Emily Botto

Healthcare Provider (HCP) and Patient Advisory Boards (PAB) or Community Advisory Boards (CAB) have become common practice

 among clinical trial sponsors to evaluate the validity and feasibility of study protocols. The expertise of HCPs is essential to the outcomes of these advisory boards (AdBoards); however, recruitment of HCPs for research studies can be challenging, and not much has been written about how to tackle these challenges. The nature of the patient-facing healthcare profession often means that carving out time for AdBoard participation may be more of a barrier for HCPs than the average patient targeted for such discussions.

The COVID-19 pandemic has further impeded attempts at gathering data from HCPs, including physicians, nurses, and physician assistants. The well-documented burnout effect of the pandemic and the increase in requests for surveys or focus groups investigating COVID-19 experiences,

 further contribute to survey and videoconference fatigue. Such difficulties in the recruitment of HCPs can hinder successful implementation of AdBoards. Hence, recommendations and strategies to attract more eligible HCPs to participate in these AdBoards are essential to the support of drug development research.

The increasing prominence of the internet, and by extension the ability to host AdBoards, focus groups, and interviews virtually, has reduced geographic and time-related barriers that previously prevented recruitment of a wider, more diverse sample of participants.

 Although research around the transition from in-person to virtual AdBoards began well over a decade ago,

 the uptake in the medical field has been relatively slow and publications around recruitment strategies and methodology for virtual studies have remained noticeably thin.

 The COVID-19 pandemic, however, forced a rapid shift towards virtual interactions, catalyzing a few studies around the pandemic’s effect on qualitative research methods and best practices. According to a 2021 study by MphaR, 20% of advisory boards had already moved online prior to the COVID-19 pandemic, but 2020 saw this number jump to 80%.

 Despite some research emerging on the topic, indicating increasing interest, the literature on best methodologies for conducting virtual qualitative research in medical science remains scant. The shift in how we recruit and incentivize HCP research participants, in particular, requires additional research for adaptive strategies.

Thus, the purpose of this article is to share learnings related to our effort to recruit HCPs to a virtual AdBoard during the pandemic. We outline the challenges to recruitment, the adaptive strategies used in response to these challenges, and suggest recommendations for future studies.

The aim of this study was to gather a group (n = 4 – 6) of US-based patient-facing healthcare providers with experience treating patients with multiple myeloma to provide input on a Phase III clinical trial protocol for an experimental drug. The inclusion criteria were: (1) US-based patient-facing HCP (2) Currently treating patients with multiple myeloma. Recruitment began following exemption by an independent ethical review board.

Recruitment efforts were done virtually and lasted approximately 2 months. A personalized email containing a screener link to determine eligibility was created. This email contained logistical details related to the duration of the AdBoard (two 2-hour videoconference sessions), participants’ responsibilities (i.e., reviewing the study protocol and providing feedback), and compensation (market rate). In the same email, participants were asked to share the study with qualified colleagues who may be interested in participating. Participants’ input was reviewed by the research team to determine their eligibility. Eligible participants were then contacted regarding their availability.

To ensure that we reached a diverse population of HCPs, we used several outreach outlets. During the first outreach effort (Wave 1), we used an existing purchased list of 733 US-based HCPs comprised of physicians, nurses, and physician assistants in oncology. Recipients who had not clicked on the link or who had not finished the screener were sent a reminder email one week after the initial email, and a second follow-up two weeks after the first. Individuals who chose to click the “unsubscribe” link, or reached out directly to request removal, were immediately removed from the contact list.

The above recruitment strategy was supplemented with a more targeted strategy (Wave 2a), which involved searching for email addresses for potential participants from publicly available sources, including Pubmed, 

, and multiple myeloma research and healthcare institution websites. We considered Wave 2a a pilot run with the intention to expand the strategy depending on the response rate. Our initial search using this method yielded 106 contacts. No other elements of the recruitment strategy were altered for Wave 2a. The following search criteria was used on both PubMed and 

: “multiple myeloma” [or] “hematology.” Filters were applied on Pubmed to exclude any article published before 2017. We also noted the participant’s gender and racial background where possible. This targeted approach resulted in a larger, more diverse pool of eligible participants and an increased enrollment rate, which we will detail in the results section.

