ArticleBMJ open2017
Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.
Article in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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
8 citing papers in PubMed.
- A Scoping Review of Case-Level Causality Assessment Tools Developed Between 2008 and 2023; Strengths, Weaknesses and Potential Future Improvements.Drug safety · 2026Article
- Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.Pharmaceutical medicine · 2026Article
- Comparison of drug approvals of the FDA and EMA between 2013 and 2023.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023.Pediatric reports · 2025Article
- US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.Clinical trials (London, England) · 2021Article
- On-Label and Off-Label Clinical Studies of FDA-Approved Ophthalmic Therapeutics.Ophthalmology · 2021Article
- Patient burden and clinical advances associated with postapproval monotherapy cancer drug trials: a retrospective cohort study.BMJ open · 2020Article
- Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.JAMA network open · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
objectivesTo characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency. DESIGN AND
settingCross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010. Regulatory documents from both agencies were used. PRIMARY AND SECONDARY OUTCOME MEASURES: All identified postmarketing studies were classified according to planned enrolment, funding, status and geographical location, and we determined whether studies studied the originally approved indication.
resultsOverall, 69 novel drugs approved between 2005 and 2010 were eligible for inclusion. A total of 6679 relevant postmarketing studies were identified; 5972 were interventional (89.4%). The median number of studies per drug was 55 (IQR 33-119) and median number of patients to be enrolled per study was 60 (IQR 28-183). Industry was the primary sponsor of 2713 studies (40.6%) and was a primary or secondary sponsor in 4176 studies (62.5%). In all, 2901 studies (43.4%) were completed, 487 (7.3%) terminated, 1013 (15.2%) active yet not recruiting, 1895 (28.4%) recruiting and 319 (4.8%) not yet recruiting. A total of 80% of studies were conducted in only one country and 84.4% took place in Europe and/or North America; 2441 (36.5%) studied another indication than the originally approved indication. Studies designed in the originally approved indication were found to be more industry-sponsored than others 68.7%vs53.7%; P<0.0001.
conclusionsPostmarketing pharmaceutical research was highly variable and predominantly located in North America and Europe. Postmarketing studies were frequently designed to study indications other than the originally approved one. Although some findings were reassuring, others question the lack of coordination of postmarketing research.
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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.