Roadmap to 2030 for Drug Evaluation in Older Adults



Liu, Qi, Schwartz, Janice B, Slattum, Patricia W, Lau, SW Johnny, Guinn, Daphne, Madabushi, Rajanikanth, Burckart, Gilbert, Califf, Robert, Cerreta, Francesca, Cho, Carolyn
et al (show 15 more authors) (2022) Roadmap to 2030 for Drug Evaluation in Older Adults. CLINICAL PHARMACOLOGY & THERAPEUTICS, 112 (2). pp. 210-223.

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Abstract

Changes that accompany older age can alter the pharmacokinetics (PK), pharmacodynamics (PD), and likelihood of adverse effects (AEs) of a drug. However, older adults, especially the oldest or those with multiple chronic health conditions, polypharmacy, or frailty, are often under-represented in clinical trials of new drugs. Deficits in the current conduct of clinical evaluation of drugs for older adults and potential steps to fill those knowledge gaps are presented in this communication. The most important step is to increase clinical trial enrollment of older adults who are representative of the target treatment population. Unnecessary eligibility criteria should be eliminated. Physical and financial barriers to participation should be removed. Incentives could be created for inclusion of older adults. Enrollment goals should be established based on intended treatment indications, prevalence of the condition, and feasibility. Relevant clinical pharmacology data need to be obtained early enough to guide dosing and reduce risk for participation of older adults. Relevant PK and PD data as well as patient-centered outcomes should be measured during trials. Trial data should be analyzed for differences in PK, PD, effectiveness, and safety arising from differences in age or from the presence of conditions common in older adults. Postmarket evaluations with real-world evidence and drug labeling updates throughout the product lifecycle reflecting new knowledge are also needed. A comprehensive plan is needed to ensure adequate evaluation of the safety and effectiveness of drugs in older adults.

Item Type: Article
Uncontrolled Keywords: Humans, Polypharmacy, Prevalence, Drug Evaluation, Aged, Drug-Related Side Effects and Adverse Reactions
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 14 Apr 2022 14:12
Last Modified: 18 Jan 2023 21:05
DOI: 10.1002/cpt.2452
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3152894