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.
Recommended Actions
- Develop a comprehensive strategy for including older adults early in development planning
- Implement specific recruitment strategies targeting older adults
- Design trials with appropriate age-based stratification
- Include geriatric-specific assessments and outcomes measures
- Create a plan for monitoring and managing adverse events in older adults
- Establish discrete age subgroups for data analysis and reporting
- Consider alternative trial designs if adequate representation cannot be achieved in main trials
- Develop a postmarket data collection plan if needed
- Ensure appropriate documentation of age-related differences in labeling
- 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
- Document co-morbidities
- Collect additional information like geriatric assessment tools data
- Consider incorporating patient reported outcomes
- Report discrete age subgroups (65-74, 75+)
- Consider postmarket data collection if premarket representation is inadequate
- Seek input from geriatricians, geriatric oncologists, and patient advocates
Relevant Guidances
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
- Design Controls for Medical Device Manufacturers
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- Design Considerations for Medical Device Pivotal Clinical Studies
Original guidance
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