Following the initial trial run (Wave 2a), we expanded our effort using this method, which yielded 677 contacts who were sent an email via Qualtrics. In this wave, we made two adjustments: 1) the introduction text was revised to include session dates and was considerably shortened and 2) as opposed to a personalized link, which was used in Wave 1 and Wave 2a, an anonymized link was sent, making it easier for recipients to share the screener with their network. One reminder email was distributed one week after the initial invitation to those who had not unsubscribed from the list.

Lastly, a small number (n = 20) of professional contacts within the research team’s immediate network were also contacted for recruitment.

Participants who qualified for the study were sent an official invitation, consent form, and a Zoom link. A reminder was sent 24 hours prior to the first session to ensure attendance. Overall, two 2-hour AdBoard sessions were held among 5 US-based multiple myeloma healthcare providers. Sessions were recorded and transcribed.

A pre-purchased list of 733 physicians, nurses, and physician assistants in oncology were contacted in late October 2021 during the first phase of recruitment. Of these 733 recipients, 20 unsubscribed (2.7% unsubscribe rate) and 51 emails bounced (7.0% bounce rate). An additional 4 recipients reached out to the research team directly to clarify that they did not treat multiple myeloma and were therefore not interested in the study.

Twelve invitees opened the screener link (“clicks”), all of whom completed the screener. Two additional screener responses were recorded from referrals. One screener respondent specified that they were unable to participate due to scheduling restraints. Of 14 potential participants, 3 were deemed eligible and 2 were enrolled in the study.

Wave 2a was sent to 106 contacts collected from publicly available sources, resulting in 2 clicks and 1 screener completion. The individual who completed the screener was deemed eligible and was enrolled in the study.

Wave 2b resulted in 677 contacts gathered from Pubmed and 

 who were contacted between early to mid-November 2021. Of the 677 contacts, 9 invitees opened the screener link and 7 finished filling out the screener. Six additional recipients reached out via email to inform the research team that they were not available during the session dates, or that they would not be able to devote 4 hours to the project regardless of the scheduled times. These participants did not click on the screener link but expressed interest in participating. One additional screener response was recorded from referrals. A second referral never filled out the screener but was deemed eligible based on known background and experience, however, this individual was not able to participate due to scheduling conflicts. Of the 9 potential participants, 6 were deemed eligible and 2 were enrolled in the study.

Four recipients unsubscribed in this wave, and 1 reached out to the research team requesting removal from the list. See Table 2 and Figure 1 below for recruitment summary for both waves.

Overall, 5 individuals were identified for AdBoard participation and completed all 4 hours of the AdBoard. The original recruitment goal was 6 to 8 participants total, making the final group fall short of meeting this quota. However, this number of participants was sufficient for this AdBoard. Enrolled participant characteristics are provided in Table 1 below.

The screener distribution through the purchased list received a slightly higher volume of responses and a slightly higher response rate overall compared to gathering contacts from publicly available sources. However, the higher response rate did not yield a higher participation rate such that only 21.4% of those contacted via the purchased list were eligible compared to 70.0% of those identified on Pubmed and 

. This problem could be avoided by purchasing a more specialized list; however, such lists can be harder to generate depending on how narrow eligibility requirements may be. For non-physician HCPs, the availability of specialized lists narrows, as many nurse and physician assistant contact lists are not specific to treatment specialty.

In terms of cost, many list providers require a minimum expenditure, the lower end of which typically falls between $1,000 and $2,000 for an annual license, with the cost per contact varying depending on number of uses, type, and size of overall purchase. Specialized contact lists are difficult to use for future projects for general research teams, and the requirement of a larger number of contacts without the ability to repurpose them for other projects further decreases the benefit of purchasing a contact list. While some companies offer a single-use option, which can decrease the overall cost, this gives the researchers less control over the database, and may restrict the ability to send reminder or follow-up emails. Another limitation of purchased lists is that their viability cannot be guaranteed despite their high cost. For example, in this study, the purchased list carried a 7.0% bounce rate.

