ArticleBMJ (Clinical research ed.)2018
Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.
Article in BMJ (Clinical research ed.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
42 citing papers in PubMed, 1 synthesis or guideline pooled it.
- New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.Drug safety · 2022Pooled it
- Assessment of United States Food and Drug Administration Approval of Cell and Gene Therapies.Clinical pharmacology and therapeutics · 2026Article
- Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016-2024.Clinical trials (London, England) · 2026Article
- Reporting and Publication of Postmarket Clinical Trials for Novel Drugs Approved by the FDA.JAMA network open · 2026Article
- Article
- Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study.PLoS medicine · 2025Article
- High-Throughput Computing to Detect Harmful Drug-Drug Interactions in Older Adults: Protocol for a Population-Based Cohort Study.JMIR research protocols · 2025Article
- Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices.Medical decision making : an international journal of the Society for Medical Decision Making · 2025Article
- Article
- Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information.Frontiers in drug safety and regulation · 2025Article
- Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence.BMJ open · 2024Article
- Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies.JAMA network open · 2024Article
- Use of the Therapy App Prescinde for Increasing Adherence to Smoking Cessation Treatment.Healthcare (Basel, Switzerland) · 2023Article
- Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics.JAMA network open · 2023Article
- Transparency of Results Reporting in Cancer Clinical Trials.JAMA network open · 2023Article
- Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.Journal of general internal medicine · 2022Article
- Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.Clinical pharmacology and therapeutics · 2022Article
- Pharmacists' Knowledge and Perceptions of FDA Approval Standards and the Breakthrough Therapy Designation.Pharmacy (Basel, Switzerland) · 2022Article
- Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis.Clinical trials (London, England) · 2022Article
- Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.JAMA health forum · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
objectivesTo characterize postmarketing requirements for new drugs and biologics approved by the US Food and Drug Administration (FDA), and to examine rates and timeliness of registration, results reporting, and publication of required prospective cohort studies, registries, and clinical trials.
designCross sectional analysis.
settingPostmarketing requirements for all new drugs and biologics approved by the FDA between 1 January 2009 and 31 December 2012, with follow-up up to 15 November 2017.
main outcome measuresPostmarketing requirements and their characteristics known at the time of FDA approval, including FDA authority, study design, and study characteristics. Rates and timeliness of registration and results reporting on ClinicalTrials.gov and publication in peer reviewed journals of required prospective cohort studies, registries, and clinical trials.
resultsBetween 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one postmarketing requirement at the time of first approval, for a total of 437 postmarketing requirements. Postmarket study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) postmarketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies. Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomization, comparator type, allocation, outcome, and number of patients to be enrolled, respectively. Of 134 required prospective cohort studies, registries, and clinical trials, 102 (76.1%) were registered on ClinicalTrials.gov; of 50 registered and completed studies, 36 (72.0%) had reported results on ClinicalTrials.gov. Among 65 completed studies, 47 (72.3%) had either reported results or were published a median of 47 months (interquartile range 32-67) after FDA approval. 32 (68.1%) of these 47 studies did not report results publicly by the time of their original FDA report submission deadline.
conclusionsPostmarketing requirements for new drugs and biologics were often briefly described and did not contain enough information to characterize study designs. Approximately three quarters of postmarketing requirements for prospective cohort studies, registries, and clinical trials were registered on ClinicalTrials.gov, and nearly three quarters of completed studies reported results or were published, suggesting that at least a quarter of these required studies are not being publicly disseminated.
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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.