A Practical Approach to Clinical Trial Diversity

A 2021 study in the Journal of the American Medical Association found that minority groups were underrepresented in US-based vaccine clinical trials, with white people accounting for ~80% of participants (1). Although researchers broadly acknowledge that trial representation should mirror the many different populations who could benefit from a drug, lack of diversity continues to hamper clinical-trial effectiveness. To address this problem, the pharmaceutical industry must increase awareness about clinical trials and reduce barriers to participation in them.

Benefits of Diverse Trial Populations
Recruiting diverse trial populations increases healthcare equity. In time, that could alleviate a historic problem: that minorities are “the very same groups disproportionately affected by the diseases being studied in clinical trials” (2). Increased representation also enables clinicians to hone their evaluation of treatment outcomes across many different populations. For example, black trial participants tend to show more adverse reactions to blood thinners and asthma medications than do white participants. Collecting data from a representative pool is critical to evaluating a drug’s efficacy and risks for the many patients who might need it.

Strategies for Increasing Patient Diversity
Despite recent guidance from the US Food and Drug Administration (FDA) (3), little actionable advice exists for increasing trial participation among underrepresented groups. Part of the reason for trial homogeneity relates to participant availability. Historically, white men have had better access to healthcare providers than have other demographic groups, and eligible patients tend to learn about trials from their doctors. Access to education — again favoring white men — also correlates with understanding the importance and procedures of clinical studies.

To reach underserved populations, drug developers and clinicians must invest in communication through targeted media campaigns, community-based enrollment events, and even visits to physicians’ offices in remote locations. Speaking with underserved populations about trial availability, prepaid travel services, and stipends and reimbursements can encourage applicants who otherwise could not participate. Outreach also might include education about programs such as the Ensuring Access Act, which guarantees that the first US$2,000 that a participant collects in trial compensation does not count against public healthcare benefits (4).

Recruitment and Retention
Working with patient-support service providers can enhance trial accessibility further, connecting participants with coordinators who can answer trial-related questions and help with transportation, paperwork, and payments. In addition to managing complex logistics, patient-support partners can help to improve trial outcomes by boosting recruitment and retention. These services can facilitate participation and thus increase the likelihood of securing a diverse range of participants.

Trial retention cannot be overlooked because 85% of all trials encounter delays due to retention issues (5). Support-service coordinators can prevent costly delays by establishing relationships with trial participants as well as their families and caregivers. Patients will know that they have advocates — people to call when flights are canceled or when reimbursement delays cause financial difficulties. A “human touch” makes participants feel less like test subjects and more like people, encouraging them to complete their trials.

Achieving inclusive representation in clinical studies is a difficult but not insurmountable task. Life-science companies can attract large, diverse participant pools by reaching patients where they live, providing targeted and meaningful messaging about the benefits of trials, and offering ongoing assistance. Partnering with a support-services team helps to ensure that patients can continue their participation, often for several years, with limited disruption to their daily lives. Such a practical approach to clinical trial diversity can increase testing of therapies across all relevant populations, enabling better science and faster commercialization.

References
1 Flores LE, et al. JAMA Network Open 4(2) 2021: e2037640; https://doi.org/10.1001/jamanetworkopen.2020.37640.

2 Wilder JM. Scientific and Ethical Considerations for Increasing Minority Participation in Clinical Trials. Clinical Trials in Vulnerable Populations. Prostran M, Ed. IntechOpen: London, UK, 2018; https://doi.org/10.5772/intechopen.70181.

3 CDER/CBER. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry. US Food and Drug Administration: Silver Spring, MD, 2020; https://www.fda.gov/media/127712/download.

4 S.139 — 114th Congress: Ensuring Access to Clinical Trials Act of 2015. GovTrack 1 October 2021; https://www.govtrack.us/congress/bills/114/s139.

5 Hargreaves B. Clinical Trials and Their Patients: The Rising Costs and How to Stem the Loss. Pharmafile 11 March 2016; http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss.

Scott Gray is cofounder and chief executive officer of Clincierge, 190 North Independence Mall West, Philadelphia, PA 19106; 1-888-458-8579; https://clincierge.com.