Individuals who participate in clinical trials should reflect those who have the disease or condition or, if the epidemiology is not known, the general population. The demographics of patients with cancer do not match the demographics of patients enrolled in cancer treatment trials.
White patients with cancer are overrepresented in clinical research, while other races and ethnicities, particularly Black, Hispanic, and American Indian/Alaska Natives are underrepresented; other often underrepresented groups include women, children and young adults, people with disabilities, and non-English speakers. These groups do not benefit from, nor have equivalent access to, potentially therapeutic clinical research.
Underrepresentation in clinical research not only contributes to health inequities but also limits the generalizability of the research findings. The goals for improvement of this scenario are two-fold: equitable access to promising new therapeutics and other benefits of clinical research; and clinical trials that appropriately study the safety and efficacy of drugs, biologics, immunotherapies, behavioral interventions, and devices as they affect diverse populations.
The barriers to equitable representation in clinical trials are historical, societal, financial, and practical, and much work needs to be done. In addition to poor access to trials and limited flexibilities in conduct (e.g., visit schedules, transportation to treatment centers, inadequate language translation), the lack of community engagement and mistrust of medical health care systems contribute to underrepresentation. A comprehensive program is needed to promote equitable representation of diverse participants in clinical research. That program starts with leadership and commitment; extends to community engagement, access, education, and communication; encompasses study design, eligibility, conduct, operations, outcomes, and analysis; engages workforce development and training; and concludes with accountability and metrics.
As part of a comprehensive effort to address this complex issue, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard and the Center for Cancer Equity and Engagement at the Dana-Farber/Harvard Cancer Center will offer a six-part virtual course titled “Equity by Design in Clinical Research: Cancer Trials.” The curriculum is designed to build on existing knowledge of ethical and regulatory foundations and will highlight key action areas to support inclusion in cancer clinical research.
While it is expected that course participants will have experience with clinical trials and some familiarity with key principles of diversity, equity, and inclusion, some may not be as familiar with the practical implementation of best practices for diversity in clinical research recruitment, enrollment, and retention in cancer clinical trials. Therefore, practical guidance and actionable steps to advance commitment, communication, partnership, and conduct of trials will be emphasized.
This six-session course, tailored to clinical trialists and multidisciplinary teams engaged in cancer clinical trials, is being offered at no cost and for CME credit to a national audience. Weekly sessions (March 8, 17, 22, 31 and April 5, 14) will include 45 minutes of presentation and 45 minutes of discussion with expert practitioners. Registration is required.
