Why Diversity in Clinical Trials Matters
Clinical research participants should reflect the disease population in question. This statement is a no-brainer; however, drug and device developers and clinical trials teams have failed countless times at accomplishing this task.
A commonly cited example of such shortcomings can be seen in the case of a heart failure drug called BiDil. Tested in the early 2000s, BiDil initially failed large clinical trials.¹ Later, however, when the drug was studied in a more diverse group of patients, it was discovered to reduce heart failure deaths in African American patients by 43%. In 2005, the U.S. Food and Drug Administration (FDA) approved it specifically for African American patients.²
BiDil was the first drug to ever carry a race-based indication. While this decision was seen by some as a step forward in addressing health disparities, it also sparked controversy. Many experts argued that if earlier clinical trials had enrolled a diverse population, the drug could have been recognized for its race-specific impact earlier and saved more lives.
Despite the rising awareness in the early 2000s of the consequences that come from a lack of diversity in clinical trials, the problem remains today. Many recent pivotal oncology trials underrepresent minority populations, even though cancer incidence and mortality are often higher in these groups. A 2020 analysis³ stated less than 3% of participants in clinical trials for immune checkpoint inhibitors were Black. Without robust data, it is unclear if these therapies work equally across a broad group of racial and ethnic populations, leading to gaps in care.
These cases illustrate an urgent problem. When diversity is missing from clinical trials, the resulting data are incomplete, which leads to either delayed access or ineffective/unsafe treatment options for certain populations.
Why Diversity Still Lags
The FDA addresses the lack of diversity in clinical trials primarily through the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act,⁴ which requires clinical trial sponsors to submit Diversity Action Plans. The FDA additionally helps by providing guidance on best practices for these plans.
While the DEPICT Act is a step in the right direction, many argue the implementation draws concerns about enforceability. Although the DEPICT Act gives the FDA authority to require post-market studies when diversity goals are not met, it is unclear how and how often sufficient justification will be judged. In addition, the DEPICT Act creates a risk that sponsors will treat diversity as a box to check, rather than genuinely engaging with underrepresented communities. The lack of diversity is solved at the site level; however, site leaders are often unaware of strategies they can use to ensure their enrollment is diverse.
How Sites Can Use Practical Strategies to Increase Diversity
Sweeping reform is not always the answer to improving diversity in clinical trials. Below are six strategies site leaders can implement today to enhance their diversity:
- Build Trust Through Community Physicians—Trust is essential for building a diverse trial. Patients need to receive clear messaging and engage with familiar physicians as well as culturally competent staff. Patients often prefer participating in a trial if their own doctor is involved. Site personnel can engage with community doctors to be brought in as sub-investigators to help patients feel more comfortable about participating in a trial.
- Meet Diverse Patients Where They Are—Sites can partner with community organizations such as churches, advocacy groups, and local clinics. These organizations have already established trust within the underserved populations. By working with these organizations, site leaders can introduce clinical trials in a culturally sensitive environment with trusted community leaders. After the partnership is established, showing up consistently is also essential, since one-off efforts at outreach do not build trust. Maintaining presence in the community beyond enrollment periods is extremely important.
- Train Staff in Cultural Competence—Diversity efforts are not complete after the patient has been recruited. Sites need to feature an environment in which they feel respected. Site leaders can accomplish this by training their staff on cultural humility, implicit bias, and communication strategies.
- Provide Feedback and Transparency to Patients—Many clinical trial participants report feeling disconnected from their trial. Sites can build trust and positive engagement by committing to share study results with their participants (when allowed by the sponsor).
- Give Praise and be Grateful—The decision to participate in a clinical trial is compassionate as well as selfless. It is important for sites to continuously show they are grateful. Many sites send “thank you” cards or e-mails to participants. Such simple gestures can go a long way in encouraging trial retention and future trial participation.
- Reduce Logistical Barriers—Whenever the protocol design allows, sites should ease the burden of trial participation. Adjustments such as offering evening and weekend hours, combining visits (when permitted), and sharing directions/parking instructions can significantly enhance accessibility for working, underserved individuals.
Why You Should Care
The need for diversity in clinical trials is not just about fairness, but better science as well. When data assumptions do not reflect the real world, questions may rightly be raised about the reliability of the results of a clinical trial and the safety of the research itself, leading to damage of public trust.
Governing bodies set the expectations, but the site level is where these expectations succeed or fail. By building trust, expressing gratitude, and easing barriers, sites will achieve diverse enrollment.
References
- Taylor AL, Ziesche S, Yancy C, et al. 2004. Combination of isosorbide dinitrate and hydralazine in Blacks with heart failure. N Engl J Med 351(20):2049–57. doi:10.1056/NEJMoa042934
- Brody H, Hunt LM. 2006. BiDil: assessing a race-based pharmaceutical. Ann Fam Med 4(3):254–60. doi:10.1370/afm.539
- Unger JM, Hershman DL, Fleury ME, Vaidya R. 2020. Representation of racial and ethnic minority populations in U.S. cancer clinical trials: review and meta-analysis. JAMA Oncol 6(10):e191870. doi:10.1001/jamaoncol.2019.1870
- WCG. FDA’s Path Toward Diversity in Clinical Trials: The DEPICT Act and Sponsor Responsibility. https://www.wcgclinical.com/insights/fdas-path-toward-diversity-in-clinical-trials-the-depict-act-and-sponsor-responsibility/
Submitted by Kyle Skelton, Owner at Archway Clinical, LLC, an integrated research organization.
