Evidence map›Paper›PMID 32703252›Full record

ArticleTrials2020

Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA.

Ramtin Talebi, Rita F Redberg, Joseph S Ross

Open access · goldAbstract read
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Ramtin TalebiSection of Cardiovascular Medicine, Department of Medicine, University of California at San Francisco School of Medicine, San Francisco, CA, USA.
Rita F RedbergSection of Cardiovascular Medicine, Department of Medicine, University of California at San Francisco School of Medicine, San Francisco, CA, USA.
Joseph S RossSection of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA. joseph.ross@yale.edu.ORCID http://orcid.org/0000-0002-9218-3320
University of California, San Francisco · USYale New Haven Hospital · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

The FDA Amendments Act (FDAAA) required that information for certain clinical trials, such as details about study design features and endpoints, as well as results, be publicly reported in ClinicalTrials.gov . We conducted a cross-sectional analysis of phase III trials with primary results published between January 1, 2016, and June 30, 2017, in high-impact journals and found 74% contained at least one discrepancy between results reported in ClinicalTrials.gov and the corresponding publication. Our findings underscore the necessity for monitoring of clinical trial information and result reporting between sources; a checklist may provide a systemized procedure for investigators and editors to monitor accurate reporting.

Indexed as

RegistriesResearch DesignClinical Trials, Phase III as TopicCross-Sectional StudiesHumansResearch ReportUnited StatesUnited States Food and Drug AdministrationAccurate reportingClinical trial reportingFDA Amendments ActResult reporting

Identifiers

PMID32703252
PMCPMC7376878
OpenAlexW3045290767

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.