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Including Older Adults in Cancer Clinical Trials: Design and Conduct Considerations

This guidance provides recommendations for including adequate representation of older adults (65 years and older, with emphasis on 75+ years) in cancer clinical trials to better evaluate the benefit-risk profile of cancer drugs in this population, which is currently underrepresented despite being a growing segment of cancer patients.

  1. Develop a comprehensive strategy for including older adults early in development planning
  2. Implement specific recruitment strategies targeting older adults
  3. Design trials with appropriate age-based stratification
  4. Include geriatric-specific assessments and outcomes measures
  5. Create a plan for monitoring and managing adverse events in older adults
  6. Establish discrete age subgroups for data analysis and reporting
  7. Consider alternative trial designs if adequate representation cannot be achieved in main trials
  8. Develop a postmarket data collection plan if needed
  9. Ensure appropriate documentation of age-related differences in labeling
  10. Engage with geriatric experts and patient advocates throughout development

Key Considerations

Clinical testing

  • Include older adults in all phases of clinical trials when safe and ethical
  • Consider age-based stratification or analyses
  • Consider alternative trial designs like open-label safety studies
  • Develop recruitment strategies targeted to older adults
  • Consider location of trial sites (community-based settings)
  • Keep clinical sites updated on enrollment progress of older adults
  • Consider remote monitoring approaches where feasible

Human Factors

  • Consider accommodations for impairments (visual, mobility)
  • Consider caregiver support needs
  • Consider format and content of informational materials

Labelling

  • Include geriatric use information unless clearly inapplicable
  • Document differences in efficacy/safety between age groups
  • Consider adding postmarket data to Geriatric Use subsection when appropriate

Safety

  • Evaluate drug interactions early in development
  • Develop strategies to capture and manage adverse events in older patients
  • Consider supportive care measures specific to older adults

Other considerations


Original guidance

  • Including Older Adults in Cancer Clinical Trials: Design and Conduct Considerations
  • HTML / PDF
  • Issue date: 2022-03-02
  • Last changed date: 2022-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Clinical - Medical, Biologics
  • ReguVirta summary file ID: 6d476038be4c01721dac73e6f93715f4
This post is licensed under CC BY 4.0 by the author.