Clinical Researcher—August 2022 (Volume 36, Issue 4)

PEER REVIEWED

Emily Botto, BA; Maria Florez, MA; Adrelia Allen, PharmD; Ruma Bhagat, MD, MPH; Ellyn Getz, MPH; Kenneth Getz, MBA

 

Clinical trial participant diversity has been a key topic in the pharmaceutical industry for decades. The subject first entered the literature following the National Institutes of Health’s (NIH’s) Revitalization Act of 1993 and was further propelled into the spotlight by the African American Heart Failure Trial in 2004.{1} Research conducted following these landmark documents has shown that racial and ethnic diversity in clinical trial participant populations can help identify variations in treatment outcome, thereby increasing the accuracy and safety of results across populations. Despite mounting evidence of the importance of participant diversity in the drug development process and an increasing number of initiatives to promote it, low representation of Black, Indigenous, and People of Color (BIPOC) among the global clinical trial participant population persists.{2,3}

As the issues surrounding participant diversity become better understood globally, driven in part by new guidance from the U.S. Food and Drug Administration (FDA){4} and publication requirements from peer-reviewed journals,{5} more eyes are turning to the next frontier in drug development diversity, equity, and inclusion (DEI): the clinical research workforce.{6–8} Studies regarding the effect of diverse healthcare professional (HCP) staff in improving outcomes for BIPOC patient populations indicate that addressing established racial and ethnic disparities in the global clinical research workforce may be an important element in promoting participant diversity.{9,10}

This study is an expansion and update of a study conducted by the Tufts Center for the Study of Drug Development (CSDD) at Tufts University in 2008 among 1,376 U.S.-based principal investigators, which found that significant racial and ethnic disparities exist among clinical investigators despite a comparable interest in clinical research involvement.{11} The authors also proposed that physician race or ethnicity may influence the race or ethnicity of clinical trial volunteers—a conclusion supported by other recently published manuscripts.{8} Although the 2008 study was limited to U.S. respondents, due to the increasingly global nature of the clinical research enterprise, as well as evidence of the need for both environmental and racial and ethnic diversity in the global clinical trial participant population, the research team felt that it was important to consider global perspectives in this follow-up initiative.{12–14}

This updated study includes responses from nurses and other allied health professionals in addition to those of physicians. Individuals from this demographic, like physicians, interact with patients on a regular basis and are crucial to patient care in both clinical care and clinical trial settings. Additionally, non-physician allied health professionals have been shown to experience barriers in terms of racial and ethnic disparities, and their perspective is critical to promoting diversity among entire clinical trial teams.{15}

Understanding how HCPs are motivated to get involved in clinical research, as well as perceived barriers to involvement, is an important step to providing opportunities for HCPs from all backgrounds to contribute their expertise to the clinical research workforce.

Study Methodology

Survey design and analysis planning were conducted and reviewed by a large working group of 24 organizations between December 2020 and March 2021. Following review and approval by the European General Data Protection Regulation (GDPR) committee and ethical review board at Tufts CSDD, the survey was distributed to a global audience between April and July 2021. Survey distribution was conducted through collaborations with a number of professional associations in addition to purchased lists.

Racial and ethnic identities were defined within the survey instrument and are provided in Table 1 as seen by respondents. These categories are consistent with those reported in a recent COVID-19 study{16} and informed by classifications recommended or used by United Nations and the U.S. Census Bureau, among others.{17–21}

Table 1: Race and Ethnicity Definitions as Seen by Respondents

Race and Ethnicity
Asian	Persons having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
Black (or of African Descent)	Persons having origins in any of the black racial groups of Africa.
LatinX (Spanish Origin, Hispanic, or Latino)	Persons of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.
White	Persons having origins in any of the original peoples of Europe.
Other	Includes* “American Indian” (A person having origins in any of the original peoples of North and South America, including Central America), and who maintains tribal affiliation or community attachment); “Pacific Islander” (those having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands); “Other” (some other race, ethnicity, or origin); and any respondent selecting two or more of the available options.

*Racial and ethnic identities collapsed into the “Other” category were defined separately within the survey instrument.

Raw data were stored in Microsoft Excel and data cleaning and analysis were conducted in SAS version 9.4. Analyses performed included descriptive statistics, frequency comparisons, coefficients of variation (defined as the ratio of standard deviation to the mean), comparisons of mean overall and subgroup response values, significance testing, and correlations. Subgroups were created based on white or non-white racial and ethnic identities as well as highest degree earned by respondent, with MD/PhD compared as a subgroup to overall respondents. Analyses were conducted on nursing subgroups as well; however, certain questions were only shown to half of respondents. In these areas, the white/non-white subgroup sample of nursing respondents was insufficient for meaningful analyses.