The distribution using contacts manually collected from Pubmed and 

 proved to be more fruitful. This method allowed the research team to generate a contact list of highly specialized HCPs using targeted keywords (i.e., “multiple myeloma”), which increased the eligibility rate of respondents despite a comparable click rate and referral rate to the purchased list distribution. Further, we were able to track the participant’s demographics (i.e., gender, race, and provider type – physician, nurse, etc.), allowing us to create a more diverse pool of potential participants. The slightly lower click rate and screener completion rate for the Pubmed/

 distribution may be a result of decreased availability from recipients since individuals from Wave 2b were contacted closer to the session dates and were therefore more likely to have scheduling conflicts. This supposition is supported by two factors:

Wave 2a (publicly available sources), which was distributed during the same time period as Wave 1 (purchased list), carried a slightly higher click rate (1.9%) than the purchased list (1.6%)

An increased number of individuals during Wave 2 directly contacted the research team regarding scheduling conflicts

Although Wave 2 also resulted in a high bounce rate (17.0%), the fact that the research team was still able to enroll more eligible participants with this method suggests that a high bounce rate may not heavily affect the success of this recruitment method. However, to avoid collecting out-of-date contact information, we recommend applying a 5-year “Publication Date” filter to the Pubmed search criteria to account for turnover within the institution. 

 also has a filter that only includes studies that are currently recruiting in the search results, which would produce more up-to-date contacts as well. The likelihood of turnover within target institutions is especially high within the last few years due the COVID-19 pandemic, making the application of these filters important for the viability of contacts.

During recruitment, manually gathering contacts from Pubmed and 

 was more time-consuming than using a purchased list, as it required combing through webpages and hand-recording each entry. The research team conducted further research following the conclusion of this study and found that there are software packages (i.e., R and Python) that allow for easier gathering of emails. One such package is R’s 

whichallows researchers to retrieve Pubmed records, including names, affiliations, and emails where available. However, this is only possible for US contacts, as data protection regulations in some ex-US countries (primarily those within the European Economic Area) prevent the availability of this data scraping method internationally. By using appropriate keywords, this program can conduct similar recruitment methods as searching through the platform manually by automatically gathering names and contact information.

Another method includes adding keywords to the Pubmed advanced search function and downloading the full Pubmed text file. From there, it is possible to extract emails from the text file. This method, however, does not include first or last names,

 making it difficult to personalize emails, which some studies deem more effective in reaching potential participants,

 though others have found that personalization has little to no effect on recruitment and enrollment.

 This method is simpler and may be preferable for research teams without experience in R programming.

Utilizing publicly available resources such as Pubmed and 

 can be helpful in AdBoard, focus group, or other qualitative studies where eligibility requirements are strict; the research team can manually comb through records or scrape the webpage for contact information; and/or the study budget does not allow for purchased lists or other common recruitment methods such as social media advertisements.

We note that automatic extraction of email addresses from publicly available sources can be controversial and that some may perceive unsolicited emails from any source as spam.

 However, we believe that using such methods for academic purposes that are directly related to the HCPs’ field of interest is less likely to result in complaints from email recipients compared to the use of a general market list. Further, the low unsubscribe rate from our own study is a potential indication that our recruitment efforts were not perceived as spam by most of the screener recipients. Notably, this effort can be a viable way for academics and scholars operating under a limited budget to achieve enrollment goals given that purchased lists tend to be expensive and, at times, controversial as well.

Nevertheless, it is important to contact only those whose expertise is directly related to the given study and therefore may be most likely to benefit from participation. The study team was mindful to use a targeted approach by only recording emails and contacting individuals from Pubmed and 

 who would be most relevant for our study.

Recent survey research by MphaR suggests that utilizing asynchronous discussion forums—defined within this research as the ability for participants to engage with the content (i.e., relevant publications and materials) on their own time and individually consider their comments and feedback in place of or in addition to video interaction—may be a more productive AdBoard medium. In this survey, 50% of HCPs preferred asynchronous discussion only, while 30% preferred asynchronous discussion in addition to video interaction. Ten percent reported a preference to return to face-to-face, and 10% preferred video only for AdBoard formats.

