New FDA Guidance Seeks to Increase Older Adults Participation in Cancer Clinical Trials

May 12, 2020

The Association for Clinical Oncology (ASCO) recently submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s draft guidance to encourage the inclusion of older adults in clinical trials of cancer drug treatments.

People aged 65 years and older experience the majority of cancer diagnoses and deaths and make up the majority of cancer survivors, however since older adults are not well represented in clinical trials, there’s little evidence on how to treat this population. Instead, oncologists extrapolate from trials conducted in younger, healthier populations.

ASCO believes that clinical trials should include older adults with cancer when they can be safely and ethically enrolled, and commends FDA for releasing this draft guidance. ASCO recommends the final guidance include the following: 

  • Sponsors should be required to 1) expand work with oncologists in non-academic sites to provide opportunities where more older patients are likely to seek treatment and 2) work with social and behavioral scientists, patient advocates/navigators, geriatricians, and geriatric oncologists to consider the needs of older adults when designing clinical trials.
  • Sponsors should discuss their plans for enrolling older adults with FDA staff, particularly when enrollment may be challenging.
  • FDA should consider post-marketing commitments for companies that fail to follow these plans and/or achieve adequate numbers of older adults in their registration trials.
  • Sponsors should implement the eligibility criteria recommendations developed by ASCO and Friends of Cancer Research, with involvement of FDA and the National Cancer Institute (NCI) and provide a rationale if the recommended criteria cannot be adopted.
  • Trial sponsors should report detailed age distribution (by decade) of the population included in the study and conduct stratified analysis for age groups aged 65 years and older and 75 years and older to understand the drug’s benefits and risk in all older adults.
  • Sponsors should collect data on a broader population, including older adults, in the post-market setting and use real-world data in studies, registries, or secondary data analysis.
  • More evidence should be included in the drug label describing use in older adults to aid in the safe and effective use of therapeutics and better inform treatment decisions.

Read the full comment letter.

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