participate in a follow-up conversation to discuss their experiences with clinical trials further. Interview eligibility was limited to VHA oncology providers who were staff physicians, fellows, or advanced practice providers. Fifteen providers responded positively and were invited via email to participate in a semistructured interview; 3 of these individuals responded to interview request emails and agreed to participate. The remaining 5 interview respondents were recruited by the 2 VHA authors. The semistructured interview guide was developed based on the existing literature that explored providers’ perceived barriers to clinical trial participation , , and recruitment bias. Interviews inquired about potentially modifiable factors for improving clinical trial enrollment at the VHA, such as providers’ concerns, motivations for and facilitators of enrolling patients into clinical trials, and the manner in which providers communicate about clinical trials with their patients. Interviews were conducted remotely and recorded. 

Thematic analysis was performed using MAXQDA 2022 (VERBI Software, 2021). Three researchers coded 3 transcripts and met to compare and discuss codes until consensus was reached to develop a set of codes that guided the remaining interviews’ coding. Theme identification followed an inductive approach; themes were identified, and the number of providers who reported each theme was recorded. Themes presented in this study were reported by at least 5 providers. 

Forty-six survey responses were recorded using Qualtrics; however, 8 respondents did not complete any survey items. Ultimately, 38 responses were included in the quantitative analyses, conducted using Stata 17 (StataCorp, 2021). Thirty-four respondents identified their specialty as medical oncology, 1 identified the specialty as radiation oncology, and 3 identified their specialty as hematology. Respondents included 27 staff physicians, 4 residents, and 3 fellows. Nineteen respondents identified as women and 14 as men; the remainder did not provide their gender. Three respondents identified as Hispanic or Latino individuals, 11 identified as Asians, 3 identified as Black individuals, and 17 identified as White individuals. Interviews were conducted with 8 VHA medical oncology providers (2 identified as male individuals and 6 identified as female individuals). Participants included 1 NP, 1 PA, 5 staff physicians, and 1 fellow. Five interview participants reported holding an individual academic affiliation. The median duration of interview was 24 min (range 17–33 min). The quantitative and qualitative study results were categorized using the following identified themes: (1) clinical trial experience and referring behavior, (2) system-level barriers, (3) institutional-level barriers, (4) provider-level barriers, (5) patient-level barriers, and 6) clinical trial referral and enrollment facilitators. Clinical Trial Experience and Referring Behavior Twenty-nine survey respondents (76%) indicated that they had previously served as a member of trial research staff involved in clinical trial design or in clinical trial enrollment. Of them, 9 (31%) indicated that they had served as a member of the research staff on a trial 1 to 5 times; 7 (24%) indicated that they had served 6 to 10 times; 5 (17%) indicated that they had served 11 to 15 times; 2 (7%) indicated that they had served 16 to 20 times; and 6 (21%) indicated that they had served as clinical trial research staff over 20 times. Thirty-three respondents (87%) indicated that they had previously referred patients to clinical trials for which they themselves were not part of the research team. When survey respondents were asked to indicate how frequently they engage in various activities related to clinical trial enrollment (response options: never [0], sometimes [1], about half the time [2], most of the time [3], and always [4]), the mean responses ranged from 1.76 to 1.95 for all activities (between sometimes and about half the time). Furthermore, participants were asked to order their selected actions to reflect the sequence of actions they typically follow when exploring the enrollment of patients onto clinical trials. Providers interviewed varied in their experience with clinical trials, with 5 participants reporting having participated in clinical trials as research staff in the past. Participants reported infrequently introducing clinical trials to their patients: “maybe 10% or less of my patients” (P1, Staff Physician). Additionally, interview participants reported enrolling “10% [of the patients they referred]” (P3, Staff Physician) or not having enrolled “any patients” in clinical trials (P4, PA). Most participants also reported considering clinical trials only when standard therapies were no longer effective. Several participants reported introducing trials as a third or fourth line of treatment or when running out of treatment options: “I would say, usually, I refer them [patients] at a state where they don’t have a lot of other choices, unfortunately” (P1, Staff Physician). System-Level Barriers Lack of trial availability and restrictive inclusion or exclusion criteria Respondents were asked to state the frequency with which they experience different concerns when considering whether to refer a patient to a clinical trial, with the response options being: never (0), sometimes (1), about half the time (2), most of the time (3), and always (4). On average, the most frequently experienced concern was “There is no appropriate trial within the VA” ( M = 2.50, SD = 1.18), falling in between “about half the time” and “most of the time.” This was followed by “The patient is unlikely to be eligible for any trials” ( M = 2.18, SD = 1.08), again falling in between “about half the time” and “most of the time” (mean values and standard deviations for all survey items are found in ). These findings are echoed by interview results, with several providers noting a scarcity of clinical trials available for their patient population, “[I rarely introduce clinical trials] due to a dearth of clinical trials available either on site or in the local area” (P3, Staff Physician), and citing the trials’ inclusion and exclusion criteria as a referral barrier, “for whatever reason, most people don’t meet the inclusion criteria” (P5, Staff Physician). Institutional-Level Barriers Unclear and complex referral processes When asked about challenges related to discussing and managing clinical trial participation, on average, respondents indicated that dealing with the extra work of the referral process for trials outside the VHA system was the most significant challenge (M = 3.44, SD = 