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Published on: September 20, 2020
Drug trials for older people
1George Institute for Global Health, Sydney, Australia. richard.lindley@sydney.edu.au
As the global population ages, drug trials must include older adults and frail individuals to ensure medications are safe and effective for everyone. New research is needed to bridge evidence-practice gaps in geriatric pharmacotherapy.
Area of Science:
- Gerontology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- The global population is experiencing unprecedented aging.
- Over a billion older adults are projected within decades.
- Current drug trials inadequately represent older populations, leading to evidence-practice gaps.
Purpose of the Study:
- To highlight the need for inclusive drug trial criteria.
- To advocate for the inclusion of older adults and frail individuals in clinical studies.
- To address the lack of evidence regarding drug efficacy and safety in the aging population.
Main Methods:
- Review of current practices in randomized controlled trials (RCTs).
- Identification of age and frailty exclusion criteria in existing studies.
- Proposal for modifications in future RCT design.
Main Results:
- Significant evidence-practice gaps exist due to the exclusion of older and frail individuals from drug trials.
- Inappropriate age limits and exclusion of frail participants are common in RCTs.
- Current drug efficacy and safety data are insufficient for the aging demographic.
Conclusions:
- Abolish age limits in new randomized controlled trials.
- Routinely measure frailty in older adult participants.
- Conduct new RCTs to validate treatment effectiveness and safety in elderly and frail populations.
- Prioritize research ensuring drug efficacy for older individuals.
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