Yesterday, PhRMA published first ever industry-wide principles on clinical trial diversity, a new chapter in the already existing “Principles on Conduct of Clinical Trials & Communication of Clinical Trial Results.” These new principles have been approved by the PhRMA Board of Directors and will take effect in April 2021.
Critical to enhancing clinical trial diversity is addressing the systemic issues that deter mainly Black and Brown communities from participating in clinical trials, so that those who want to participate, can. We are working toward making our industry consistent in building and bridging a deficit in trustworthiness to better meet the needs of the communities we serve. Our new clinical trial diversity principle addresses:
- Building Trust and Acknowledging Past Wrongs. Some patients may not trust medical research due to the historic record of mistreatment, including from the U.S. Public Health Service Tuskegee Syphilis Study and the exploitation of Henrietta Lacks, whose cancer cells were harvested without her knowledge and have been used over the decades since. Today, patients and research participants’ rights are protected by law and ethics committees, including institutional review boards that oversee clinical trials. Our companies are also committed to enhancing diversity among clinical investigators, working with communities to educate about the role of clinical trials and improving our community outreach so that those who want to participate can do so.
- Reducing Barriers to Clinical Trial Access. To enhance clinical trial diversity, it is imperative for researchers to plan studies and development programs that promote inclusion of diverse populations, implement protocols that define the intended treatment and enrollment populations and seek input from those communities throughout the process. For example, sponsors should consider recruitment challenges and enrollment barriers that may occur as a result of factors such as planned visit schedules, location and financial implications, as well as how these factors might be addressed. It’s also important that researchers adopt practices for determining science-based eligibility criteria that do not inhibit the diversity of the clinical trial population.
- Using Real-World Data to Enhance Information on Diverse Populations Beyond Product Approval. During the post-approval phase, collecting clinical real-world data or evidence can be an important method of supplementing trial data, in compliance with all applicable local laws and regulations. These data can also serve as an effective and efficient means to enhancing understanding of drug effects in diverse patient populations.
- Enhancing Information About Diversity and Inclusion in Clinical Trial Participation. Lastly, biopharmaceutical companies that adopt these new principles commit to sharing information about their policies or practices to increase clinical trial diversity online to promote transparency and accountability.
At the core of these principles is the need for the industry to better serve historically underserved populations. By committing to enhancing diversity in clinical trial populations, we can better reflect the patients that will use the new therapy or medicine being studied and solve for improved health outcomes. For example, different populations may be at higher risk for certain diseases, such as sickle cell disease, diabetes or heart disease. Clinical trials for the development of new medicines for those diseases should aim to reflect the patient population they are aiming to help. Ultimately, diverse clinical trials support a better understanding of the medicine. This is one way the industry can improve the care for the patients we serve.
It is with these core principles in mind that the biopharmaceutical industry commits to continuing to work with patients, patient advocacy groups, regulatory authorities, health care practitioners, academics and policymakers to define the systematic and impactful approaches that can enhance the diversity of clinical trial participants and help reduce health care disparities.
Learn more about these efforts at phrma.org/equity.
Richard Moscicki, M.D. Dr. Moscicki serves as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA. He joined the organization in 2017 after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.