 Although our AdBoard was conducted synchronously, asynchronous discussion may be an advantage for recruitment to overcome one of the most difficult aspects of HCP recruitment: scheduling. Multiple recipients of invitation emails in this study showed interest in participating but stated that they could not allocate 4 hours to the project due to limited bandwidth or schedule conflicts.

An asynchronous discussion eliminates many of these issues, as participation can take place at any time. With a hybrid method that combines synchronous and asynchronous discussion, the synchronous session could be pared down to a much more manageable length (i.e., 1 hour instead of 4) that may be more accommodating to the average HCP. Several studies have been successful in implementing an asynchronous focus group method for HCP qualitative data collection, further supporting the use and validity of this method among this population.

Though using social media for study recruitment has been studied extensively, few studies concern the recruitment of HCPs.

 Additionally, quantifying the effectiveness of social media on recruitment has proved difficult because previous studies have defined and used different metrics to measure success (i.e., views, clicks, or participant enrollment).

 Pizzuti et al. (2020) found that Facebook was the most commonly used social media platform among US-based HCPs compared to seven other platforms (Snapchat, Google+, Pinterest, Twitter, Reddit, LinkedIn, Instagram).

 Yet, Facebook Ads did not always yield high success rates compared to other social media platforms.

 In fact, our review of the literature revealed that the platform’s success often depended on the target population. Thus, when the recruitment strategy involves social media advertisements, the research team should have a thorough understanding of their target audience, particularly which platform(s) their audience most commonly uses (i.e., Facebook vs. TikTok).

As with the type of platform and general effectiveness of social media recruitment, its cost effectiveness varies widely across studies and target populations. According to Whitaker et al. (2017), in a review of 35 global studies between 2012 and 2017, the average cost of Facebook recruitment for health research was $14.41/participant at $0.51 per click.

 In a separate, randomized controlled trial, the reported cost/randomized participant reached $172.76/participant before the researchers discontinued the social media advertisement due to low engagement.

 Studies that were successful in recruiting their target sample reported a low cost overall and improved cost effectiveness

 compared to other strategies such as email and print ads, while those unsuccessful in social media recruitment often canceled their paid social media advertisement once the effort proved unfruitful24 or hit a cost limit,

 making it difficult to estimate an exact cost if social media were to be used until the full sample size was achieved.

Few online sources reported recruitment methodology for focus group studies, with those reporting cost data instead consisting primarily of cross-sectional or randomized controlled clinical trials. Although some studies identified during this literature review reported on recruitment costs of HCPs via social media,

 and none addressed both. That said, given the review of studies reporting the cost of social media as a recruitment method, accuracy rather than cost seems a more significant limitation.

To get around this limitation, researchers could post on professional groups or associations relevant to their target participants. However, as with any cold call method, the response rates may be low. Professional associations receive a large number of requests and are limited in how many research studies they can promote. During the initial phase of our study, for example, five hematology and oncology associations were contacted regarding the possibility of advertising our study, yet none responded. Often, having professional ties to someone in those organizations can be an effective way to recruit niche populations for qualitative studies. For example, Dalessandro et al. (2018) cited difficulties recruiting LGBTQ participants for a qualitative study but managed to ask a contact to share the study on a private Facebook group, which helped the research team to reach their recruitment numbers.

 Another study cited “partner organizations’ social media outlets” as a recruitment tool.

This professional network requirement to research recruitment is a noted barrier, with McRobert et al. (2018) stating that social media recruitment “relies on pre-existence of a diverse and functioning social network.”

Our institution conducts a wide array of research in a variety of fields and topics, making it difficult to have such contacts available, particularly for studies on niche topics. However, as we demonstrated in this study, recruiting HCPs on a specialized topic without the research team having pre-existing professional ties to HCPs in particular healthcare specialties is still possible. It simply requires additional time, effort, and a bit of creativity. Additionally, though initial recruitment using cold emailing methods can be time-consuming, once the relationships between the research organization and the HCPs have been established, they can lead to improved future recruitment opportunities.

Lastly, using a combination of recruiting methods (i.e., cold emailing; word-of-mouth; social media) provides more viable ways to recruit a diverse pool of participants compared to using one method. For example, social media recruitment is associated with a less diverse sample, namely young, female, white, educated, and economically advantaged, compared to traditional recruitment methods.