Results

Respondents to the survey by region reflected the proportion of invitations sent to North American vs. Outside-North American HCPs. In addition to 34,552* purchased list e-mail addresses receiving the invitation, 10 professional associations distributed the survey to their members via e-mail or social media pages. Of these, 611 respondents consented to participate in the online survey, with 54% of respondents from North America (U.S. or Canada) and 46% from outside North America. Respondent characteristics are summarized in Table 2.

Table 2: Respondent Characteristics

	N	Percent of Total Overall	Percent of Total North America	Percent of Total Outside-North America
Highest Degree Earned
Medical or doctoral degree	295	62%	53%	72%
Nursing degree	115	24%	32%	16%
Other	66	14%	15%	12%
Sex
Female	207	56%	61%	50%
Male	162	44%	39%	50%
Race & Ethnicity
White	253	68%	71%	64%
LatinX	16	4%	3%	6%
Asian	56	15%	12%	18%
Black	12	3%	4%	2%
Other (including mixed race)	37	10%	10%	10%

*The number of additional invitations sent by professional associations are not available, therefore, response rate can only be estimated (~2%).

This survey was open to both HCPs with and without clinical research experience, and the data show a fair balance between the two backgrounds, with 56% of respondents reporting having been on study staff (i.e., part of a clinical research team) in the past (see Table 3).

Table 3: Clinical Research Experience by Subgroup

	Total N = 366	Overall Non-White	Overall White	MD/PhD Non-White	MD/PhD White	Nurse Non-White	Nurse White
Without Clinical Research Experience	44.2%	45.4%	45.1%	35%	30.9%	55%	68.5%
With Clinical Research Experience	55.8%	54.6%	54.9%	65%	69.1%	45%	31.5%

Overall, white and non-white respondents reported similar levels of clinical research experience. Given the options of “extremely interested,” “somewhat interested,” and “not at all interested,” non-white respondents—both overall and within the MD/PhD subgroup—selected “extremely interested” in higher proportions. In North America, non-white MD/PhDs were significantly more likely (α = 0.001) to be “extremely interested” in clinical research work (see Table 4).

Table 4: Percent of Respondents Without Clinical Research Experience Reporting “Extreme Interest” in Clinical Research by Subgroup

	Total N = 133	Overall Non-White	Overall White	MD/PhD Non-White	MD/PhD White
All Regions	27.9%	35.7%	24.7%	50.0%	29.7%
North America	25%	40%	20.3%	87.5% α	22.7%
Ex-North America	33.3%	31.8%	34.5%	28.6%	40%

α = p-value < 0.05 in chi-square testing between white and non-white respondents in given subgroup.

Respondents with No Clinical Research Experience

Respondents with no work experience in clinical research were asked to rate a variety of barriers to clinical research involvement as “very important,” “somewhat important,” or “not at all important.” The percentages of total respondents in the given subgroup who chose “very important” for each barrier are reported in Table 5.

Table 5: Percent of Respondents with No Clinical Research Experience Reporting “Very Important” Barriers to Involvement by Subgroup

	Total N = 197	Overall Non-White	Overall White	MD/PhD Non-White	MD/PhD White
Time constraints	48.6%	47.8%	48.9%	54.2%	50%
Lack of access to clinical trials	39.7%	55.6% α	30.9%	54.2%	42.1%
Personnel needs	32.6%	37.8%	29.7%	47.8%	32.4%
Infrastructural needs	29.5%	37.8% α	26.1%	52.2%	29.7%
Lack of patient interest	21.2%	30.2% α	15.2%	23.8% α	8.1%
Complexity of the study	18%	18.2% α	16.1%	22.7%	16.2%
Lack of potential personal benefit	16.9%	31.8% α	10%	31.8% α	2.8%

α = p-value < 0.05 in chi-square testing between white and non-white respondents in given subgroup.

A higher proportion of non-white MD/PhDs indicated that a variety of barriers were “very important” to their decision not to participate than did white MD/PhDs. Chi-square testing showed significant differences in white and non-white MD/PhDs in lack of patient interest (α = 0.04) and lack of potential personal benefit (α = 0.008). Overall, non-white respondents also reported most barriers as “very important” to their decision not to become involved in clinical research in higher proportion than white respondents, except for “time constraints,” which was the highest reported barrier overall. Statistically significant differences were seen between white and non-white respondents in “lack of access to clinical trials” (α = 0.01), “infrastructural needs” (α = 0.009), “lack of patient interest” (α = 0.006), “study complexity” (α = 0.0008), and “lack of potential personal benefit” (α = 0.004).

