Evidence map›Paper›PMID 22920226›Full record

ArticleTrials2012

Sponsors' participation in conduct and reporting of industry trials: a descriptive study.

Andreas Lundh, Lasse T Krogsbøll, Peter C Gøtzsche

Abstract read
In one paragraph

Article in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Industry sponsorship and research outcome.The Cochrane database of systematic reviews · 2017
    Pooled it
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  3. Trial
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  5. Review
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  9. What Constitutes an Independent Statistical Analysis?Journal of general internal medicine · 2018
    Review
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  11. Article
  12. Article
  13. Article
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  15. West Meets East.Kidney diseases (Basel, Switzerland) · 2015
    Article
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  17. Review
  18. Article
  19. Article
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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.

Andreas LundhThe Nordic Cochrane Centre, Rigshospitalet, Dept. 7811, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. al@cochrane.dk
Lasse T Krogsbøll
Peter C Gøtzsche

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBias in industry-sponsored trials is common and the interpretation of the results can be particularly distorted in favour of the sponsor's product. We investigated sponsors' involvement in the conduct and reporting of industry-sponsored trials.

methodsWe included all industry-sponsored trials published in The Lancet in 2008 and 2009 and corresponding trial protocols provided by The Lancet. For each protocol and publication, we extracted information on trial conduct and reporting.

resultsWe identified 169 publications of randomised trials and included 69 (41%) that were industry-sponsored, and 12 (7%) industry-funded but seemingly independently conducted as a subsample. Entry of data into the study database was done independently by academic authors without the involvement of the sponsor or a contract research organisation in one of the 69 trials. Two trials had independent data analysis and one independent reporting of results. In 11 of the trials, there was a discrepancy between the information in the protocols and papers concerning who analysed the data. In four of the 12 seemingly independent trials, the protocol described sponsors' involvement in writing the report while the published paper explicitly stated that the sponsor was not involved.

conclusionsThe sponsors are usually involved in the analysis and reporting of results in industry-sponsored trials, but their exact role is not always clear from the published papers. Journals should require more transparent reporting of the sponsors' role in crucial elements such as data processing, statistical analysis and writing of the manuscript and should consider requiring access to trial protocols, independent data analysis and submission of the raw data.

Indexed as

Interdisciplinary CommunicationInterinstitutional RelationsPeriodicals as TopicResearch DesignAuthorshipBiasBibliometricsConflict of InterestCooperative BehaviorData Interpretation, StatisticalDrug IndustryEndpoint DeterminationHumansPublication BiasRandomized Controlled Trials as TopicResearch Support as Topic

Identifiers

PMID22920226
PMCPMC3502592

What OpenQuestion holds

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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.