1.46). Even though discussing clinical trials with patients and identifying local clinical trial options were indicated as relatively least challenging ( M = 2.38 and 2.32, respectively), these actions were still reported as moderately challenging. Additionally, interviewed providers reported facing administrative barriers to referring patients to clinical trials, especially if trials are conducted outside the VHA. “If there’s a service that the VA can’t provide, we’re allowed to refer out to the community, and the VA would pay for that. But if you’re trying to get someone on a trial very quickly  or they’re progressing very quickly, getting sick quickly, that process can be a barrier to getting them even across the street” (P6, Fellow). Several providers noted that the process for Community Care requests, necessary for getting patients’ coverage for non-VHA trials, is not always clear: “[S]ometimes I don’t understand the rules [of referral]” (P7, Staff Physician). Provider-Level Barriers Lack of awareness, lack of time, and challenges identifying clinical trial options Survey and interview results show that providers sometimes do not have enough information on available clinical trials. Interview participants reported lack of time as a barrier to keeping themselves informed about trial options. “We are not made aware of the current existing clinical trials that are available to the patients  I work with six or seven different doctors. And I don’t know anyone who has used a clinical trial” (P2, NP). “There’s just so much time that we need to be invested  to know everything that’s out there would be really time-consuming” (P6, Fellow). Similarly, survey participants rated a series of actions related to offering clinical trials and referring patients to participate in clinical trials on a scale of 1 (not challenging) to 5 (very challenging). On average, respondents indicated that identifying clinical trial options in other VHA sites was the most challenging action ( M = 4.21, sd = 1.10) . Identifying clinical trials outside the VHA was the second most challenging action (M = 3 0.41, sd = 1.46). Patient-Level Barriers Financial and logistical concerns Surveyed providers indicated that lack of transportation is a patient concern between most of the time and always ( M = 3.46, sd = 0.78), and a provider concern between about half the time and most of the time ( M = 2.08, sd = 0.97) . Lack of insurance was a reported concern for both patients and providers. Additionally, all interviewed providers expressed that transportation, trial treatment coverage, lodging, and/or other extra costs associated with clinical trial participation are critical barriers to clinical trial referral. Providers often reported only considering trials within driving distance. “I really think that logistics is really what drives our ability to get our patients onto trials  I think if we ironed out the logistics, we’d certainly have a higher fraction of our patients on trials” (P5, Staff Physician). “Patients are always worried about, like, well, is that going to be covered? Do I have to pay for that?” (P4, PA) Medical mistrust Surveyed providers and most interviewed providers reported medical mistrust as an important patient concern when considering clinical trial participation. Providers reported that patients often use the word “guinea pig” (P2, P3, P4, and P7) when discussing trial participation. Lack of social support and comorbidities Participants also reported that patients’ lack of social support and patients’ comorbidities are other important barriers to clinical trial participation for the Veteran population: “We do have large issues with compliance, unfortunately. […] I think a lot of our Veterans don’t have the social support to make sure that they have what they need to even get through treatment, never mind, get through a trial” (P5, Staff Physician). “There are some compliance issues, there is a fair amount of mental health concerns […] that perhaps interfere with their ability to grasp the importance of keeping their appointments, and follow-ups” (P8, Staff Physician). Potential Solutions to Encourage Clinical Trial Referrals Nurse navigators, research coordinators, and connections to academic institutions Participants were asked to consider a series of factors that could aid in discussing clinical trials with patients and to rate these items on a scale of 0 (not at all helpful) to 4 (very helpful). Veteran nurse navigators were considered the most helpful ( M = 3.47, sd = 0.96), followed by research coordinators contacting cancer teams ( M = 3.29, sd = 1.17). When presented with several proposed solutions to clinical trial referral barriers, VA oncology providers preferred involving staff who are specifically focused on the problem, rather than relying on oncology providers and their patients. This is echoed by interview findings, with participants reporting that research coordinators are key facilitators of clinical trial referral as they might “take that burden off of clinicians who are trying to do a lot of things” (P1, Staff Physician). Research coordinators might also facilitate prescreening: “What’s helped in my experience is, when we’ve had a clinical research coordinator do what’s called like a pre-screening  I think that’s a very critical step if allowed” (P3, Staff Physician). “If I was able to get a clinical research navigator  I could pre-screen Veterans,  be able to stay on top of the regulatory [work], accrue to the trials, and exchange information about our trials within our VISNs [Veterans Integrated Services Networks] as well as within our community and academic partner. So, if we had some type of a navigator, there would be a bridge between the VA and Veterans, between the VA and our staff […]” (P8, Staff Physician). Most interview participants reported that having an NCI or academic affiliation and/or some other relationship with a cancer center or medical institution was beneficial for referring patients into trials. Participants reported being aware of the advantage of holding these positions: “Outside the VA, we have both community as well as academic affiliates. And we also have affiliates within our VISNs. And so we meet very regularly, at least with the VISNs […], which helps all of us discuss different clinical trials” (P8, Staff Physician). The Referral Process A second aim of this study was to capture the complexity of the clinical trial referral process based on the survey and interview results. illustrates the identified barrier domains and their links to the different phases of clinical trial referral. It also includes key decision points and potential outcomes at each phase. 

