Clinical Researcher—October 2025 (Volume 39, Issue 5)
PEER REVIEWED
Toni J. Sokol, MS, MHA, DHSc; David A. Scalzitti, MS, PhD;
Joyce R. Maring, EdD
Clinical trials are essential for healthcare; however, recruiting participants remains a significant challenge. Primary/urgent care providers (PCPs) play a key role in supporting clinical trial recruitment. This study surveyed PCPs in Omaha, Neb. (n=49), to identify facilitators and barriers to their support of clinical trial referrals. The primary barriers identified were a lack of awareness of available trials, the absence of clinic-wide referral processes, and time constraints. Facilitators included in-clinic study presentations and electronic health record documentation of trial participation. Notably, most providers acknowledged the potential benefits of recruiting patients in primary care settings but did not view trial referrals as an integral or rewarding aspect of their role.
The findings suggest that increasing provider awareness, streamlining referral processes, and fostering a culture incorporating clinical research into routine patient care could enhance PCP support for clinical trials. Addressing these barriers is critical to improving recruitment efforts and advancing medical research.
Background
Clinical research involving human participants to investigate health and disease is one key to medical advancements. Developing new medicines and methods is time-consuming and costly. The timely recruitment of study participants is one of the most common obstacles to the successful completion of clinical research. Demand for clinical trial participants is the highest it has ever been and will continue increasing as science advances, but an ongoing inability to increase participation is one of the most significant reasons for increased costs and lost efficiency in clinical trials (Rodríguez-Torres, González-Pérez, Díaz-Pérez, 2021).
This shortage of participants requires extending study timelines to meet recruitment requirements. The extended timelines result in increased study expenses and delays in study results. The delays in completing trials translate into impediments in approving new medications and the availability of these medications for clinical use (mdgroup, 2024). Recruiting suitable participants in a timely and efficient manner is a global need. A possible strategy to increase participation is to seek the support of primary/urgent care clinicians who treat patients. There is considerable evidence that clinician recommendations play an important role in helping patients consider participating in clinical trials (Getz, 2023; Woodcock et al., 2021). PCPs are the medical providers that patients know and trust.
PCPs may have a limited understanding of the design of clinical trials, research phases, and patient safety criteria (Baer et al., 2012). PCPs (i.e., family physicians, pediatricians, and internists) provide routine and preventative care. Many are not affiliated with academic medical centers or research institutions and may be unaware of current research efforts, even if research is conducted nearby (Woodcock et al., 2021). This dearth of knowledge contributes to the lack of engagement with researchers and the deficit in finding eligible participants for clinical trials. Clinicians may often be unaware of the clinical trials that may benefit their patients (Wilhøft et al., 2024). Potential participants are either unaware that clinical research is available or that clinical research is a treatment option for them (Yadav et al., 2022).
Those physicians who are aware of the benefits of clinical trials may not have the time or the staffing required to identify appropriate clinical trials for their patients (Woodcock et al., 2021). Primary/urgent care clinicians can be reluctant to present research studies to patients because they lack the information necessary to answer the questions patients may ask about the details of these studies (Detoc et al., 2019). Physicians aware of clinical research opportunities reported referring a median of five patients annually, less than 0.2% of their annual clinical care patient volume (Getz, 2023).
Researchers who hope to engage clinicians for patient referrals need to overcome misconceptions about the dangers of clinical trials and provide information regarding their benefits. Clinical research trials often rely on research–practice partnerships or clinician–researcher collaborations that may be difficult to construct (Douglas et al., 2023). Evidence shows engagement between specialists who conduct research and primary care clinicians increases the likelihood that clinicians will refer patients to specialists involved in clinical research over those who do not participate in clinical research (Baer et al., 2012). A study conducted by the Tufts Center for the Study of Drug Development found that eight out of 10 physicians (80%) and two-thirds of nurses (68%) are most likely to refer their patients to familiar colleagues and research centers (Getz, 2023).
PCPs are the medical professionals best positioned to provide patient education regarding clinical trials, influencing recruitment and patient decision-making (Getz, 2023). The importance of PCPs’ endorsement of research participation cannot be overstated (Baer et al., 2012).
Millar and colleagues (2022) developed a questionnaire to measure facilitators and barriers to PCPs participating in recruitment activities for clinical trials. Their results showed that the two most considerable barriers to trial referral were practitioners being unaware of available trials and the absence of processes for identifying trials for their patient population. These results also showed that the following items, expected to be barriers, were not significant: time to assess study protocols, lack of recognition for referring patients, and lack of financial support for referring patients.
