ArticleJAMA network open2022
Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019.
Article in JAMA network open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Representation of Older Adults and Women in Randomized Trials of Noninvasive Imaging for Chest Pain.Circulation. Cardiovascular imaging · 2025Pooled it
- Scales used to assess ageism in the health care sector: a (COSMIN) systematic review of the measurement properties.BMC geriatrics · 2025Pooled it
- The effect of down-titration and discontinuation of heart failure pharmacotherapy in older people: A systematic review and meta-analysis.British journal of clinical pharmacology · 2025Pooled it
- Efficacy and safety of antidepressants for pain in older adults: A systematic review and meta-analysis.British journal of clinical pharmacology · 2024Pooled it
- Trends in Patient Representation in Low Back Pain Pharmacological Randomized Clinical Trials, 2011 to 2020: A Systematic Review.The journal of pain · 2024Pooled it
- Long-acting intranasal insulin for the treatment of delirium-a randomised clinical trial.Age and ageing · 2025Trial
- Health and Social Care Interventions in the 80 years Old and Over Population: An Evidence and Gap Map.Campbell systematic reviews · 2026Review
- Examining HbA1c in Frail Older Adults: A Linked Data Cohort Study.Australasian journal on ageing · 2026Article
- Recruitment and Participation of Black Home Health Care Patients in Speech-Based Cognitive Research: Mixed Methods Feasibility Study.JMIR formative research · 2026Article
- Aging promotes a RAGE-dependent increase in breast cancer metastasis.Communications biology · 2026Article
- Physicians' gender and specialty in relation to adverse drug reaction reporting in Sweden.European journal of clinical pharmacology · 2026Observational
- Closing the gap of older adult recruitment to cancer clinical trials: a scoping review.BMC cancer · 2026Article
- Predictors of Clinical Trial Participation Among Older U.S. Adults With Multimorbidity: A Cross-Sectional Survey.Clinical and translational science · 2026Article
- Quantification of Age and Sex Ratio Differences between Trial and Target Population for New Drugs.Clinical pharmacology and therapeutics · 2026Article
- Embracing the Digital Revolution: How Artificial Intelligence is Transforming Clinical Trials in Older Participants.Drugs & aging · 2026Review
- Article
- Age-related prognoses in a Luxembourgish breast cancer cohort.Frontiers in oncology · 2026Article
- Machine learning-based mortality risk prediction model for elderly diabetic patients with non-ST-segment elevation myocardial infarction using MIMIC-IV database.Scientific reports · 2025Article
- Surgery for Older Cancer Patients: Cross-Organ Review and Good Practice Statement by the Japanese Geriatric Oncology Guideline Committee.Annals of gastroenterological surgery · 2025Review
- Representation of Older Adult Patients in Clinical Trials.Clinical and translational science · 2025Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Importance: Older age may be accompanied by changes in the pharmacokinetics or pharmacodynamics or both of medications that can result in altered safety and efficacy profiles. Objective: To assess representation of older adults in clinical trials of new drug applications (NDAs) and biologics license applications (BLAs). Design, Setting, and Participants: This cross-sectional study analyzed US Food and Drug Administration (FDA) data for NDAs and BLAs approved from 2010 through 2019. Age distribution of clinical trial participants was compared with age distribution of the US population with the disease or disorder (prevalent population). Data were from adults enrolled in registration trials for depression, heart failure, insomnia, non-small cell lung cancer (NSCLC), nonvalvular atrial fibrillation (NVAF) stroke prevention, osteoporosis, and type 2 diabetes or adults sampled from US prevalent population in community-dwelling health data. Data were analyzed from November 2020 to February 2021. Exposures: Trial enrollment. Main Outcomes and Measures: Representativeness of trial populations was assessed by the participation to prevalence ratio (PPR) defined as the percentage of patients by age group among clinical trial participants to the percentage of patients by age group among US prevalent population. Results: Data from 166 clinical trials (229 558 participants) for 44 NDAs and BLAs were analyzed. The most consistent finding was the limited enrollment of the oldest age groups, namely those 75 years and above for type 2 diabetes and NSCLC, and 80 years and above for NVAF stroke prevention, insomnia, heart failure, and osteoporosis. Adults aged 60 to 74 years were enrolled in equal or greater proportion than the US prevalent population. Conclusions and Relevance: In this cross-sectional study, underrepresentation of the oldest adults existed during evaluation of new drugs and biologics, yet the older adults may represent significant proportions of the treatment population. Closing the representation gap between clinical trial enrollment and potential treatment populations is essential for safe and effective use of new drugs and biologics.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.