ArticleAnnals of internal medicine2016
ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.
Article in Annals of internal medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 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
39 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Industry sponsorship and research outcome.The Cochrane database of systematic reviews · 2017Pooled it
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- In silico methods for drug-target interaction prediction.Cell reports methods · 2025Review
- InterPAD is a database of drug-drug interaction between phytochemicals and anticancer drugs.Scientific reports · 2025Article
- State of Geographic Access to Cancer Treatment Trials in the United States: Are Studies Located Where Patients Live?JCO oncology practice · 2025Article
- Clinical trial registration in India: 12% of drug regulatory trials are not registered, as required by law.Health research policy and systems · 2025Article
- Constructing a finer-grained representation of clinical trial results from ClinicalTrials.gov.Scientific data · 2024Article
- INTEDE 2.0: the metabolic roadmap of drugs.Nucleic acids research · 2024Article
- VARIDT 3.0: the phenotypic and regulatory variability of drug transporter.Nucleic acids research · 2024Article
- ADCdb: the database of antibody-drug conjugates.Nucleic acids research · 2024Article
- Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match.Frontiers in medicine · 2024Article
- Comparison of Reporting and Transparency in Published Protocols and Publications in Umbrella Reviews: Scoping Review.Journal of medical Internet research · 2023Article
- Does type of funding affect reporting in network meta-analysis? A scoping review of network meta-analyses.Systematic reviews · 2023Article
- DrugMAP: molecular atlas and pharma-information of all drugs.Nucleic acids research · 2023Article
- Chinese Clinical Trial Registry 13-year data collection and analysis: geographic distribution, financial support, research phase, duration, and disease categories.Frontiers in medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundPharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. PURPOSE: To validate results posted on ClinicalTrials.gov against publicly available U.S. Food and Drug Administration (FDA) reviews on Drugs@FDA. DATA SOURCES: ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical and statistical reviews). STUDY SELECTION: 100 parallel-group, randomized trials for new drug approvals (January 2013 to July 2014) with results posted on ClinicalTrials.gov (15 March 2015). DATA EXTRACTION: 2 assessors extracted, and another verified, the trial design, primary and secondary outcomes, adverse events, and deaths.
resultsMost trials were phase 3 (90%), double-blind (92%), and placebo-controlled (73%) and involved 32 drugs from 24 companies. Of 137 primary outcomes identified from ClinicalTrials.gov, 134 (98%) had corresponding data at Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results. Most differences were nominal (that is, relative difference <10%). Primary outcome results in 14 trials could not be validated. Of 1927 secondary outcomes from ClinicalTrials.gov, Drugs@FDA mentioned 1061 (55%) and included results data for 367 (19%). Of 96 trials with 1 or more serious adverse events in either source, 14 could be compared and 7 had discordant numbers of persons experiencing the adverse events. Of 62 trials with 1 or more deaths in either source, 25 could be compared and 17 were discordant. LIMITATION: Unknown generalizability to uncontrolled or crossover trial results.
conclusionPrimary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half the secondary outcomes, as well as serious events and deaths, could not be validated because Drugs@FDA includes only "key outcomes" for regulatory decision making and frequently includes only adverse event results aggregated across multiple trials. PRIMARY FUNDING SOURCE: National Library of Medicine.
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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.