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.
What You Need to Know? 👇
What are the key FDA recommendations for including older adults in cancer clinical trials?
FDA recommends enrolling representative populations of older adults (65+) in all trial phases, developing targeted recruitment strategies, using flexible trial designs like age-based stratification, and collecting additional geriatric assessment data to better understand benefit-risk profiles in this population.
How should medical device companies adapt cancer trial designs to better include patients 75 years and older?
Companies should consider age-based stratification, hierarchical testing strategies, parallel safety arms for older adults, and alternative trial designs when pivotal trials cannot enroll representative samples. Remote monitoring and community-based sites can improve accessibility for older participants.
What specific data collection requirements does FDA recommend for older adults in cancer trials?
Beyond age and performance status, FDA recommends collecting geriatric assessment elements including functional status, cognitive function, comprehensive comorbidity assessments, and patient-reported outcomes. More discrete age subgroups (65-74 and 75+) should be analyzed separately.
How can digital health solutions support older adult participation in cancer clinical trials?
Digital solutions should address accessibility challenges through user-friendly interfaces, remote monitoring capabilities, caregiver support features, and accommodations for visual or mobility impairments. Content format and delivery methods should be tailored for older adult preferences and capabilities.
What postmarket strategies does FDA recommend when older adults are underrepresented in premarket trials?
FDA suggests postmarket trials with broader populations, real-world data collection through observational studies or registries, and prospective discussion with review divisions. This data can inform labeling updates in the Geriatric Use subsection when clinically appropriate.
How should adverse event monitoring differ for older adults in cancer device trials?
Older adults may experience different adverse events than younger patients. Companies should develop specific strategies for capturing and managing these events, including supportive care measures and involvement of geriatric specialists to facilitate trial completion.
What You Need to Do 👇
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
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies
- 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