The North American subgroup saw similar results among overall respondents, with non-white North American respondents also reporting “lack of access to clinical trials” as a “very important” barrier to clinical research work in significantly higher proportion than white respondents from this region (α = 0.013).

These data indicate that higher interest shown by non-white respondents, and particularly non-white doctors (Table 4) is accompanied by higher barriers to entry (Table 5).

When asked which trial sponsor would make the respondent “more likely,” “less likely,” or would not change their attitude (“neutral”) toward becoming a clinical researcher, government and academic institutions were chosen as “more likely” at the highest rate, with industry selected at the lowest rate. The percentage of total respondents in the given subgroup who chose “more likely” for each type of trial sponsor are reported in Table 6.

Table 6: Percent of Respondents with No Clinical Research Experience Reporting Which Institutions Funding Clinical Trials Would Make Them “More Likely” to Become a Clinical Researcher

	Total N = 101	Overall Non-White	Overall White	MD/PhD Non-White	MD/PhD White
Government	72.3%	58.1% α	78.6%	66.7%	81.5%
Academic	67.3%	58.1%	71.6%	80%	84%
Non-profit	51%	53.3%	50%	57.1%	46.2%
Industry	22.4%	30%	19.1%	28.6%	26.9%

α = p-value < 0.05 in chi-square testing between white and non-white respondents in given subgroup.

Respondents with Clinical Research Experience

The research team also surveyed those HCPs familiar with clinical research to deduce how they became involved and analyzed the differences in experience between subgroups. As seen in Table 7, the most reported catalysts to involvement in clinical research included applying for a job or grant and being asked by a mentor or peer to join the study. “Other” was selected by 17% of respondents with clinical research experience, which warrants further investigation into other catalysts to clinical research involvement.

Table 7: Types of First Involvement (Overall) for Respondents with Clinical Research Experience Responding to Survey Question

	Total N = 197	Overall Non-White	Overall White	MD/PhD Non-White	MD/PhD White
Mentor (included in Mentor or Peer)	23.4%	16.7%	26.8%	18.8%	29.6%
Mentor or Peer	38.6%	30%	41.7%	33.3%	44.9%
Applied for Job/Grant	24.4%	28.3%	23.6%	27.1%	20.4%
Proactive	8.1%	13.3%	6.3%	10.4%	7.1%
Recruited/Referred*	11.7%	11.7%	11%	10.4%	14.3%
Other	17.3%	16.7%	17.3%	18.8%	13.3%

*Includes recruitment by industry sponsor, academic institution, contract research organization, or site management organization, as well as referral via institutional office or site network.

This survey found that, out of those respondents with direct clinical trial experience, both overall white respondents and white MD/PhDs were more likely to have had a mentor or peer help them get involved in clinical research. Of those respondents with mentors, 93% agreed that mentors made them more comfortable with the clinical trial process, 91% agreed that mentors made them more comfortable with referring and screening patients for clinical trials, and 87% agreed that mentors helped them find greater access to clinical trials. Additionally, 100% of non-white mentored respondents agreed that mentors made them more likely to continue to get involved in clinical trials after their first trial, compared to 88% of white respondents.

In North America, non-white respondents were similarly less likely to have had a mentor get them involved in clinical research (see Table 8). North American results also revealed that non-white respondents were more likely to have acted proactively to get involved in clinical trials (contacting a pharma/biotech company, requesting a peer to include respondent in the study). Although this was true for the overall dataset as well, the gap was larger among North American respondents. “Proactive” means of involvement in clinical research require expressed interest in the field and more effort from the individual, further highlighting the gap in access and opportunities readily available to this subgroup (Table 5).

Table 8: Types of First Involvement (North America) for Respondents with Clinical Research Experience

	North America Total N = 102	North America Non-White	North America White
Mentor (included in mentor or peer)	16.8%	8.6%	20.9%
Mentor or Peer	34.3%	25.7%	38.8%
Applied for job or grant	22.5%	22.9%	22.4%
Proactive	10.8%	20%	6%
Recruited/Referred	10.8%	11.4%	10.4%
Other	21.6%	20%	22.4%

These findings imply that white candidates have more access to mentorship opportunities both globally and within the North American region.

Conclusions

Tufts CSDD’s 2008 publication exposed the disparities that exist in the race and ethnicity of principal investigators in the U.S. by identifying a trend of non-white investigators conducting and initiating fewer trials annually despite similar levels of interest.{11} This study, 14 years later, shows that although the incidence of non-white MD/PhD respondents in clinical research is still lower than white MD/PhDs, “extreme interest” in participation as a clinical researcher is higher among non-white MD/PhD respondents, particularly in North America (Table 4).

