PMID- 34656074
OWN - NLM
STAT- MEDLINE
DCOM- 20220720
LR  - 20220912
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Linking)
VI  - 112
IP  - 2
DP  - 2022 Aug
TI  - Roadmap to 2030 for Drug Evaluation in Older Adults.
PG  - 210-223
LID - 10.1002/cpt.2452 [doi]
AB  - 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.
CI  - (c) 2021 The Authors. Clinical Pharmacology & Therapeutics (c) 2021 American Society 
      for Clinical Pharmacology and Therapeutics.
FAU - Liu, Qi
AU  - Liu Q
AUID- ORCID: 0000-0002-4053-4213
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Schwartz, Janice B
AU  - Schwartz JB
AUID- ORCID: 0000-0002-5171-7824
AD  - Departments of Medicine, Bioengineering and Therapeutic Sciences, University of 
      California San Francisco, San Francisco, California, USA.
FAU - Slattum, Patricia W
AU  - Slattum PW
AUID- ORCID: 0000-0003-1858-5089
AD  - Department of Pharmacotherapy and Outcomes Science and Virginia Center on Aging, 
      Virginia Commonwealth University, Richmond, Virginia, USA.
FAU - Lau, S W Johnny
AU  - Lau SWJ
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Guinn, Daphne
AU  - Guinn D
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Madabushi, Rajanikanth
AU  - Madabushi R
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Burckart, Gilbert
AU  - Burckart G
AUID- ORCID: 0000-0003-2005-9301
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Califf, Robert
AU  - Califf R
AUID- ORCID: 0000-0003-0231-3724
AD  - Verily and Google Health (Alphabet), South San Francisco, California, USA.
FAU - Cerreta, Francesca
AU  - Cerreta F
AUID- ORCID: 0000-0001-9316-7800
AD  - Portfolio office, European Medicines Agency (EMA), Amsterdam, The Netherlands.
FAU - Cho, Carolyn
AU  - Cho C
AD  - Oncology Early Development and Translational Research, Merck & Co., Kenilworth, 
      New Jersey, USA.
FAU - Cook, Jack
AU  - Cook J
AUID- ORCID: 0000-0001-8710-5697
AD  - Department of Clinical Pharmacology, Pfizer Global Research and Development, 
      Groton, Connecticut, USA.
FAU - Gamerman, Jamie
AU  - Gamerman J
AD  - Office of Medical Policy, Center for Drug Evaluation and Research, US Food and 
      Drug Administration, Silver Spring, Maryland, USA.
FAU - Goldsmith, Paul
AU  - Goldsmith P
AD  - Lilly Exploratory Medicine and Pharmacology, Bracknell, UK.
FAU - van der Graaf, Piet H
AU  - van der Graaf PH
AUID- ORCID: 0000-0003-1314-3484
AD  - Certara, Canterbury, UK.
FAU - Gurwitz, Jerry H
AU  - Gurwitz JH
AUID- ORCID: 0000-0003-1630-8213
AD  - Meyers Health Care Institute, a joint endeavor of University of Massachusetts 
      Medical School, Reliant Medical Group, and Fallon Health, Worcester, 
      Massachusetts, USA.
FAU - Haertter, Sebastian
AU  - Haertter S
AD  - Boehringer Ingelheim Pharma, Translational Medicine & Clinical Pharmacology, 
      Ingelheim, Germany.
FAU - Hilmer, Sarah
AU  - Hilmer S
AUID- ORCID: 0000-0002-5970-1501
AD  - Kolling Institute, University of Sydney and Royal North Shore Hospital, St. 
      Leonards, New South Wales, Australia.
FAU - Huang, Shiew-Mei
AU  - Huang SM
AUID- ORCID: 0000-0003-1354-1394
AD  - Office of Clinical Pharmacology, Office of Translational Sciences, Center for 
      Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Inouye, Sharon K
AU  - Inouye SK
AUID- ORCID: 0000-0002-3663-2937
AD  - Marcus Institute for Aging Research, Hebrew SeniorLife and Harvard Medical 
      School, Boston. Massachusetts, USA.
FAU - Kanapuru, Bindu
AU  - Kanapuru B
AD  - Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, 
      Maryland, USA.
FAU - Pirmohamed, Munir
AU  - Pirmohamed M
AUID- ORCID: 0000-0002-7534-7266
AD  - Wolfson Centre for Personalised Medicine, University of Liverpool, Liverpool, UK.
FAU - Posner, Phil
AU  - Posner P
AD  - Patient-Centered Outcomes Research Institute Ambassador, Gainesville, Florida, 
      USA.
FAU - Radziszewska, Barbara
AU  - Radziszewska B
AD  - National Institute of Aging, National Institute of Health, Bethesda, Maryland, 
      USA.
FAU - Keipp Talbot, H
AU  - Keipp Talbot H
AD  - Departments of Medicine and Public Health, Vanderbilt University Medical Center, 
      Nashville, Tennessee, USA.
FAU - Temple, Robert
AU  - Temple R
AD  - Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 
      Silver Spring, Maryland, USA.
LA  - eng
GR  - MR/L006758/1/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
DEP - 20211108
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
SB  - IM
MH  - Aged
MH  - Drug Evaluation
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/prevention & 
      control
MH  - Humans
MH  - *Polypharmacy
MH  - Prevalence
EDAT- 2021/10/17 06:00
MHDA- 2022/07/22 06:00
CRDT- 2021/10/16 20:29
PHST- 2021/03/23 00:00 [received]
PHST- 2021/10/04 00:00 [accepted]
PHST- 2021/10/17 06:00 [pubmed]
PHST- 2022/07/22 06:00 [medline]
PHST- 2021/10/16 20:29 [entrez]
AID - 10.1002/cpt.2452 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2022 Aug;112(2):210-223. doi: 10.1002/cpt.2452. Epub 2021 
      Nov 8.