Clinical trials in older people

Area of Science:

• Geriatric Medicine
• Clinical Trials Methodology

Background:

• Older adults are historically underrepresented in clinical medication trials.
• Exclusion is often due to age, multimorbidity, and disabilities, questioning trial external validity.
• Recruitment and retention of elderly participants present unique challenges.

Purpose of the Study:

• To highlight the challenges in conducting randomised controlled trials (RCTs) in geriatric populations.
• To emphasize the need for tailored approaches to ensure the successful participation of older adults.
• To advocate for the promotion of RCTs in geriatrics to generate reliable evidence.

Main Methods:

• Discussion of common obstacles in geriatric RCTs, including recruitment, retention, and consent.
• Exploration of methodological considerations such as blinding, intervention design, and outcome measures.
• Emphasis on the necessity of support for frail, multimorbid, or cognitively impaired participants.

Main Results:

• Older adults often have complex health profiles, differing from typical trial participants.
• Cognitive decline necessitates proxy consent, and physical/mental fatigue requires participant support.
• Potential pitfalls include participant dropout, imperfect blinding, and inappropriate outcome measures, affecting intervention effect estimation.

Conclusions:

• Successful geriatric RCTs require dedicated strategies for recruitment, retention, and participant support.
• Methodological adaptations are crucial, including relevant outcome measures and accounting for missing data.
• Promoting RCTs in geriatrics is vital for advancing the treatment, management, and care of older individuals.