By analyzing the root of these disparities at a global level and across allied health professions, the research team not only identified similar disparities in incidence of BIPOC healthcare professional involvement to the 2008 study, but also found that BIPOC healthcare professionals perceive higher barriers to clinical research involvement in access, infrastructural needs, lack of patient interest, complexity of the study, and lack of potential personal benefit. This report of higher barriers—particularly in access—among both global and North American non-white respondents was consistent with a lower proportion of this subgroup reporting having a mentor or peer ask them to join their first trial compared to white respondents.

This element is important to address, as mentorship has been found to be a more effective tool in diverse recruitment than other DEI initiatives such as mandatory diversity training, job tests, and grievance systems.{22} This is supported by perspectives from respondents to this survey, who reported overwhelmingly that having a mentor had a positive impact on their clinical research experience, as well as increased their likelihood to refer patients and to continue working in clinical research after their first trial.

Emphasizing these barriers to access for BIPOC-allied health professionals and taking steps to mitigate their effect, such as instituting mentorship and educational programs among allied health students from diverse backgrounds, could contribute to decreasing disparities in the clinical research workforce. Although these programs do exist within the U.S., wider adoption of them—both outside the U.S. and across a larger proportion of U.S. sites— is an essential element in promoting diversity in the clinical research workforce, as is the availability of early intervention programs to promote clinical research education.

Existing programs are led by various organization types, including universities,{23} government agencies,{24} and professional associations.{7,25} Some industry sponsors have mentorship programs focused on postdoctoral candidates,{26} however these are not specifically dedicated to diversity and are limited in their target audience. Implementing more diversity-targeted programs within sponsor companies, as well as encouraging their development among sites and potentially sponsoring associated costs, are promising ways that industry can directly contribute to enabling more HCPs from a broader range of backgrounds to enter the clinical research workforce.

Study Limitations

The methodology in this study had several limitations. The original distribution plan was to reach out to professional organizations for collaboration, which was the strategy for Tufts CSDD’s comparable 2008 study. However, heavy burdens due to surges in COVID-19 infections and deaths during the distribution of this survey may have affected both the willingness of professional associations to distribute the survey as well as the willingness—or bandwidth—of HCPs to contribute time to fill out the survey. Additionally, the increased number of surveys from other sources targeting HCPs during this time exacerbated survey fatigue.{27} Survey completion rates could have also been affected by these elements, as well as the length of the survey instrument. Bias may have been introduced with these recruitment methods, as the predominant demographics of members of professional associations collaborating in study distribution may have been more heavily represented than those of associations that did not respond to requests to collaborate.

Other limitations included the low awareness of DEI research from organizations outside the U.S. Some organizations, in addition to low awareness of the topic, did not perceive DEI as applicable to their region, further complicating this method of recruitment. Lack of familiarity and consideration for ethnic and racial diversity initiatives in clinical research outside the U.S. is a separate topic that requires further research and advocacy, as drug development is a global process that impacts patients worldwide. Due to these limitations, purchased e-mail lists were used.

Finally, a low number of non-white respondents made it difficult to avoid a white/non-white dichotomy. In a global study featuring a variety of geographic areas, each with varying racial and ethnic majorities, this subgroup approach may not fully account for the variations in experience among non-white respondents. Tufts CSDD is interested in following up on this study to expand the dataset and allow deeper subgroup analyses, particularly during a time when the COVID-19 pandemic does not restrict availability and enhance survey fatigue among HCPs.

Despite these limitations, these results can provide important insight into the barriers and experiences of the global clinical research workforce and introduce the subject of workforce diversity on a global scale.

Acknowledgements

The authors wish to thank representatives from the following organizations for providing research grants and assistance to support this working group study: AbbVie; Amgen; the 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; Genentech, a member of the Roche group; Sanofi; Seagen; the Society for Clinical Research Sites; Syneos Health; Takeda; and UCB. The research team also thanks professional associations contributing to survey distribution, including: 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, Israeli Medical Association, and the Boston Children’s Hospital Program for Research Assistant Development and Achievement.

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Emily Botto, BA, (emily.botto@tufts.edu) is a Research Analyst at the Tufts Center for the Study of Drug Development in Boston, Mass.

Maria Florez, MA, is a Research Consultant at the Tufts Center for the Study of Drug Development.

Adrelia Allen, PharmD, is the Senior Director of Clinical Trial Patient Diversity at Merck.

Ruma Bhagat, MD, MPH, is Principal Science Leader for Health Equity and Population Science, Product Development, at Genentech, a member of the Roche group.

Ellyn Getz, MPH, is the Director of R&D Patient Partnerships at CSL Behring.

Kenneth Getz, MBA, is the Executive Director and Research Professor at the Tufts Center for the Study of Drug Development.