 Thus, a combination of the different strategies may be ideal to produce a diverse sample that reaches the target sample for the study.

In this study, collecting multiple myeloma HCP emails from publicly available sources helped the research team to find more eligible participants compared to using purchased lists. Additionally, packages such as R’s 

as well as Khalifa’s strategy to scrape emails from Pubmed make it possible to generate contact lists more suited to the needs of researchers at little to no cost to the institution. Scheduling was a major challenge faced by researchers during this study, which could potentially be mitigated by utilizing asynchronous virtual AdBoards to improve the scheduling process and make AdBoard or focus group participation easier for HCPs from all backgrounds. Although social media recruitment has been studied as an alternative recruitment medium, not much is known about recruiting HCPs with this method, and most studies conclude that its usefulness and cost-effectiveness depends on the target population and the professional contacts of the research team and institution. For small, non-profit institutions, particularly those that focus on a range of research topics and target populations, cold emailing using contacts gathered form publicly available sources is one of the most cost-effective and accurate options for the recruitment of HCPs.

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Articles

Tufts CSDD study addresses barriers in recruitment. 

Methods to Recruit Healthcare Providers for Virtual Advisory Boards in Drug Development

Although we have witnessed increased inclusion of diverse populations in COVID-19 vaccine

 trials over the past two years, in nearly all other disease indications, representation of BIPOC

 populations—black, indigenous, and peoples of color—in clinical trials remains comparatively low, particularly in world regions where most clinical trials are currently conducted

 and where demographics are becoming increasingly more diverse (i.e., North America and Western Europe).

A variety of factors help explain the lack of racial and ethnic representation among clinical trial volunteer participants. Low clinical research literacy, poorly targeted communications, and limited access to clinical research facilities are among top factors mentioned.

 Many note that racial and ethnic representation among the research workforce is essential in reducing barriers to clinical study volunteer participation among historically underrepresented populations.

 A 2008 study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that a physician’s race and ethnicity can influence the race and ethnicity of clinical trial volunteers. The study also found that incidence of participation in clinical research among BIPOC physicians was well below that observed among white physicians. Although interest in becoming a clinical investigator was high among all physicians surveyed, BIPOC investigators tended to conduct and initiate fewer trials annually. In that study, BIPOC investigators also reported fewer infrastructural resources and support compared to white investigators.

More than a decade has passed since the 2008 study. During that time, public and clinical research stakeholder awareness and interest in improving the proportional representation of volunteer participants by race and ethnicity in clinical trials has intensified. Several recent initiatives underscore these changes. The FDA Reauthorization Act of 2017, for example, expanded the FDA’s authority to address barriers to participation in clinical trials (SEC.610.Expanded Access).

 In 2020, FDA issued guidance for the broadening of volunteer eligibility criteria and the enhancement of diversity in clinical trial participation.

 In April 2022, FDA issued draft guidance recommending the development and submission of plans—with each new IND application—for achieving diversity targets, as well as retaining study participants.

 Separately, The Lancet issued a diversity pledge to reinforce its commitment to diversity

 and the New England Journal of Medicine conveyed the importance of diversity in clinical research in a recent editorial.

In late 2020, Tufts CSDD conducted a new study to revisit, characterize, and more deeply examine the relationship between investigative site personnel diversity and study participant diversity.

This research began with the formation of a large Working Group

 of biopharmaceutical companies, contract research organizations (CROs), and one global professional association. The Working Group supported the development of two extensive online global surveys that were distributed between April and July of 2021. These were reviewed and approved by the Tufts University IRB and the university’s General Data Protection Regulation (GDPR) expert reviewer.

The first survey targeted medical professionals, regardless of their involvement in the clinical research process. Its purpose was to gather data about medical professionals regarding their awareness of, access to, training, and involvement in clinical research. The second survey targeted clinical research professionals working at various types of clinical research sites. Its purpose was to gather data on staff diversity at investigative sites, the infrastructure and support available to clinical research staff, and staff perceptions about Diversity, Equity, and Inclusion (DEI).

