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Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: A Virtual Workshop

Completed

On January 22, 25, and 27, 2021, the National Academies convened a virtual workshop—sponsored by the Food and Drug Administration—on the challenges and opportunities to improve the evidence base for treating older adults with cancer. Presentations and panel discussions examined the root causes that limit enrollment of older adults in cancer clinical trials and strategies for improved inclusion of older adults across the drug development continuum.

Description

A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and host a 1.5-day public workshop to examine challenges and opportunities to improve the evidence base for treating older adults with cancer. The workshop will feature invited presentations and panel discussions on topics such as:

  • The root causes that limit enrollment of older adults in clinical trials for oncology (and other disciplines such as cardiology and pulmonology), and strategies to mitigate those barriers;
  • Strategies for inclusion of older adults in early phase studies (e.g., pharmacokinetic, pharmacodynamic, and in vitro studies that describe dose-response, concentration-response, and drug-drug and drug-disease interactions) that can inform the development of later phase studies;
  • Clinical trial design and analysis strategies that could encourage and facilitate enrollment of older adults in cancer clinical trials (e.g., decentralization of clinical trial sites, broadening eligibility criteria, and offering caregiver support);
  • Opportunities to incorporate geriatric assessments and patient reported outcomes into clinical trial designs; and
  • Strategies to collect real world data via observational studies or registries to improve the collection of postmarket safety and efficacy data on newly approved drugs.

A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

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