The Time is Now to Promote Clinical Trial Workforce Diversity

How can we restore and build trust between minority patients and clinical trial researchers? And how can doing so transform healthcare by helping clinical trials better serve the broader population? These are important questions that deserve our time and attention.

The low levels of participation of minority populations in clinical research are clear. Numerous sources have, for years, cited the underrepresentation of ethnic and racial minorities in clinical trials. While the statistics vary, they are very stark in nature with significant underrepresentation by non-white populations reported across multiple sources.¹ Even more discouraging are the findings from a recent report by the Tufts Center for the Study of Drug Development. They found that nearly 20% of all drug and biologic approvals between 2007 and 2017 were missing data on participant race for all referenced pivotal trials and that 50% of drug approvals did not include participant ethnicity data on any of their trials.²

SubjectWell has been collecting statistics on how race and gender impact clinical trial participation and patient sentiment during the COVID-19 pandemic. The latest findings from a June survey of 553 respondents suggest twice the number of African Americans (26%) versus Caucasians (13%) feel “not at all likely to consider participation in a clinical trial for a condition other than COVID-19”.³ Further, 56% of African Americans responded they would be “very concerned about COVID-19 exposure when taking part in a clinical research study” versus 31% of Caucasians. And this is but one of the groups tracking and reporting trial participation data of minorities in COVD-19 vaccine trials.

COVID-19 has made the importance of promoting diversity in clinical trials even more clear. The pandemic has thus far disproportionally impacted minority populations, and our ongoing failure to adequately represent all patients regardless of demographic background has never been more important to remedy than it is today. Underscoring this is the fact that Moderna Therapeutics, a leading contender in the race for a vaccine trial, recently announced it is slowing enrollment in the COVE Phase III trial.⁴ The enrollment slowdown is meant to ensure Moderna has enough minorities, who are most at risk of the disease.

The consequences are serious—the lack of participation in clinical trials by minority populations weakens the clinical data used by healthcare professionals to determine the best treatment programs and areas worthy of further study. The U.S. Food and Drug Administration (FDA) recognizes this critical shortcoming and encourages minority populations to join clinical trials. According to one FDA source, “Participants in clinical trials should represent the patients that will be using the medical products though this is often not the case. Racial and ethnic minorities are underrepresented in clinical trials.⁵

Numerous attempts have been made by the industry over the last few decades to expand communications with minority populations to increase clinical trial participation. Success has been limited and fitful. Unfortunately, broader health inequities, a deep-seated wariness about clinical trials, and other factors have stymied meaningful progress. It’s long past time to try a new way of tackling the problem.

The Association of Clinical Research Professionals (ACRP) believes that by fostering a more diverse clinical research workforce, we can change this dynamic and promote diversity in clinical trial participation. Studies show most people who join clinical trials either learn about them from a healthcare practitioner or family member. Increasing diversity in the clinical research workforce is the first step in gathering better clinical data for minority health decisions.

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, a research center addressing critical issues in the conduct and oversight of clinical trials, recently issued a report noting,“Efforts to increase the diversity of the research work force should be prioritized. A workforce that is able to relate, empathize, and communicate with patients is better able to build trust and to connect with and provide care for potential study participants.” The report further suggested, “a clinical research workforce that is diverse itself is better able to prioritize, connect, care for, and successfully recruit a diverse participant population in research, and collectively we should strive to diversify the workforce”.⁶

In 2019, ACRP’s Partners in Workforce Advancement (PWA), a collaboration of clinical trial sponsors, research organizations, investigator sites, academic institutions, the National Institutes of Health (NIH) and FDA, launched an innovative pilot project, Find Your Element, a digital media campaign to raise awareness of the clinical research profession among a diverse population of students. The goal: to grow and diversify the clinical research workforce, ultimately impacting the diversity of patients in clinical trials and expanding medical evidence for diverse populations. The clinical research industry offers high-paid jobs that often only require an associate degree. A report published in June 2020 by ACRP and TEConomy Partners, LLC, assessing the clinical research workforce “reveals a profession driven by high-quality jobs with significant demand from a growing clinical research industry and opportunities for entry-level positions to develop careers in the health innovation sector.”⁷

In the Find Your Element campaign, the audience is young minority adults in high school and early college levels (16 to 22-year-olds). The Find Your Element campaign encourages students to visit a webpage where they can learn more about careers in clinical research which can lead them to explore colleges and universities offering degrees and certificates in clinical research as well as explore ACRP’s “Getting Started in Clinical Research” website where they can learn more about different career paths, take introductory training programs, explore internship and job postings and more. In additional to the digital advertising campaign, materials are also available for organizations to download where they can build awareness of clinical research as a career option at live or virtual job fairs.