Definitions of race and ethnicity were presented to respondents participating in both surveys as shown in Table 1. These definitions are consistent with those reported in a 2021 study looking at race and ethnicity of COVID-19 patients participating in 68 studies worldwide.

 Race and Ethnicity—Definitions Presented to Respondents

Survey one: Awareness of, access to, training in, and involvement in clinical research among medical and allied health professionals

In total, 611 respondents participated in the online survey aimed at medical professionals regardless of their involvement in clinical research. Of these, 54% were in North America (US & Canada) and 46% were in Rest of World (ROW). Regarding their education levels, 62% had a doctoral or medical degree, 24% had a nursing degree, and 14% had achieved other educational levels, such as a bachelors or high school diploma. Respondents to the survey were 56% female and 44% male. Racial and ethnic identities were reported as follows: 68% White, 15% Asian, 10% Other (including mixed race/ethnicity), 4% LatinX, and 3% Black.

The survey results show that most medical and allied health professionals who are involved in clinical research believe that mentors made them more comfortable with (1) the clinical trial process (93%), and (2) referring and screening patients for clinical trials (91%). Most medical and allied health professionals involved in clinical research (87%) also believe that mentors helped them find greater access to clinical trials.

The survey findings also indicate that a high proportion of medical and allied health professionals first became exposed to clinical research at the invitation of a peer or mentor. Differences in exposure through a mentor or peer were also observed between BIPOC and white professionals, with 42% of white professionals reporting becoming involved in clinical research in this manner compared to only 30% of BIPOC professionals. Other differences in exposure among BIPOC and white professionals were found when respondents were asked if they first became exposed to clinical research by proactively contacting a pharmaceutical company about opportunities to participate as staff supporting or leading clinical trials. Thirteen percent of BIPOC professionals reported becoming involved in clinical trials by being proactive compared to 6% of white professionals.

Further, differences in access to clinical research opportunities and infrastructure were identified between BIPOC and white medical and allied health professionals who have not been involved in clinical trials. Table 2 shows the barriers to involvement in clinical trials as reported by Physicians, PhDs and nurses who have not been involved in clinical research worldwide.

 Barriers to Involvement in Clinical Research as Reported by Professionals Without Clinical Trial Experience (Global)

Survey two: Investigative site diversity, infrastructure, and support available to clinical research site staff

The primary aim of the second survey was to understand current racial and ethnic representation among research professionals at clinical research sites supporting clinical trials funded by pharmaceutical and biotechnology companies, and the elements that influence staff diversity at these sites. These elements include (1) the types of communities served (i.e., urban, suburban, and rural), (2) the income levels of the patient population served, (3) staff’s access to technologies, (4) training and support available to site staff, and (5) the site’s infrastructure. To that end, in addition to the definitions shown in Table 1, respondents to this survey were also provided with the definitions included in Table 3 below.

 Site Characteristics—Subgroup Definitions

In total, 3,462 respondents—representing an estimated 3,340

 unique sites—participated in this global

 online survey. Of these respondents, 40% were principal investigators, 36% were site directors and managers and other administrative staff, and 25% were clinical research coordinators (CRCs) or clinical research nurses. Respondents to this survey were 61% female and 39% male. Racial and ethnic identities were reported as follows: 69% White, 12% LatinX, 8% Asian, 6% Mixed, 4% Black, and 2% Other.

In addition, survey respondents were asked to estimate the racial and ethnic breakdown/composition of the staff working at their respective sites. Table 4 shows this breakdown by world region and type of research institution. Overall, BIPOC populations were not widely represented among staff at clinical research sites globally. When comparing BIPOC percentage representation by type of institution in North America, higher representation was observed in private sites and site networks compared to academic medical centers and large healthcare systems. When comparing BIPOC percentage representation by type of institution in Europe, significant differences in representation were not observed among private sites, site networks, academic medical centers, and large healthcare systems. BIPOC representation was higher among staff at research sites located in ROW.

