Clinical Researcher—February 2022 (Volume 36, Issue 1)

PEER REVIEWED OPINION

Awawu Igbinadolor, MD; Suvi Gross; Benjamin Karsai

As clinical research professionals, we are very proud of what our industry has achieved over the last 12 months. Countless lives will be saved by the COVID-19 vaccines and treatments produced by the tireless work of research sites across the country and the gracious contributions of study volunteers. However, the pandemic has also shined a light on the inequities of pharmaceutical clinical research. Many of these landmark trials were delayed due to their initial failure to enroll a sample of subjects reflecting the ethnic makeup of the country.

The failure of research sites to enroll a representative sample of the U.S. population is nothing new. Racial and ethnic minorities continue to be severely underrepresented in clinical trials investigating treatments for cardiovascular, pulmonary, metabolic, and infectious diseases. Considering that these diseases disproportionately impact the African American community, as researchers, we must frame the diversity deficit as nothing less than a scientific crisis. As our industry continues its fight against the pandemic, we must recognize that only through diverse clinical trial participation will the next generation of therapeutics benefit all Americans.

Since 2015, our research team has prescreened thousands of patients for clinical trial participation. Over these years, we were able to build a study patient database in which almost half of those prescreened are of African American descent. We are particularly proud of this achievement considering that African Americans are less than a quarter of our city’s population. In this article, we will share our research site’s best practices for fostering diversity in patient recruitment. These adoptable site level strategies focus on garnering the trust of minority patients through education, access, comfort, and encouraging diversity within clinical research teams. Finally, we offer recommendations to pharmaceutical sponsors on how to promote diversity in trial enrollment more broadly.

I. A Call to Action for Investigators of Color

Twenty years of attitudinal studies examining clinical trial participation continue to confirm a stark reality: “mistrust of clinical investigators is strongly influenced by sustained racial disparities in health, limited access to healthcare, and negative encounters with heath care providers.”{1} Given this inequality, it is little surprise that “African Americans report concern that the findings associated with their participation will not benefit the African American community.”{2}

Understanding these inequities is essential when considering solutions for closing the diversity gap in clinical research. As an industry, we find ourselves in a conundrum of trust. Without trust, we do not have access to communities of color. Without access, we cannot foster trust through education. One of the best ways we can address the conundrum of trust is by encouraging research sites to sprout from within communities of color. Medical doctors within these communities can educate patients about research with a baseline of trust, which in turn fosters confidence in clinical trial participation.

With more investigators of color, the conundrum of trust is replaced by a virtuous circle. As these efforts foster diversity in clinical trial enrollment, the clinical data collected will encourage more inclusive drug development. As newly developed treatments directly benefit these groups, more patients of color will be willing to enroll in clinical trials. This article is a call to action for more medical doctors of color to become clinical investigators.

II. Diverse Study Teams, Diversity in Recruitment

Any solution to bolster diversity in clinical research must acknowledge, empathize, and grapple with the historic abuses endured by the African American community in the name of science. As a clinical investigator of color, the lead author of this article is exceedingly conscious of our industry’s checkered past. From the exploitation perpetuated on unwitting African American test subjects at the Tuskegee Institute in Alabama from the 1930s into the 1970s to the enrollment of African American boys (without consent) into etiology research as recently as the 1990s, examples of malfeasance against blacks in clinical research are shockingly frequent and widespread. When considering this history, it is unsurprising that the primary impediment in African Americans’ willingness to volunteer for a clinical trial is mistrust in academic and research institutions.

Garnering patient trust may be important in building a successful medical practice, but it is fundamental in developing a vibrant research operation. Many investigators fail to make the distinction between patients visiting a practice out of medical necessity and study subjects participating in research as volunteers. A study patient’s decision to participate in a study stems, first and foremost, from the trust he or she has in the investigator and the research team.

In our industry, you often hear that “minority groups will only trust medical professionals who look like them.” This statement is an egregious oversimplification. The conundrum of trust is much more nuanced. Considering the historic deficits and inequities suffered by ethnic minorities, patients of color require reassurances that they will not be treated differently due to their race. They will place their confidence in a medical team which will value their health and well-being irrespective of their identity. If a patient observes a study team comprised of many different backgrounds cooperating and valuing one another, then the patient will anticipate the same treatment in turn. Therefore, diversity in patient enrollment begins with a diverse study team.

Many site managers believe that promoting diversity requires hiring policies that give special treatment to candidates of color. In fact, the opposite is true. Impartiality in hiring practices should naturally result in a study team which reflects the local community. When our site’s management interviews someone for an open position, we place zero emphasis on a candidate’s ethnicity, religion, or sexual orientation. In fact, in our hiring process, traditional considerations such as prior experience or certifications are secondary to a candidate’s attitude, amicability, and character. At our site, applying this approach over time has resulted in a remarkably diverse research team from many different backgrounds including African American, Caucasian, Hispanic, Mixed Race, and East-Asian descent.

Most importantly, as part of our hiring practices, our emphasis on character rather than professional background has garnered a study team with a passion for patient care and wellbeing. Clinical research is an exceptionally difficult profession because it is fundamentally a human enterprise. Our sponsors and monitors are human beings checking the compliance and safety of human volunteers participating in a human run clinical study. At the center of this human maelstrom is the site’s staff. Our research center’s management has committed extensive time and resources toward cultivating a company culture centered around patient care, comfort, and satisfaction. Our staff training emphasizes an etiquette toward study volunteers exemplifying empathy and respect. This attitude is immediately recognized by prospective study participants (of all ethnic backgrounds) and garners the baseline of trust necessary for diverse clinical trial enrollment.