Twenty-nine survey respondents (76%) indicated that they had previously served as a member of trial research staff involved in clinical trial design or in clinical trial enrollment. Of them, 9 (31%) indicated that they had served as a member of the research staff on a trial 1 to 5 times; 7 (24%) indicated that they had served 6 to 10 times; 5 (17%) indicated that they had served 11 to 15 times; 2 (7%) indicated that they had served 16 to 20 times; and 6 (21%) indicated that they had served as clinical trial research staff over 20 times. Thirty-three respondents (87%) indicated that they had previously referred patients to clinical trials for which they themselves were not part of the research team. When survey respondents were asked to indicate how frequently they engage in various activities related to clinical trial enrollment (response options: never [0], sometimes [1], about half the time [2], most of the time [3], and always [4]), the mean responses ranged from 1.76 to 1.95 for all activities (between sometimes and about half the time). Furthermore, participants were asked to order their selected actions to reflect the sequence of actions they typically follow when exploring the enrollment of patients onto clinical trials. Providers interviewed varied in their experience with clinical trials, with 5 participants reporting having participated in clinical trials as research staff in the past. Participants reported infrequently introducing clinical trials to their patients: “maybe 10% or less of my patients” (P1, Staff Physician). Additionally, interview participants reported enrolling “10% [of the patients they referred]” (P3, Staff Physician) or not having enrolled “any patients” in clinical trials (P4, PA). Most participants also reported considering clinical trials only when standard therapies were no longer effective. Several participants reported introducing trials as a third or fourth line of treatment or when running out of treatment options: “I would say, usually, I refer them [patients] at a state where they don’t have a lot of other choices, unfortunately” (P1, Staff Physician). 

Lack of trial availability and restrictive inclusion or exclusion criteria Respondents were asked to state the frequency with which they experience different concerns when considering whether to refer a patient to a clinical trial, with the response options being: never (0), sometimes (1), about half the time (2), most of the time (3), and always (4). On average, the most frequently experienced concern was “There is no appropriate trial within the VA” ( M = 2.50, SD = 1.18), falling in between “about half the time” and “most of the time.” This was followed by “The patient is unlikely to be eligible for any trials” ( M = 2.18, SD = 1.08), again falling in between “about half the time” and “most of the time” (mean values and standard deviations for all survey items are found in ). These findings are echoed by interview results, with several providers noting a scarcity of clinical trials available for their patient population, “[I rarely introduce clinical trials] due to a dearth of clinical trials available either on site or in the local area” (P3, Staff Physician), and citing the trials’ inclusion and exclusion criteria as a referral barrier, “for whatever reason, most people don’t meet the inclusion criteria” (P5, Staff Physician). 