 Distribution of Investigative Site Staff by Race and Ethnicity

Clinical research sites were also classified into one of two groupings: ‘High’ Staff Diversity Sites and ‘Low’ Staff Diversity Sites. Sites in the US were classified as High Staff Diversity if their staff was at least 60% BIPOC. Sites in the US were classified as Low Staff Diversity if their staff was 40% or less BIPOC. Sites in locations outside of the US were classified as High Staff Diversity Sites if representation by any one race or ethnicity was 40% or lower; they were classified as Low Staff Diversity Sites if representation by one race or ethnicity was 60% or higher. Sites that fell outside of these parameters (i.e., the 50th percentile) were excluded from supplementary analyses. It is important to note that less than 1% of European sites met the criteria for the High Staff Diversity grouping—this includes sites in Eastern Europe as well as the UK, Germany, Spain, France, and other parts of Western Europe.

Clinical trial volunteer diversity is strongly associated with diversity in the clinical research workforce

Racial and ethnic representation among the clinical research site workforce is associated with racial and ethnic representation in clinical trial volunteer enrollment. To explore the strength of this relationship, respondents were asked to estimate the racial and ethnic breakdown of patients enrolled in their recently conducted clinical trials. These estimates were then cross tabulated against the groupings for High Staff Diversity Sites and Low Staff Diversity Sites, and chi-square tests were conducted to determine statistical significance. As shown in Table 5, the enrollment of BIPOC patients was significantly higher at High Staff Diversity Sites, including all site types. This result was statistically significant.

 Relationship Between Staff Diversity in Diversity in Patient Enrollment in Trials (Global)

The relationship between diversity in patient enrollment and investigative site staff diversity has important implications for the development of DEI plans and policies. If the aim is to increase representation among clinical trial volunteers, policies and plans must also prioritize improvements in representation of BIPOC populations among investigative site staff; thus, understanding the basic characteristics of sites that show High Staff Diversity is a meaningful starting point for future initiatives in this space.

Characteristics of investigative sites reporting higher staff diversity

This study sheds light on the characteristics of sites reporting higher levels of staff diversity—though it also uncovers barriers faced by those sites reporting lower levels of staff diversity. Sites reporting higher racial and ethnic diversity among their staff tended to be in urban areas, service low-income communities, and have centralized clinical trials offices to support research teams—in greater proportion than sites reporting lower staff diversity levels. As shown in Table 6, two of these findings were statistically significant.

 General Characteristics of Investigative Site Staff by Diversity Subgroup

Clinical research sites reporting High Staff Diversity levels also reported greater use of technologies and infrastructure to support the execution of clinical research compared to Low Staff Diversity sites, as shown in Table 7. The difference in use of Patient Management Systems at High Staff diversity sites compared to Low Staff Diversity sites was statistically significant. Additionally, provision of adequate access to Patient Management Data was higher at High Staff Diversity sites. The analysis also revealed that, prior to the pandemic, remote communication platforms were used in higher proportion at High Staff Diversity sites compared to Low Staff Diversity sites, and that the overall current use of these platforms was higher at High Staff Diversity sites.

 Use of Technology and Infrastructure by Diversity of Investigative Site Staff

Not least, this research revealed that High Staff Diversity Sites tended to offer better access to diversity and inclusion, unconscious bias, and inclusive behavior SOPs to its staff. The offering of inclusive behavior SOPs was notably higher at High Staff Diversity sites.

 Presence of Diversity SOPs by Diversity of Investigative Site Staff

The Tufts CSDD Investigative Site Personnel Diversity Study results demonstrate association between reported levels of racial and ethnic diversity among personnel at investigative sites and racial and ethnic representation among volunteer participants enrolled in clinical trials. This finding suggests that increased diversity within the clinical research workforce facilitates the racial and ethnic representation of study volunteers in clinical trials at individual research sites.

This study also offers new understanding about shared characteristics among sites reporting comparatively higher staff diversity and offers insight into the paths followed by medical and allied health professionals toward becoming involved in clinical trials. These elements are key considerations and may be important strategies supporting improvements in racial and ethnic representation among clinical trial volunteers.

Specifically, our results suggest that expanding exposure to clinical research opportunities to all medical and allied health professionals can lead to greater overall staff participation in clinical investigation. Our results show that 87% of all professionals involved in clinical research believe that mentors helped them find greater access to clinical trials, and over 90% of all medical and allied health professionals involved in clinical research report that a mentor made them feel more comfortable with the clinical trial process, as well as in referring and screening patients for trials. However, only 30% of BIPOC medical and allied health professionals first became involved in clinical research by invitation by a mentor or peer compared to 42% among their white counterparts. This last result highlights a disparity in access to mentors in clinical research and the benefits that accompany such connections. Mentorship and other research socialization programs are therefore expected to be effective in increasing overall and BIPOC staff participation in clinical research.

