Late last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced new industry-wide Principles on Conduct of Clinical Trials. The principles focus on four main areas: building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities, reducing barriers to clinical trial access, using real-world data to enhance information on diverse populations beyond product approval and enhancing information about diversity and inclusion in clinical trial participation.
PhRMA Announces Principles on Clinical Trial Diversity
The principles also called on pharmaceutical companies to boost education about the role of clinical trials in the medical community, increase clinical trial awareness and diversity by improving health literacy and community outreach, adopt enrollment and retention practices that enhance inclusiveness and make trials less burdensome for participants, and broaden eligibility criteria to increase diversity enrollment.
In the guidance, PhRMA references the history between Black Americans and the medical community, specifically noting that 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, 1932-1972” and that the “serious mistakes and moral breaches” in that study led to major changes in how clinical trials are conducted in order to protect the rights, safety, and well-being of clinical trial participants.
PhRMA also notes that enhancing diversity in clinical trial populations will lead to studies that are more representative of the patient populations that are most likely to use the product under study if it achieves regulatory approval. The guidance offers the example of diseases that disproportionately affect specific racial and ethnic populations, such as sickle cell disease, which predominately affects patient populations of African descent.
As may be expected, PhRMA continues to highlight the importance of real-world data, noting that during the post-approval phase, continuing to collect clinical real-world data/real world evidence may be an important method of supplementing the trial data and serve as a way to enhance understanding of drug effects in diverse patient populations.
PhRMA recommended that biopharmaceutical companies that adopt the principles also establish or maintain policies that address the points outlined in the guidance document, specifically focused on enhancing the diversity of clinical trial populations and promoting enrollment practices that lead to clinical trials that better reflect the populations most likely to use the medical product upon approval. PhRMA also encouraged those companies to put those policies on their website for the public to view.
“The industry’s new clinical trial diversity principles are an important step toward greater health equity,” said Stephen J. Ubl, president and chief executive officer of PhRMA. “We are addressing issues of mistrust and working to reduce systemic issues that deter communities of color from participating in clinical trials, so that those patients who want to participate, can.”
These new guidelines, developed through meetings with African American care providers and nationwide conversations with leaders in minority communities, will take effect April 14, 2021.