Respondents were asked to state the frequency with which they experience different concerns when considering whether to refer a patient to a clinical trial, with the response options being: never (0), sometimes (1), about half the time (2), most of the time (3), and always (4). On average, the most frequently experienced concern was “There is no appropriate trial within the VA” ( M = 2.50, SD = 1.18), falling in between “about half the time” and “most of the time.” This was followed by “The patient is unlikely to be eligible for any trials” ( M = 2.18, SD = 1.08), again falling in between “about half the time” and “most of the time” (mean values and standard deviations for all survey items are found in ). These findings are echoed by interview results, with several providers noting a scarcity of clinical trials available for their patient population, “[I rarely introduce clinical trials] due to a dearth of clinical trials available either on site or in the local area” (P3, Staff Physician), and citing the trials’ inclusion and exclusion criteria as a referral barrier, “for whatever reason, most people don’t meet the inclusion criteria” (P5, Staff Physician). 

Unclear and complex referral processes When asked about challenges related to discussing and managing clinical trial participation, on average, respondents indicated that dealing with the extra work of the referral process for trials outside the VHA system was the most significant challenge (M = 3.44, SD = 1.46). Even though discussing clinical trials with patients and identifying local clinical trial options were indicated as relatively least challenging ( M = 2.38 and 2.32, respectively), these actions were still reported as moderately challenging. Additionally, interviewed providers reported facing administrative barriers to referring patients to clinical trials, especially if trials are conducted outside the VHA. “If there’s a service that the VA can’t provide, we’re allowed to refer out to the community, and the VA would pay for that. But if you’re trying to get someone on a trial very quickly  or they’re progressing very quickly, getting sick quickly, that process can be a barrier to getting them even across the street” (P6, Fellow). Several providers noted that the process for Community Care requests, necessary for getting patients’ coverage for non-VHA trials, is not always clear: “[S]ometimes I don’t understand the rules [of referral]” (P7, Staff Physician). 

When asked about challenges related to discussing and managing clinical trial participation, on average, respondents indicated that dealing with the extra work of the referral process for trials outside the VHA system was the most significant challenge (M = 3.44, SD = 1.46). Even though discussing clinical trials with patients and identifying local clinical trial options were indicated as relatively least challenging ( M = 2.38 and 2.32, respectively), these actions were still reported as moderately challenging. Additionally, interviewed providers reported facing administrative barriers to referring patients to clinical trials, especially if trials are conducted outside the VHA. “If there’s a service that the VA can’t provide, we’re allowed to refer out to the community, and the VA would pay for that. But if you’re trying to get someone on a trial very quickly  or they’re progressing very quickly, getting sick quickly, that process can be a barrier to getting them even across the street” (P6, Fellow). Several providers noted that the process for Community Care requests, necessary for getting patients’ coverage for non-VHA trials, is not always clear: “[S]ometimes I don’t understand the rules [of referral]” (P7, Staff Physician). 

Lack of awareness, lack of time, and challenges identifying clinical trial options Survey and interview results show that providers sometimes do not have enough information on available clinical trials. Interview participants reported lack of time as a barrier to keeping themselves informed about trial options. “We are not made aware of the current existing clinical trials that are available to the patients  I work with six or seven different doctors. And I don’t know anyone who has used a clinical trial” (P2, NP). “There’s just so much time that we need to be invested  to know everything that’s out there would be really time-consuming” (P6, Fellow). Similarly, survey participants rated a series of actions related to offering clinical trials and referring patients to participate in clinical trials on a scale of 1 (not challenging) to 5 (very challenging). On average, respondents indicated that identifying clinical trial options in other VHA sites was the most challenging action ( M = 4.21, sd = 1.10) . Identifying clinical trials outside the VHA was the second most challenging action (M = 3 0.41, sd = 1.46). 

Survey and interview results show that providers sometimes do not have enough information on available clinical trials. Interview participants reported lack of time as a barrier to keeping themselves informed about trial options. “We are not made aware of the current existing clinical trials that are available to the patients  I work with six or seven different doctors. And I don’t know anyone who has used a clinical trial” (P2, NP). “There’s just so much time that we need to be invested  to know everything that’s out there would be really time-consuming” (P6, Fellow). Similarly, survey participants rated a series of actions related to offering clinical trials and referring patients to participate in clinical trials on a scale of 1 (not challenging) to 5 (very challenging). On average, respondents indicated that identifying clinical trial options in other VHA sites was the most challenging action ( M = 4.21, sd = 1.10) . Identifying clinical trials outside the VHA was the second most challenging action (M = 3 0.41, sd = 1.46). 