The study findings indicate that the presence of DEI-specific materials and SOPs may play a role in supporting workforce diversity and, in turn, foster diversity and inclusion among study volunteers. First, a strong relationship was identified between High Staff Diversity sites and the availability and use of Diversity and Inclusion, Unconscious Bias, and Inclusive Behaviors SOPs. Second, High Staff Diversity Sites reported access to these SOPs in higher proportion compared to Low Staff Diversity sites. Third, approximately half of staff at clinical research sites—across site types and locations—believe that SOPs for Diversity & Inclusion, Unconscious Bias, and Inclusive Behaviors help increase participant diversity at sites. Our results set the stage for drug development stakeholders to collaborate in the development and dissemination of materials, policies and procedures that elevate awareness and understanding of the importance of inclusive behaviors and minimizing biases. This collaboration is not just isolated to the level of the investigator site, but also can benefit from involvement of sponsoring organizations and CROs to support such efforts to increase DEI awareness.

Altogether, our research demonstrates that a diverse clinical research workforce is associated with diversity among clinical trial volunteers, shows that diversity in the clinical research workforce still falls short of reflecting the diversity of the global patient population, and identifies key areas that can support increased racial and ethnic representation among site staff: offering mentorship in clinical research to medical and allied health professionals, as well as SOPs and educational materials related to diversity and inclusion, unconscious bias, and inclusive behaviors.

, MA, Research Consultant and Senior Analyst, Tufts CSDD, Tufts University School of Medicine, 

, BA, Research Analyst, Tufts CSDD, Tufts University School of Medicine, 

, PhD, Strategic Feasibility Manager, UCB, 

, Senior Director, Global Feasibility, Labcorp Drug Development Inc., 

, PhD, Senior Director Patient Insights and Solutions, Portfolio Transformation and Insights, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 

, Director Oncology Hematology, Janssen Research & Development, LLC,

, MBA, Executive Director and Professor, Tufts CSDD, Tufts University School of Medicine

 for his contributions. The authors also thank representatives from the following organizations for providing research grants and support to this study: AbbVie, Amgen, Association of Clinical Research Professionals, AstraZeneca, Biogen, Bristol Myers Squibb, Covance (now Labcorp Drug Development), CSL Behring, Eli Lilly and Company, EMD Serono, ICON, IQVIA, Janssen, Merck, Otsuka Pharmaceuticals, Parexel, Pfizer, Sanofi, Seagen, Syneos Health, Takeda, UCB, and Genentech, a member of the Roche group. Additionally, the authors wish to thank the following for their assistance: Philippine Nurses Association of America, Asian American Pacific Islander Nurses Association, Taiwan Clinical Research Association, Academy of Physicians in Clinical Research, European Society for Clinical Investigation, ARMA UK, ARCS Australia, Hong Kong Medical Association, the Israeli Medical Association, and the Society of Clinical Research Sites.

Artiga S, et. al. Racial Diversity within COVID-19 Vaccine Clinical Trials: Key Questions and Answers. Kaiser Family Foundation. 2021.

Stewart J, Krows ML, Schaafsma TT, et al. Comparison of Racial, Ethnic, and Geographic Location Diversity of Participants Enrolled in Clinic-Based vs 2 Remote COVID-19 Clinical Trials. JAMA Netw Open. 2022;5(2):e2148325. doi:10.1001/jamanetworkopen.2021.48325

An article published by the New York Times states that the earliest use of the term BIPOC was in 2013. The acronym stands for black, indigenous, and peoples of color.

https://www.nytimes.com/article/what-is-bipoc.html

Getz K, Smith Z, Pena Y.Quantifying Patient Subgroup Disparities in New Drugs and Biologics Approved Between 2007 - 2017. TIRS (2020); 54(6): 1541-1550.

2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.

Emily Botto

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