Representation of Diverse Populations
Focus Area: Current Project
Focus Area: Ethics, Conduct, and Oversight
In the U.S. and abroad, regulatory approvals for investigational products are based on carefully designed, blinded, randomized clinical trials. Ideally, the participant population enrolled in clinical trials reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. As safety and efficacy of drugs and biologics can vary depending on intrinsic and extrinsic factors, including an individual’s sex, race, ethnicity, and age, clinical trials should also provide information that informs the use of therapeutic agents within identified subgroups. However, despite regulatory directives and public expectations, the composition of study samples in most clinical trials does not reflect such characteristics in a manner that would permit analysis of treatment outcome by subgroup. This failure to achieve meaningful diversity limits information about drug response and measures of safety and efficacy in historically under-represented and under-studied populations, in particular woman, ethnic and racial minorities, children, and the elderly.
The MRCT Center is actively working with a dynamic and diverse group of stakeholders, including academic- and industry-based leaders, not-for-profit institutional representatives, patients/patient advocates, and government representatives to define guiding ethical principles, establish standards of approach and practice, and explore solutions to common scientific and sociocultural barriers to meaningful diversity in clinical trials. The project is entitled: Toward a Conceptual and Practical Understanding of Diversity in Clinical Trials: Scientific, Ethical and Socio-Political Considerations.
Current Status: Active Project
Impact: A clear set of ethical principles and a conceptual framework that promote understanding of the goals of diversity, address current barriers to progress, and explore solutions to common scientific and sociocultural barriers to meaningful diversity in clinical trials.
- Develop a statement of principles, a conceptual framework to advance an understanding of the goals of diversity in clinical trials, and resolve existing ambiguities
- Develop synthetic ethical and empirical arguments that justify the goals of diversity in clinical trials and proposed solutions, including scientific, ethical, and sociopolitical positions.
- Examine variability in methods used to define, collect, analyze, utilize, and communicate clinical trial data on race, gender, ethnicity, and age
- Analyze available data to understand the characteristics of clinical trials that successfully recruit versus those that fail to recruit a diverse population of participants
- Identify and define barriers to effective enrollment faced by under-represented participants, referring providers, investigators and their research team, clinical sites, and sponsors and inventory current methods of effective recruitment
- Develop and disseminate actionable and scalable solutions (“tools”) to promote the goal of diversity in enrollment and to facilitate subgroup analysis in clinical trials
- December 2017: Initial teleconference of leadership team
- February 2018: Inaugural conference call held with the working group
- March 2018: Second teleconference held with the working group to refine project scope and deliverables
- April 2018: Third conference call held to discuss the separation of the working group into two work streams (Work Stream I to work on health equity issues and Work Stream II to focus on scientific issues as they relate to variability in drug response, data collection and analysis).
- June 2018: Two separate conference calls held for Work Stream I and Work Stream II to discuss deliverables and delineate responsibilities
- December 2018: Panel discussion at MRCT Center Annual Meeting
- July 2019: Submitted comments to FDA in response to draft guidance on enhancing the diversity of clinical trial populations
- November 2019: In-person meeting of Diversity Workgroup at Harvard Faculty Club
- December 2019: Panel Discussion at MRCT Center Annual Meeting; published Version 1.0 of Diverse Representation and Inclusion in Clinical Research – Principles
Project Leadership: Richardae Araojo (US FDA), Barbara Bierer (MRCT Center), Luther Clark (Merck), David Strauss (Austen Riggs Center), Milena Lolic (US FDA)
Project Managers: Hayat Ahmed, Carmen Aldinger, Laura Meloney,