Six independent and three academic or health system-based clinical research organizations operate in the Omaha, Neb., area. These sites recruit for approximately 600 clinical trials per year (Omaha, Neb.: Paid Clinical Trials and Research Studies Near You, updated March 2025). Identifying perceived barriers to supporting clinical trials among local PCPs may allow clinical researchers to facilitate effective relationships with PCPs and increase clinical trial referrals. This study aimed to determine which factors influence the willingness and ability of primary and urgent care providers in the metropolitan area to refer patients to clinical trials. The data were further explored to determine how prior research experience impacts their perceptions.
Methods
Study Overview
The study used an existing questionnaire of barriers and facilitators to PCPs’ involvement in clinical research (Millar, Taft, Weir, 2022). This survey demonstrated good internal consistency for five factors and good predictive validity for the intention to participate in clinical trial recruitment.
Investigators utilized a group sampling survey design to assess the barriers and facilitators that PCPs experience when supporting clinical researchers and clinical research trials.
Questionnaire
The survey was administered as a paper or electronic survey. Minor modifications were made to the existing questions. The first change was that a third option of “both” was added for the question: Have you ever been a co-investigator or a principal investigator for a clinical trial? The second change added a “prefer not to say” option to the question: What is your gender? The question “To what extent would each of the following patient-related factors be a barrier to you?” was removed. The survey included 26 questions about barriers and facilitators that were answered on a 7-point Likert scale, and additional questions about the participants’ demographic characteristics and experiences with clinical trials.
Survey Participation and Procedures
The study was reviewed by The George Washington University Institutional Review Board and was determined to be exempt. This study targeted PCPs in the Omaha, Neb., metro area. Participants were identified through a Google search of local PCPs. E-mails for providers were verified through Anymail.finder.com. Participation was voluntary and no incentives were provided. Completion of the survey implied consent. Between October and December 2024, survey invitations were sent to advanced practitioners, including nurse practitioners, physician assistants, medical doctors, and doctors of osteopathic medicine. Study data were collected and managed using REDCap electronic data capture tools hosted at The George Washington University by Research Technology Services (Harris et al., 2009). Paper forms were hand-delivered to clinics to offer an alternative response method and retrieved within five to seven days. The survey remained open for 12 weeks in electronic format and six weeks in paper format. There was no direct contact between the researcher and participants; all instructions were provided within the form.
Data Analysis
Descriptive analysis was completed for each survey question. One responder with missing data for research experience was excluded from the analysis regarding research experience vs. no research experience. For each Likert-scale item, the median was calculated, representing the central tendency of participant perceptions. Following the full-group analysis, participants were divided into two groups: those who had been principal investigators (PIs) or co-investigators (Co-Is) and those who had never been PIs or Co-Is, to determine if there were any significant differences in their responses to the Likert Scale questions. A Mann-Whitney U Test, a nonparametric test, was conducted to compare the two independent groups with a significance value of p < 0.05.
Results
Respondents
Forty-nine of the 628 (approximately 8%) providers who were sent the survey responded. The respondents consisted of 61% females and 39% males, and 55% were MDs. Approximately 23% had previously served as a PI or Co-I for a clinical trial. Twenty-eight respondents (57%) had never referred patients to a clinical trial. Of the 21 respondents (43%) who had ever referred patients to trials, seven had referred five or fewer patients in the last three years (see Table 1).
Overall Survey Responses
Respondents reported that the most frequently cited barriers to referring patients to clinical trials were: lack of time to assess study protocols, lack of time to discuss research participation with patients, unawareness of existing trial opportunities, and absence of a clinic-wide process to identify suitable trials (see Table 2). Respondents reported most frequently that an introduction to studies presented at their clinic, dedicated clinic referral workflows, and electronic health record (EHR) alerts with documentation of patients’ enrollment and study outcomes would facilitate referrals to clinical trials. Dedicated research time and bilingual study coordinators also ranked high as ways to facilitate referrals.
Respondents did not express concern that referring patients would have an adverse effect on their relationships with patients. Overall, respondents viewed mistrust of clinical trials and researchers neutrally; however, respondents with no research experience showed higher levels of distrust than those with experience. Most respondents reported that recognition or financial support for referrals were not factors in their decisions to refer patients to clinical trials. When queried about the importance of clinical trials and their role in supporting patient recruitment, the majority reported that they do not find it personally rewarding or important. However, when asked if recruiting patients in the primary care setting would significantly increase participation in clinical trials, most respondents agreed that it would.
Research Experience Versus No Experience
A review of the overall data revealed notable differences between respondents with prior experience (n=11) in clinical research and those without such experience (n=37). The results of the Mann-Whitney U test are detailed in Table 2. Respondents with prior research experience were more likely to complete protocol-related tasks like prescreening. In contrast, those without prior experience reported being less likely to spend time on research-directed tasks.