Financial and logistical concerns Surveyed providers indicated that lack of transportation is a patient concern between most of the time and always ( M = 3.46, sd = 0.78), and a provider concern between about half the time and most of the time ( M = 2.08, sd = 0.97) . Lack of insurance was a reported concern for both patients and providers. Additionally, all interviewed providers expressed that transportation, trial treatment coverage, lodging, and/or other extra costs associated with clinical trial participation are critical barriers to clinical trial referral. Providers often reported only considering trials within driving distance. “I really think that logistics is really what drives our ability to get our patients onto trials  I think if we ironed out the logistics, we’d certainly have a higher fraction of our patients on trials” (P5, Staff Physician). “Patients are always worried about, like, well, is that going to be covered? Do I have to pay for that?” (P4, PA) Medical mistrust Surveyed providers and most interviewed providers reported medical mistrust as an important patient concern when considering clinical trial participation. Providers reported that patients often use the word “guinea pig” (P2, P3, P4, and P7) when discussing trial participation. Lack of social support and comorbidities Participants also reported that patients’ lack of social support and patients’ comorbidities are other important barriers to clinical trial participation for the Veteran population: “We do have large issues with compliance, unfortunately. […] I think a lot of our Veterans don’t have the social support to make sure that they have what they need to even get through treatment, never mind, get through a trial” (P5, Staff Physician). “There are some compliance issues, there is a fair amount of mental health concerns […] that perhaps interfere with their ability to grasp the importance of keeping their appointments, and follow-ups” (P8, Staff Physician). 

Surveyed providers indicated that lack of transportation is a patient concern between most of the time and always ( M = 3.46, sd = 0.78), and a provider concern between about half the time and most of the time ( M = 2.08, sd = 0.97) . Lack of insurance was a reported concern for both patients and providers. Additionally, all interviewed providers expressed that transportation, trial treatment coverage, lodging, and/or other extra costs associated with clinical trial participation are critical barriers to clinical trial referral. Providers often reported only considering trials within driving distance. “I really think that logistics is really what drives our ability to get our patients onto trials  I think if we ironed out the logistics, we’d certainly have a higher fraction of our patients on trials” (P5, Staff Physician). “Patients are always worried about, like, well, is that going to be covered? Do I have to pay for that?” (P4, PA) 

Surveyed providers and most interviewed providers reported medical mistrust as an important patient concern when considering clinical trial participation. Providers reported that patients often use the word “guinea pig” (P2, P3, P4, and P7) when discussing trial participation. 

Participants also reported that patients’ lack of social support and patients’ comorbidities are other important barriers to clinical trial participation for the Veteran population: “We do have large issues with compliance, unfortunately. […] I think a lot of our Veterans don’t have the social support to make sure that they have what they need to even get through treatment, never mind, get through a trial” (P5, Staff Physician). “There are some compliance issues, there is a fair amount of mental health concerns […] that perhaps interfere with their ability to grasp the importance of keeping their appointments, and follow-ups” (P8, Staff Physician). 

Nurse navigators, research coordinators, and connections to academic institutions Participants were asked to consider a series of factors that could aid in discussing clinical trials with patients and to rate these items on a scale of 0 (not at all helpful) to 4 (very helpful). Veteran nurse navigators were considered the most helpful ( M = 3.47, sd = 0.96), followed by research coordinators contacting cancer teams ( M = 3.29, sd = 1.17). When presented with several proposed solutions to clinical trial referral barriers, VA oncology providers preferred involving staff who are specifically focused on the problem, rather than relying on oncology providers and their patients. This is echoed by interview findings, with participants reporting that research coordinators are key facilitators of clinical trial referral as they might “take that burden off of clinicians who are trying to do a lot of things” (P1, Staff Physician). Research coordinators might also facilitate prescreening: “What’s helped in my experience is, when we’ve had a clinical research coordinator do what’s called like a pre-screening  I think that’s a very critical step if allowed” (P3, Staff Physician). “If I was able to get a clinical research navigator  I could pre-screen Veterans,  be able to stay on top of the regulatory [work], accrue to the trials, and exchange information about our trials within our VISNs [Veterans Integrated Services Networks] as well as within our community and academic partner. So, if we had some type of a navigator, there would be a bridge between the VA and Veterans, between the VA and our staff […]” (P8, Staff Physician). Most interview participants reported that having an NCI or academic affiliation and/or some other relationship with a cancer center or medical institution was beneficial for referring patients into trials. Participants reported being aware of the advantage of holding these positions: “Outside the VA, we have both community as well as academic affiliates. And we also have affiliates within our VISNs. And so we meet very regularly, at least with the VISNs […], which helps all of us discuss different clinical trials” (P8, Staff Physician). 

