FDA’s Draft Guidance Promotes Diversity in Clinical Trials, ASCO Says in New Comments

August 6, 2019

ASCO recently submitted comments to the Food and Drug Administration (FDA) regarding the agency’s draft guidance recommending specific approaches for sponsors of clinical trials to broaden eligibility criteria, redesign clinical trials, and remove patient barriers to increase enrollment of underrepresented populations in their clinical trials.

ASCO urges the FDA to require that sponsors provide a strong clinical and/or scientific justification for excluding trial participants from the trial protocol. ASCO applauds the FDA for the many recommendations included in this draft guidance and previous guidances which align to recommendations ASCO and the Friends of Cancer Research put forward as a way to improve collection of trial data that are more relevant to the real-world population of people with cancer.

The FDA’s draft guidance outlines various trial designs, such as expansion cohorts and adaptive clinical trials, for sponsors to consider to make clinical trials easier for sites and patients. ASCO supports these recommendations, however it suggests the FDA provide more specific guidance in certain areas to ensure patient safety.

The society’s comment letter also outlines ASCO’s support of the FDA’s recommendations to:

  • Make trial participation less burdensome for participants, including financial assistance for expenses associated with the costs incurred by participation in clinical trials (e.g. travel, childcare, lodging). Many of these barriers were identified in ASCO’s statement to address financial barriers to clinical trial participation.
  • Reduce the frequency of study visits, through eliminating redundant testing and leveraging electronic communication and mobile technologies whenever appropriate.
  • Encourage trial sponsors to involve patients, patient advocates, and caregivers in the design of clinical trial protocols.
  • Improve the geographic diversity of clinical trial sites and to explore agreements to foster inter-site exchange of medical records for purposes of participant retention.
  • Re-enroll patients from early-phase trials into later-phase trials when studying the effectiveness of treatments, particularly in rare diseases, in limited circumstances when medically appropriate and without safety issues.

ASCO’s comments also note the society’s ongoing efforts to improve diversity through oncology community awareness/engagement, improving clinical research practice, addressing patient cultural/contextual factors, and improving insurance coverage for clinical trials.

Read the full comment letter.

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