Discussion
This study aimed to determine the factors that influence the willingness and ability of PCPs in Omaha, Neb., to refer patients to clinical trials. The data also explored how prior research experience, specifically PI or Co-I roles, shape provider perceptions. The findings revealed several factors, including behavioral tendencies, time-related constraints, and trust issues, all impacting provider support of clinical trial referrals.
The most commonly reported barriers were a lack of awareness of available trials and inconsistent clinic processes for identifying suitable studies. These findings suggest that logistical and structural issues may play a large part in referral practices. This population did not reflect concerns cited in the literature, such as requiring financial incentives, fears of losing control over patient care, or loss of patients to researchers (Taft et al., 2020). These results align with prior findings from Millar et al. (2022), who also noted similar systemic and procedural obstacles in primary care settings.
Time constraints emerged as a prominent barrier, particularly regarding reviewing study protocols and discussing research participation with patients. This perception was widespread but varied significantly based on research experience. Providers with prior PI/Co-I experience were more likely to cite time constraints as a challenge to participating in active trials. However, they were less likely to identify patient screening and research conversations as burdensome. This distinction suggests that research experience may mitigate perceived time barriers through increased efficiency and familiarity with research processes. Previous literature did not look at the differences between those with previous research experience and those without.
Despite shared concerns about time, workflow interventions such as EHR recruitment alerts were noted as potential facilitators. However, consistent with earlier research (Taft et al., 2020), EHR integration alone has not significantly improved trial referrals and can lead to alert fatigue. Tailoring these systems to practice-specific workflows and utilizing an alert management program may enhance their utility and effectiveness (McGreevey et al., 2020).
Regarding educational needs to address mistrust of clinical trials, unawareness of available trials, and recommendations for site processes to identify patients, the study found that most providers were not interested in in-service training; however, those with PI/Co-I experience reported significantly greater interest. Both experienced and inexperienced providers agreed that in-clinic study presentations about available trials would increase the likelihood of patient referrals, suggesting that concise, practice-based educational interventions may be more effective than traditional training formats.
Trust also emerged as a differentiating factor. While most respondents expressed neutral views about the potential impact of research referrals on patient relationships, those without PI/Co-I experience reported significantly higher levels of mistrust toward sponsors and investigators. This finding supports the notion that prior research involvement positively shapes attitudes toward clinical trial partnerships and reduces barriers to support of clinical trials.
A key finding relevant to the study’s purpose is that, although providers acknowledged the potential of primary care-based recruitment to increase clinical trial participation, they did not perceive referrals as a valuable or personally rewarding component of their professional role. Even providers with prior research experience did not report increased personal fulfillment from referral activities. These results suggest that enhancing provider motivation and shifting perceptions of the value of clinical research are critical to improving referral behavior.
The data indicate that addressing practical and perceptual barriers is necessary to increase PCPs’ support of clinical trials. Targeted education, mentorship programs, and improved transparency around clinical trial processes can help foster trust and support. Importantly, embedding research referrals into clinical workflows and professional development goals may encourage providers to view these activities as integral to comprehensive patient care.
Limitations
A primary limitation of this study is its low response rate (49/628, 8%), which may compromise the generalizability of the findings. Possible areas of selection bias are that participation was entirely voluntary and uncompensated. It is possible that providers with more positive attitudes toward research, or those with prior experience in clinical trials, may have been more likely to respond. This could inflate estimates of support or awareness of clinical trials. Further, providers were identified via Google search and verified with Anymail.finder.com. This sampling method could miss providers not well represented online, such as smaller practices and providers without strong web presence, leading to coverage bias.
Efforts to increase sample size and ensure greater demographic diversity would improve future research’s statistical power and external validity. Although the racial and ethnic distribution of respondents was consistent with 2018 census data for practitioners in the Omaha metropolitan area, the gender distribution for this survey was predominantly female MDs.
Conclusion
In alignment with the study’s purpose, this research identified multiple factors—logistical, perceptual, and experiential—that influence Omaha-based PCPs’ willingness and ability to refer patients to clinical trials. Notably, prior research experience plays a significant role in shaping perceptions related to time, trust, and educational interest. Strategies that integrate clinical trial referrals into routine care, promote interprofessional collaboration, and elevate the perceived value of clinical research among providers are essential for increasing participation and improving the broader clinical trial ecosystem.