III. Comfort and Trust Go Hand in Hand

As with other businesses, customer support and satisfaction are the benchmark of a research site’s standards and quality service. At first glance, this statement seems obvious, but too often these fundamentals are lost on clinical investigators who fail to distinguish between sick patients in need of treatment and study volunteers offering their time for scientific advancement. In addition to outstanding medical care, the best way an investigator can show respect to his or her trial participants is through a steadfast commitment to a comfortable and positive study experience. A research center’s investment in patient satisfaction garners trust overall and is critical for improving diversity in trial recruitment.

The professionalism and integrity of a research organization is immediately apparent upon entering an office. Our site has invested heavily in patient comfort and satisfaction. The research center is completely separated from the lead author’s physician practice and is custom built specifically for study participants. The waiting room for study volunteers is spacious, cozy, and well lit. Instead of plastic or wooden chairs, patients wait for their study visit on wide recliners with massage capability. Our study volunteers have access to a wide variety of entertainment, including all the major movie streaming services. Whether a patient has arrived for a prescreening, or an end of treatment visit, they are welcome to all the snacks and refreshments they desire.

For longer visits, study participants receive catered lunches or dinners from the local restaurants of their choosing. In short, we strive to make our research center more comfortable than the study volunteers’ own homes. At first glance, such investments might seem like a strain on a research center’s budget, but in our experience, these expenses pale in comparison to the additional enrollment generated by these efforts. Our investments in patient comfort have improved our recruitment/retention efforts overall and resulted in consistent and ethnically diverse study enrollment.

Patient comfort and trust go hand in hand. A site’s willingness to devote its resources toward a patient’s satisfaction signals its dedication to the health and well-being of its study volunteers. Considering the historic discrepancies in minority access to quality healthcare services, a study team’s devotion to its study volunteers’ comfort and satisfaction is paramount in garnering the trust necessary for patients of color to participate in your site’s clinical studies.

IV. Industry Level Recommendations

At the start of a clinical trial, sponsors often ask how they can best support our recruitment efforts, and may offer a selection of conventional flyers/posters or marketing items which fall far short of promoting diverse clinical trial enrollment. With more than a decade of experience working with major pharmaceutical/biotech firms and contract research organizations (CROs), our study team has identified three strategies which would greatly promote inclusive patient recruitment efforts across the country. These approaches involve targeted allocation of research funds and strategies for supporting medical doctors who would like to become investigators.

Supporting Education Within Local Communities

Encouraging diversity in clinical trial enrollment will require concerted outreach and education within communities of color. One of the most potent tools at our industry’s disposal is advertising. Research centers are a part of their community and likely know how to allocate ad dollars to maximize a campaign’s impact within the local culture. Offering sites strong discretionary budgets for local advertising and community events is one of the best ways pharmaceutical sponsors can support education, garner trust, and improve enrollment outcomes.

Rewarding Ethnic Diversity in Patient Enrollment

A track record of diverse patient enrollment assumes inclusive hiring practices, outreach to historically neglected communities, and considerable investment in study participants’ care, comfort, and satisfaction. If the industry values such efforts, then ethnically inclusive patient recruitment should be considered a specialized skill and, as such, be compensated accordingly. Through greater financial incentives, study sponsors encourage research sites throughout the country to make the investments necessary to help close the ethnic diversity gap within pharmaceutical clinical research.

Access, Training, and Support for Investigators of Color

There is a considerable barrier to entry for medical doctors looking to participate in clinical research. Sponsors and CROs will usually only work with investigators who already have a substantial research pedigree. Many doctors gain study experience by acting as sub-investigators on clinical trials. However, considering that there are 8,350 principal investigators in the United States, of which only 9.8% are black, it is safe to assume that the doctors of color have limited options in building their research resumes.{3}

Industry could foster more investigators of color through events which not only aim to educate existing investigators of their study pipeline, but also facilitate networking opportunities for medical doctors looking to get involved in clinical research. These efforts could further be supported by providing grants to research centers willing to offer mentorship and sub-investigator opportunities to medical doctors underrepresented in our industry.

V. Conclusion

As an industry, we have made real strides in recognizing and acknowledging this scientific crisis. To close the diversity gap in clinical trial enrollment, we must place a greater emphasis on the ideals of education, impartiality, and exceptional service. On the site level, more medical doctors of color must take the initiative to become clinical investigators. Site managers should encourage and value diversity within their clinical trial teams and invest more in the comfort and satisfaction of their study participants. Finally, study sponsors should support these efforts through financial incentives and networking opportunities for new investigators of color.

There is no single solution which will address the conundrum of trust between researchers and minority patient populations; however, together we can take the necessary steps to ensure that our clinical trials produce groundbreaking therapies that serve all Americans.

References

Boulware LE, Cooper LA, Ratner LE, LaVeist TA, Powe NR. 2003. Race and trust in the health care system. Public Health Rep 118(4):358–65. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497554/
Corbie-Smith G, Moody-Ayers S, Thrasher AD. 2004. Closing the circle between minority inclusion in research and health disparities. Arch Intern Med 164(13):1362–4. https://pubmed.ncbi.nlm.nih.gov/15249343/
2021. Principal Investigator Statistics and Facts in the U.S. https://www.zippia.com/principal-investigator-jobs/demographics/