Evidence map›Paper›PMID 26269118›Full record

ArticleBMC medicine2015

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.

Eve Tang, Philippe Ravaud, Carolina Riveros, Elodie Perrodeau, Agnes Dechartres

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 16 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

58 citing papers in PubMed, 16 syntheses or guidelines pooled it.

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  11. Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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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

5 authors.

Eve TangColumbia University, Mailman School of Public Health, New York, NY, USA. eveystang@gmail.com.
Philippe RavaudColumbia University, Mailman School of Public Health, New York, NY, USA. philipperavaud@gmail.com.
Carolina RiverosCentre de Recherche Epidémiologie et Statistique, Inserm U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France. carolina.riveros@aphp.fr.
Elodie PerrodeauCentre de Recherche Epidémiologie et Statistique, Inserm U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France. elodie.perrodeau@gmail.com.
Agnes DechartresCentre de Recherche Epidémiologie et Statistique, Inserm U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France. agnes.dechartres@aphp.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe reporting of serious adverse events (SAEs) in clinical trials is crucial to assess the balance between benefits and risks. For trials with serious adverse events posted at ClinicalTrials.gov, we assessed the consistency between SAEs posted at ClinicalTrials.gov and those published in corresponding journal articles.

methodsAll records from ClinicalTrials.gov up to February 2014 were automatically exported in XML format. Among these, we identified all phase III or IV randomized controlled trials with at least one SAE posted. For a random sample of 300 of these trials, we searched for corresponding publications using MEDLINE via PubMed and extracted safety results from the articles.

resultsAmong the sample of 300 trials with SAEs posted at ClinicalTrials.gov, 78 (26%) did not have a corresponding publication, and 20 (7%) had a publication that did not match the ClinicalTrials.gov record. For the 202 remaining trials, 26 published articles (13%) did not mention SAEs, 4 (2%) reported no SAEs, and 33 (16%) did not report the total number of SAEs per treatment group. Among the remaining 139 trials, for 44 (32%), the number of SAEs per group published did not match those posted at ClinicalTrials.gov. For 31 trials, the number of SAEs was greater at ClinicalTrials.gov than in the published article, with a difference ≥30 % for at least one group for 21. Only 33 trials (11%) had a publication reporting matching numbers of SAE and describing the type of SAE.

conclusionsMany trials with SAEs posted at ClinicalTrials.gov are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with ClinicalTrials.gov. These results underline the need to consult ClinicalTrials.gov for more information on serious harms.

Indexed as

Clinical Trials as TopicDrug-Related Side Effects and Adverse ReactionsPublicationsPublishingAccess to InformationAdverse Drug Reaction Reporting SystemsHumansResearch DesignSeverity of Illness Index

Identifiers

PMID26269118
PMCPMC4535304

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.