Roadmap to 2030 for Drug Evaluation in Older Adults
| Autor: | Jerry H. Gurwitz, Bindu Kanapuru, Rajanikanth Madabushi, Jamie Gamerman, Francesca Cerreta, Jack Cook, Robert M. Califf, Paul Goldsmith, Daphne Guinn, Sharon K. Inouye, Robert Temple, Janice B. Schwartz, Piet H. van der Graaf, Carolyn R. Cho, Munir Pirmohamed, Barbara Radziszewska, Patricia W. Slattum, Qi Liu, Sarah N. Hilmer, Shiew-Mei Huang, H. Keipp Talbot, Phil Posner, Gilbert J. Burckart, S.W. Johnny Lau, Sebastian Haertter |
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| Rok vydání: | 2021 |
| Předmět: |
Gerontology
Aging Drug-Related Side Effects and Adverse Reactions Clinical Trials and Supportive Activities Population MEDLINE law.invention Clinical Research law Prevalence Humans Medicine Pharmacology (medical) Pharmacology & Pharmacy Dosing education Adverse effect Aged Pharmacology Polypharmacy education.field_of_study Clinical pharmacology business.industry Evaluation of treatments and therapeutic interventions Pharmacology and Pharmaceutical Sciences Brain Disorders Clinical trial 6.1 Pharmaceuticals Pharmacodynamics Drug Evaluation Patient Safety business |
| Zdroj: | Clinical pharmacology and therapeutics, vol 112, iss 2 CLINICAL PHARMACOLOGY & THERAPEUTICS |
| ISSN: | 1532-6535 0009-9236 |
| DOI: | 10.1002/cpt.2452 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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