ArticleBritish journal of clinical pharmacology2019
Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
41 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Temporal changes in characteristics and external validity of randomized controlled trials in older people from 2012 to 2019.BMC geriatrics · 2023Pooled it
- Potentially inappropriate prescribing and its associations with health-related and system-related outcomes in hospitalised older adults: A systematic review and meta-analysis.British journal of clinical pharmacology · 2021Pooled it
- The underreporting of phase III chemo-therapeutic clinical trial data of older patients with cancer: A systematic review.Journal of geriatric oncology · 2020Pooled it
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- Therapeutic Drug Monitoring in Special Circumstances in Inflammatory Bowel Disease.Journal of clinical medicine · 2025Review
- How Clinical Pharmacology Can Support Clinical Trial Diversity and Inclusion.Clinical and translational science · 2025Review
- Potential Drug Dose-Specific Adverse Three-Drug Combinations: A US Insurance Claims Data-Based Study.Pharmacoepidemiology and drug safety · 2025Article
- Leveraging In Silico and Artificial Intelligence Models to Advance Drug Disposition and Response Predictions Across the Lifespan.Clinical and translational science · 2025Review
- Augmenting Insufficiently Accruing Oncology Clinical Trials Using Generative Models: Validation Study.Journal of medical Internet research · 2025Article
- Prescription of Strong Opioids in Chronic Non-Cancer Pain in the Province of Valladolid (Spain).Life (Basel, Switzerland) · 2025Article
- Complications and comorbidities associated with antineoplastic chemotherapy: Rethinking drug design and delivery for anticancer therapy.Acta pharmaceutica Sinica. B · 2024Review
- Bayesian interim analysis for prospective randomized studies: reanalysis of the acute myeloid leukemia HOVON 132 clinical trial.Blood cancer journal · 2024Article
- Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review.NIHR open research · 2024Article
- Impact of Advanced Age on the Incidence of Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes Mellitus and Stable Coronary Artery Disease in a Real-World Setting in Spain.Journal of clinical medicine · 2023Article
- Optimal medical therapy after percutaneous coronary intervention in very elderly patients with coronary artery disease.International journal of cardiology. Cardiovascular risk and prevention · 2023Article
- Review
- Intratumoral immunotherapy of murine pheochromocytoma shows no age-dependent differences in its efficacy.Frontiers in endocrinology · 2023Article
- Real-world Impact of Age at Diagnosis on Treatment Patterns and Survival Outcomes of Patients with Metastatic Pancreatic Ductal Adenocarcinoma.The oncologist · 2022Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate the availability of pharmacokinetic, safety and efficacy analyses specifically targeted at elderly, prior to the authorization of drugs.
methodsA cross-sectional, structured review of publicly available initial approval documents of Food and Drug Administration-approved drugs was performed. The 10 most frequently on-label prescribed drug classes, drugs with known pharmacokinetic differences in the elderly or drugs that are relatively contraindicated in elderly (e.g. anticholinergics or benzodiazepines) were included in the analyses.
resultsIn total, 1129 unique active pharmaceutical ingredients were found eligible for the analyses, of these, 506 were found in the Food and Drug Administration database (45%). The initial approval documents were available for 182 drugs. For the majority of the drugs, the initial approval documents in the database showed information on pharmacokinetics in elderly (n = 113; 62%). Furthermore, over time, the availability of information with regard to elderly increased statistically significantly from 0% in the period 1970-1979 to 76% for the period 2010-2018. Information on safety and efficacy was less frequently present, i.e. 42% and 45%, respectively and, moreover, the availability of information did not improve over time.
conclusionThe under-representation of elderly in clinical trials thereby challenging the external validity of benefit/risk assessments of launched drugs was confirmed. Priority should be given to a study population that is representative for the target population.
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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.