Nicholas Warren, PhD

ONCOLOGISTS RELY ON EVIDENCE from clinical trials to advise their patients on what to expect when taking anti-cancer therapies. And since people may experience different outcomes despite taking the same therapy, it is especially important that patients in clinical trials reflect the diversity of patients who will receive a new treatment if it’s approved.

Unfortunately, many current clinical trials do not reflect the age, gender, or racial and ethnic diversity of the patient population. An article published June 28, 2023,  in the journal Clinical Cancer Research, published by the American Association for Cancer Research (AACR), discussed how several pharmaceutical companies and the Food and Drug Administration (FDA) are addressing this important issue. (The AACR also publishes Cancer Today.)

A large contributing factor to the lack of clinical trial diversity is that historically it has not been considered while designing trials and selecting trial sites. Planning ahead and engaging with community and patient organizations before a trial starts is a powerful way to work toward more diverse and equitable trials, as well as to increase overall participation. The FDA issued draft guidance in April 2022 to encourage companies to develop plans for enrolling more participants from underrepresented racial and ethnic populations in clinical trials. In December 2022, President Joe Biden signed legislation that requires pharmaceutical companies to submit diversity action plans for certain late-stage drug trials, including all phase III trials and most medical device studies.

The Clinical Cancer Research article summarizes a series of roundtable discussions convened by the AACR in which representatives from pharmaceutical companies shared their experiences, challenges and solutions for implementing a diversity strategy in cancer drug development. Some actions identified as helpful are:

  • Training and incorporating staff focused on diversity across all research and regulatory teams;
  • Elevating diversity to the same level of importance as other critical aspects of clinical research, such as understanding side effects;
  • Creating goals for enrolling patients and tracking progress toward meeting those goals in real time;
  • Establishing long-term partnerships with community and patient organizations to help design trials and work through hurdles to participation; and
  • Funding equipment and staff training at local health clinics to expand the number of facilities participating in research.

In addition to increasing patient representation, many of these adaptations promise to bring new therapies to routine clinical use quicker and to improve access to high-quality cancer care in historically underserved rural and urban communities.

The roundtable series and article included pharmaceutical companies because they are the primary entities accountable for improving diversity in their trials and adhering to FDA regulations. However, this is just one component of a movement that requires input and energy from the entire cancer community. The AACR intends to continue these important discussions through future publications, workshops and other events with broad stakeholders. Initiatives already underway include the AACR Cancer Disparities Progress Report published every other year, the annual AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, policy workshops and AACR Annual Meeting sessions with the FDA, and the AACR Minorities in Cancer Research Council. The AACR will continue to advocate for policies that ensure adequate representation in clinical trials, while promoting equitable access to advances in cancer therapies.

Nicholas Warren, PhD, is the assistant director, science and regulatory policy, for the American Association for Cancer Research and is a co-author of the Clinical Cancer Research article.