Table 1: Respondent Demographics
| Question | n | % |
| Ever Referred patient to clinical trial | ||
| Yes | 21 | 42.9 |
| No | 28 | 57.1 |
| Approx. How many patients have you referred to clinical trials in the last three years? | ||
| None | 28 | 57.1 |
| 5 or fewer | 7 | 14.3 |
| 6-25 | 8 | 16.3 |
| 26 or more | 6 | 12.2 |
| Experience as a clinical trial investigator (PI or Co-I)a | ||
| Both | 4 | 8.2 |
| Neither | 37 | 75.5 |
| PI | 0 | 0.0 |
| Co-I | 7 | 14.3 |
| Age (years) | ||
| Under 40 | 13 | 26.5 |
| 40-49 | 18 | 36.7 |
| 50-59 | 10 | 20.4 |
| 60-older | 8 | 16.3 |
| Gender | ||
| Male | 19 | 38.8 |
| Female | 30 | 61.2 |
| Race or Ethnicity | ||
| Black/African American | 6 | 12.2 |
| Hispanic Latino | 1 | 2.0 |
| White | 42 | 85.7 |
| Provider Role | ||
| MD | 27 | 55.1 |
| DO | 3 | 6.1 |
| PA | 10 | 20.0 |
| FNP | 5 | 10.0 |
| APRN | 4 | 8.0 |
| Board Certifications/Specialtyb | ||
| Family Medicine | 25 | 51.0 |
| Urgent Care | 5 | 10.0 |
| Internal Medicine | 11 | 22.0 |
| Pediatrics | 1 | 2.0 |
| a) 1 participant did not answer
b) 7 participants did not answer |
Table 2: Median Scores for Survey Items on Barriers and Facilitators to Referring Patients to Clinical Trials
Scores are reported for all respondents and participants with and without previous research experience.
| Scale | Median
n=49 |
Median
(with previous research experience) n=11 |
Median
(without previous research experience) n=37 |
|
| Likelihood of participating in clinical trial referral activities | Very unlikely(1)-(7)Very likely | |||
| Refer patients to participate in trial* | 4 | 6 | 4 | |
| Look for active trials for patient | 2 | 4 | 2 | |
| Conduct preliminary screening for eligibility* | 3 | 5 | 2 | |
| Educate patients about trial participation* | 4 | 5 | 3 | |
| Participate in in-service training about conducting trials* | 3 | 5 | 2 | |
| Barriers: Factors preventing referral of patients to clinical trials | Not at all(1)-(7)Very much | |||
| No time to assess protocols* | 5 | 4 | 6 | |
| No time to discuss research with patients* | 5 | 4 | 5 | |
| Do not receive recognition for referring patients | 4 | 4 | 3 | |
| No financial support for participating in referral | 3 | 2 | 3 | |
| Not aware of what trial opportunities exist | 6 | 5 | 6 | |
| No clinic-wide process to identify appropriate trials | 5 | 4 | 6 | |
| Unsure how to evaluate study protocols | 4 | 3 | 4 | |
| Absence of feedback about trial results | 4 | 4 | 4 | |
| Barriers: provider concerns about patient health management | Not at all a concern(1)-(7)Significant concern | |||
| Study could negatively affect relationship with patients | 2 | 2 | 2 | |
| Lose control over managing patient’s care | 2 | 2 | 2 | |
| Uncertainty about health effects of investigational treatments | 4 | 3 | 4 | |
| Uncertainty about trustworthiness of study sponsor or investigator* | 4 | 2 | 4 | |
| Facilitators: factors that would make clinicians more likely to refer patients to clinical trials | Would not increase my likelihood at all(1)-(7)Much more likely | |||
| Introduction to study presented in clinic | 6 | 6 | 6 | |
| Consistent clinic-level workflow for referring patients | 5 | 5 | 5 | |
| Electronic health record recruitment alerts | 5 | 5 | 5 | |
| Documentation of patient enrollment and study outcomes in electronic health record | 5 | 5 | 5 | |
| Bilingual coordinator to help refer non-English speaking patients | 4 | 2 | 4 | |
| Dedicated time to participate in research | 5 | 5 | 5 | |
| Facilitators: importance of trial referral in professional identity | Does not describe me at all (1)-(7)Describes me very much | |||
| Facilitating clinical trial recruitment is a valuable part of my job | 2 | 3 | 2 | |
| Referring patients to clinical trials is personally rewarding | 3 | 4 | 2 | |
| Recommending studies to patients is important to me | 3 | 4 | 3 | |
| Recruiting Patients via primary care clinics will significantly increase clinical trial participation | 5 | 5.5 | 5 |
*denotes a significant difference (p < 0.05) between those with and without previous research experience
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Toni J. Sokol, MS, MHA, DHSc, is a Country Studies Operations Manager with Pfizer and recent graduate of the doctoral program in Health Sciences at The George Washington University School of Medicine and Health Sciences.
David A. Scalzitti, MS, PhD, is an Associate Professor at The George Washington University.
Joyce R. Maring, EdD, is Executive Associate Dean for Health Sciences and Chair of Physical Therapy and Health Care Science at The George Washington University.