Results from our pilot outreach to 400,000 students has resulted in over 90,000 visits to our webpage; in essence since January 2020, nearly 100,000 more students are aware of clinical research as a career option that might not ever have heard about this in the past. The pilot project has helped us to determine and refine the most appropriate messaging and media outlets to reach an even larger audience. Our campaign will be modified according to lessons we have learned as we expand to new cities, target additional ethnic and minority groups, and expand our age range to capture the attention and imagination of middle schoolers.

There are other efforts out there to be applauded and encouraged. For example, in Massachusetts, Project Onramp is helping oversee an internship program fueled by four leading life science organizations—MassBio, MassBioEd, Massachusetts Life Science Center, and Life Science Cares. The program connects passionate, high-achieving, four-year college students with paid internships of up to 12 weeks. Across the state, leading companies will collectively be reserving a minimum of 75 internship slots for Project Onramp’s new Life Sciences Scholars Program. Promoting diversity in the clinical trial workforce will have a number of benefits, says Project Onramp participant Laurie Halloran, BSN, MS, CCRA, president and CEO of Halloran Consulting Group, not the least of which will be to “bring a legitimacy to clinical research it doesn’t currently have [when] the patient population we’re studying needs to be [more] diverse,’ told ACRP in August, 2020.⁸ Certainly the work of MRCT, provides a robust roadmap and comprehensive list of resources and practical ideas that employers of all types and sizes across the life sciences industry can implement.

It’s not going to be easy to promote diversity. It’s going to take hard work on a number of levels to reverse current trends and address systemic disparities. And it’s going to take time. Looking ahead, ACRP’s goal in 5 to 15 years is to achieve a thriving clinical trial workforce with enough people in the industry to do the research, but also a workforce that is more diverse and capable of building trust with minority populations and boosting their representation in clinical studies. This will lead to more accessible research, better data available for making clinical decisions, and improved health for minorities. We are committed to being part of the solution—how about you?

Beth Harper is the Workforce Innovation Officer for ACRP.

References

1. Yates, I, et. al. Representation in Clinical Trials: A Review on Reaching Underrepresented Populations in Research. Clinical Researcher. August 10, 2020. Retrieved from: https://acrpnet.org/2020/08/10/representation-in-clinical-trials-a-review-on-reaching-underrepresented-populations-in-research/​
2. Pena, Y., et, al. The Critical Need for Transparency and Disclosure of Participant Diversity in Clinical Trials. Clinical Researcher. August 10, 2020. Retrieved from: https://acrpnet.org/2020/08/10/the-critical-need-for-transparency-and-disclosure-of-participant-diversity-in-clinical-trials/​
3. Spinner, J. SubjectWell eyes diversity in COVID-19 vaccine trials. Outsourcing Pharma.com. August 27, 2020. Retrieved from: https://www.outsourcing-pharma.com/Article/2020/08/27/SubjectWell-eyes-diversity-in-COVID-19-vaccine-trials​
4. Moderna Slows Vaccine Trial Enrollment to Ensure Minority Representation. September 4, 2020. Retrieved from: https://www.thestreet.com/investing/moderna-mrna-stock-coronavirus-vaccine-covid-trial-enrollment​
5. FDA: Racial and Ethic Minorities in Clinical Trials. https://www.fda.gov/consumers/minority-health-and-health-equity/racial-and-ethnic-minorities-clinical-trials​
6. MRCT Guidance Document: Achieving Diversity, Inclusion and Equity in Clinical Research. August 6, 2020. Available for downloading at: https://mrctcenter.org/diversity-in-clinical-trials/​
7. ACRP Special Report: An Assessment of the Adequacy of the Clinical Research Workforce. Available for downloading at: https://acrpnet.org/special-report-an-assessment-of-the-adequacy-of-the-clinical-research-workforce/​
8. ACRP Blog: Diversity Will Broaden Clinical Trial Workforce. August 17, 2020. Retrieved from: http://acrpnet.org/2020/08/17/diversity-will-broaden-clinical-trial-workforce/​