Roadmap to 2030 for Drug Evaluation in Older Adults

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.

Physiologically‐Based Pharmacokinetic Modelling to Investigate Baricitinib and Tofacitinib Dosing Recommendations for COVID‐19 in Geriatrics

“… 23 Addressing this challenge by the FDA, a workshop hosted in 2020, entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults,” thoroughly discussed the deficits in the evaluation of drugs in clinical trials for older adults who are often accompanied by multiple chronic health conditions, polypharmacy, or frailty. 11 The under‐representation of this cohort sets similar barriers for making adequate decisions on optimal drug therapy of patients with COVID‐19.…”

Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019

“…32 Closing the gaps in clinical trial enrollment of older adults will require engagement of multiple stakeholders, including researchers and scientific societies, regulatory bodies, health care providers, older adults and caregivers, and health care payers. 5 Most prior studies have analyzed enrollment in clinical trials by individual patient characteristics and or individual treatment indications, and the definition for older adults has not been consistent over time. 24,26,28,31 In 2015, the FDA established the Drug Trials Snapshots (DTS) website to show the participation of patients in trials that supported the approval of drugs and biologics by age, sex, and race.…”

“…A clinical trial ecosystem needs to be developed to acquire and provide this information so that it can be used to optimize prescribing at the time of introduction of drugs into clinical care. 5…”

Diversity in Clinical Pharmacology Coming of Age

“…1 The latter is the topic of a series of articles in the current issue of CPT, which covers therapeutic treatment and evaluation in patient groups across the full age range, from preterm infants to geriatrics (Figure 1). [2][3][4][5][6] On one end of the patient age spectrum, Engbers et al 2 examine the exposure-response relationship of ibuprofen on closure of the patent ductus arteriosus in preterm infants. Their model-based analysis provides new insights into the role of ibuprofen exposure, covariates, and timing of treatment on clinical outcomes.…”