“We recognize that achieving clinical trials that include diverse populations presents an ongoing challenge,” the PhRMA trade association says in a recent addition to its white paper on Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. In October, PhRMA’s board approved a new section called Commitment to Enhancing Diversity in Clinical Trial Participation, effective April 14, 2021. The other Principles have been in effect since June 1, 2015.
In the new section, PhRMA notes, “Enhancing meaningful representation of diverse participants in clinical trials would help provide information about drug response and measures of safety and efficacy in populations that have been historically under-represented and under-studied, in particular Black and Brown people.”
As part of the new commitment, PhRMA pledges to:
- Build Trust and Acknowledge Past Wrongs. Diverse populations, in particular those from Black and Brown communities, have historically been underrepresented in clinical trial populations. Some patients may not trust medical research due to historical mistreatment of participants, such as those involved in the U.S. Public Health Service Syphilis Study at Tuskegee from the 1930s into the 1970s. That study’s serious mistakes and moral breaches led to major changes in how clinical trials are conducted in order to protect the rights, safety, and well-being of clinical trial participants.
- Increase Clinical Trial Awareness and Diversity by Improving Individual Health Literacy and Community Outreach. Educational efforts are a key component of reaching underrepresented populations. PhRMA says its educational efforts are aimed at increasing access and reducing barriers for underrepresented and diverse populations to participate in clinical trials. When conducting clinical trials, PhRMA members should commit to using approaches to address all health literacy backgrounds and different levels of clinical trial awareness. Improving health literacy and clinical trial awareness should also extend to the individual needs of a diverse population with a given disease, potential comorbid conditions, and continued experience with a disease or condition(s).
- Broaden Eligibility Criteria to Increase Diversity in Enrollment When Scientifically and Clinically Appropriate. Broadening eligibility criteria for a clinical trial, when scientifically and clinically appropriate, maximizes the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice, without jeopardizing patient safety. PhRMA members should commit to adopt practices for determining eligibility criteria that will help the clinical trial population to reflect the diversity of the patients who will be using the drug if approved.
Edited by Michael Causey