Evidence map›Paper›PMID 24687070›Full record

ArticleAnnals of internal medicine2014

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

Daniel M Hartung, Deborah A Zarin, Jeanne-Marie Guise, Marian McDonagh, Robin Paynter, Mark Helfand

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of internal medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 123 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 20 pooled it
–field-weighted citation impact
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

123 citing papers in PubMed, 20 syntheses or guidelines pooled it.

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  17. Industry sponsorship and research outcome.The Cochrane database of systematic reviews · 2017
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63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Daniel M Hartung
Deborah A Zarin
Jeanne-Marie Guise
Marian McDonagh
Robin Paynter
Mark Helfand

Funding

ClinicalTrial Registration and Results ReportingZIALM008926 · NLM · NATIONAL LIBRARY OF MEDICINE · PI ZARIN, DEBORAH · 2009 to 2014
$4.3M
Oregon Comparative Effectiveness Research K12 ProgramK12HS019456 · AHRQ · OREGON HEALTH & SCIENCE UNIVERSITY · PI GUISE, JEANNE-MARIE · 2010 to 2010
$2.1M
Oregon Institute for Comparative EffectivenessKM1CA031878 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI GUISE, JEANNE-MARIE, MORRIS, CYNTHIA D · 2010 to 2010
$496k
AHRQ HHS K12 HS019456Intramural NIH HHSNCI NIH HHS KM1 CA031878
6 · The paper itself

Abstract

backgroundClinicalTrials.gov requires reporting of result summaries for many drug and device trials. PURPOSE: To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature. DATA SOURCES: ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases. STUDY SELECTION: 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups. DATA EXTRACTION: One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified. DATA SYNTHESIS: Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication. LIMITATION: Small sample that included earliest results posted to the database.

conclusionReporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Indexed as

Clinical Trials as TopicDatabases, FactualDrug-Related Side Effects and Adverse ReactionsHumansPeer Review, Research

Identifiers

PMID24687070
PMCPMC4617780

What OpenQuestion holds

Textmetadata
LicenceTDM
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.