As the race for a coronavirus vaccine has painfully brought to light, minority groups remain grossly underrepresented in clinical trials. A recent study of all published COVID-19 treatment-related clinical research studies with participants in the United States revealed that one-third of the studies did not report race or ethnicity data. One study did not even collect race data among participants. The study revealed that Black patients were underrepresented in all studies relative to the burden of disease among the Black communities in which these studies took place.
Lack of diversity spans all disease states and demographics. Why is it important that these groups be represented in clinical trials? As we’ve seen with COVID-19, individuals from minority groups often have higher incidences of certain diseases. Plus, patients can respond differently to medical treatments, oftentimes with adverse or fatal reactions, due their ethnicity.
The Center for Information and Study on Clinical Research Participation (CISCRP) conducted a global online study on public/patient perceptions and experiences with clinical research. Responses from over 12,450 individuals were collected: 6 percent self-identified as Black, 10 percent as Asian and 13 percent as Hispanic. The study revealed that 98 percent considered clinical research studies “somewhat/very important” to the discovery and development of new medicines. However, study findings also showed that:
- 33 percent of Black individuals reported having little or no trust in pharmaceutical companies
- 28 percent of Asian individuals have never participated in a clinical trial because of concerns associated with risk
- 53 percent of Asian and 52 percent of Hispanic respondents were the least likely out of any group to recall recently learning about a research opportunity.
This lack of minority representation points to a vicious cycle in clinical trials. Pharmaceutical companies need to recruit more minority participants, but a lack of trust among minority communities results in a reluctance to enroll, leading to low representation.
One effort to address the issue is the FDA’s guidance document on enhancing diversity of clinical trial populations, released last month. The document focuses on eligibility criteria, enrollment practices and trial designs. In October, the Pharmaceutical Research and Manufacturers of America (PhRMA) boardapproved the addition of a principle of conduct on Commitment to Enhancing Diversity in Clinical Trial Participation, effective April 14, 2021. The National Institutes of Health (NIH) has launched the All of Us research program to collect and study data from 1 million or more people over 10 years, with a commitment to recruit a diverse participant pool.
So what can clinical trial sponsors do to help increase diversity in clinical trials? Here are a few strategies and tactics for starters:
DO make diversity an organizational priority.
In today’s sociopolitical climate, organizations across all industries are placing a focus on diversity. On a corporate level, this means instituting policies that value and prioritize diversity. For a clinical trial sponsor, standard operating procedures (SOPs) should reflect those policies and trickle down to who is recruited to participate in clinical trials. This involves more than just inserting policies and procedures on diversity into existing documents. It means tying in diversity to the organization’s mission, vision and values. Visit just about any pharmaceutical company site, and you’ll see a commitment to improving the lives of patients. In order to live up to that promise, an organization’s conduct must reflect that commitment to all patients.
DO instill trust.
As the CISCRP statistics above show, lack of trust is a major barrier to minority participation in clinical trials. The best way sponsors can build trust is through education. This can be through a company website, as well as sharing information at health fairs, health clinics or with private physicians. Trial transparency is key to building trust. Limited internet access notwithstanding, 43 percent of patients search online for clinical study information.1 A sponsor’s clinical trial website can educate visitors by explaining the clinical trial process and what participants can expect. An example of patient-friendly educational material is this animated video by the Pharmaceutical Research and Manufacturers of America (PhRMA) giving a brief overview of the clinical trial process.
DO network.
In tight-knit ethnic communities, word of mouth is one of the most effective ways to promote your clinical trial. Reach out to local churches and community organizations to broaden your reach. The leaders of such groups are viewed with trust, and the messages they share — including yours — are more likely to be accepted.
DON’T use “medicalese.”
The rule of thumb for anyone who’s not a healthcare professional is to write at a sixth-grade reading level. To be truly inclusive, translate your informational materials into the languages most prevalent in the areas where you are recruiting. Your website should also be accessible to those with impaired vision, but keep in mind that internet access and technical skills may be limited in certain geographical areas and populations. And don’t forget to provide sign language interpreters where appropriate. CISCRP offers many resources that help explain clinical trials in easy-to-understand terms.
DON’T be afraid to think outside the box.
Low patient enrollment rates across the board indicate that current recruiting methods are falling short. To optimize recruitment efforts, study sponsors must embrace technology and consider non-traditional approaches. An effective, successful recruitment model is one that brings together all stakeholders: sponsors, recruitment partners, healthcare organizations, trial sites and patient/advocacy groups. If your organization does not have access to underrepresented groups, it makes sense to align with others that do, such as smaller recruiters who may specialize in — and have established trust with — your nice audience. Case in point: TrialScope Connect™[DG1] helped a sponsor meet diversity and inclusion goals for a COVID-19 trial, delivering 600 randomizations in just 32 days.
DON’T reinvent the wheel.
Many resources exist to help sponsors improve the diversity of their study participants. The Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has released “Achieving Diversity, Inclusion, and Equity in Clinical Research,” a comprehensive guidance document with practical, applicable ways to improve diverse representation of participants in clinical research. The MRCT Center also offers a downloadable toolkit with both tools and case studies. “Diverse representation in clinical trials is a principle of a just society, and we need new approaches to mitigate underrepresentation,” said Barbara E. Bierer, MD, MRCT Center Faculty Director. “The inclusion of underserved and hard-to-reach populations will take focus and engagement, new technologies and approaches, accountability, and long-term commitment to ensure real change.”
Most importantly, don’t give up. Participant diversity is more than just an often-repeated platitude; it is a critical component of research, ensuring that medical advancements will be for the betterment of all.
Check out our interview with Dr. Jean Bonnet, founder of the Ethnicity and Disease Community Empowerment Center. And learn more about the networking and technological advantages of the industry-first TrialScope Connect patient referral collective.
1TransCelerate BioPharma Inc., 2019
[DG1]Link is at bottom of blog post