Participants were asked to consider a series of factors that could aid in discussing clinical trials with patients and to rate these items on a scale of 0 (not at all helpful) to 4 (very helpful). Veteran nurse navigators were considered the most helpful ( M = 3.47, sd = 0.96), followed by research coordinators contacting cancer teams ( M = 3.29, sd = 1.17). When presented with several proposed solutions to clinical trial referral barriers, VA oncology providers preferred involving staff who are specifically focused on the problem, rather than relying on oncology providers and their patients. This is echoed by interview findings, with participants reporting that research coordinators are key facilitators of clinical trial referral as they might “take that burden off of clinicians who are trying to do a lot of things” (P1, Staff Physician). Research coordinators might also facilitate prescreening: “What’s helped in my experience is, when we’ve had a clinical research coordinator do what’s called like a pre-screening  I think that’s a very critical step if allowed” (P3, Staff Physician). “If I was able to get a clinical research navigator  I could pre-screen Veterans,  be able to stay on top of the regulatory [work], accrue to the trials, and exchange information about our trials within our VISNs [Veterans Integrated Services Networks] as well as within our community and academic partner. So, if we had some type of a navigator, there would be a bridge between the VA and Veterans, between the VA and our staff […]” (P8, Staff Physician). Most interview participants reported that having an NCI or academic affiliation and/or some other relationship with a cancer center or medical institution was beneficial for referring patients into trials. Participants reported being aware of the advantage of holding these positions: “Outside the VA, we have both community as well as academic affiliates. And we also have affiliates within our VISNs. And so we meet very regularly, at least with the VISNs […], which helps all of us discuss different clinical trials” (P8, Staff Physician). 

A second aim of this study was to capture the complexity of the clinical trial referral process based on the survey and interview results. illustrates the identified barrier domains and their links to the different phases of clinical trial referral. It also includes key decision points and potential outcomes at each phase. 

This is the first mixed-methods research study providing insights into the perspectives of oncology providers about the clinical trial referral and enrollment process at the VHA. Providers highlighted patient-level barriers that prevent patients from being referred and enrolling in clinical trials (e.g., transportation, medical mistrust, and insurance); this is consistent with that reported in the literature. , , Also consistent with the literature, , , findings indicate that the lack of appropriate clinical trials within the VHA system and patients’ ineligibility for trials within and outside the VHA were concerns of providers. Specifically, survey respondents indicated that identifying clinical trial options in other VA sites was the most challenging action, whereas identifying clinical trials outside of the VA was the second most challenging action; this was supported by the interview data. Some providers expressed facing administrative barriers pertaining to the process of referring patients to trials outside the VHA system. Participants reported a lack of clarity regarding how the decisions to approve Community Care are made. These insights suggest that there may be value in standardizing and clarifying the procedure for referring patients to trials outside the VHA system. Results suggest that academic affiliation provides VHA providers with access to information about clinical trials that are being conducted in non-VHA research centers. Furthermore, the type and quality of this relationship, which can be at an individual or VHA facility level, may create disparities in clinicians’ access to clinical trial information: those connected to academic institutions can more easily find trials outside the VHA. Addressing clinical trial information access could potentially be a valuable way to increase clinical trial referral and enrollment at the VHA. Moreover, identifying and implementing tools and services that can expedite trial identification across and outside the VHA would be advisable. Respondents reported that research coordinators and internal and external nurse navigators could be helpful in aiding clinical trial discussions with patients and enrolling them onto trials. 

In this study, VHA oncology providers offered unique insights into the barriers and facilitators of clinical trial introduction and referral processes. Challenges include the lack of appropriate trials and patient eligibility, difficulties in dealing with the referral process for trials both inside and outside the VHA system, and patients’ financial and logistical barriers. Respondents indicated that research coordinators, internal and external nurse navigators, and academic affiliations could facilitate clinical trial discussions with patients as well as referral to and enrollment into trials. The results of this study provide insights into where resources could be allocated to help providers navigate the multistep and often challenging process of referring Veterans to clinical trials both within and outside the VHA. 

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