Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov

Serina Stretton; Rebecca A Lew; Julie A Ely; Mark J Snape; Luke C Carey; Cassandra Haley; Mark J Woolley; Karen L Woolley

doi:10.1080/08989621.2015.1020375

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Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov

Journal article

Peer reviewed

Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov

Serina Stretton, Rebecca A Lew, Julie A Ely, Mark J Snape, Luke C Carey, Cassandra Haley, Mark J Woolley and Karen L Woolley

Accountability in Research, Vol.23(2), pp.67-78

2016

DOI: https://doi.org/10.1080/08989621.2015.1020375

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Abstract

clinical trials as topic

drug industry

publications

registries

We investigated whether sponsor-imposed publication restrictions for ClinicalTrials.gov trials were reasonable, based on consistency with Good Publication Practice 2 (GPP2). ClinicalTrials.gov trial record data were electronically imported (October 7, 2012) and screened for eligibility (phase 2-4, interventional, recruitment closed, results available, first received for registration after November 10, 2009, any sponsor type, investigators not sponsor employees). Two authors categorized restrictions information as consistent or not consistent with GPP2, resolving discrepancies by consensus. Of the eligible trials (388/484, n = 81,768 participants), 80.7% (313/388) had restrictions disclosed, and 92.5% (311/388) were industry-sponsored. Significantly more trials had restrictions that were consistent with GPP2 than not (74.1% [232/313], n = 55,280 participants vs. 25.9% [81/313], n = 19,677 participants; P < .001). Reasons for inconsistency were insufficient, unclear, or ambiguous information (48.1%, 39/81), sponsor-required approval for publication (35.8%, 29/81), sponsor-required text changes (8.6%, 7/81), and outright bans (7.4%, 6/81). Follow-up of trials with insufficient information and a contact email (response rate, 46.9% [15/32]) revealed 2 additional bans. A total of 776 participants had consented to trials that had publication bans. Many, but not all, sponsor-imposed publication restrictions disclosed on ClinicalTrials.gov may be considered reasonable. Sponsors should ensure restrictions are appropriately disclosed. Volunteers should be alerted to any restrictions before consenting to participate in a clinical trial.

Details

Title: Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov
Authors: Serina Stretton (Author) - ProScribe-Envision Pharma Group
Rebecca A Lew (Author) - ProScribe-Envision Pharma Group
Julie A Ely (Author) - ProScribe-Envision Pharma Group
Mark J Snape (Author) - ProScribe-Envision Pharma Group
Luke C Carey (Author) - ProScribe-Envision Pharma Group
Cassandra Haley (Author) - ProScribe-Envision Pharma Group
Mark J Woolley (Author) - ProScribe-Envision Pharma Group
Karen L Woolley (Author) - University of the Sunshine Coast - Faculty of Science, Health, Education and Engineering
Publication details: Accountability in Research, Vol.23(2), pp.67-78
Publisher: Taylor & Francis Inc.
Date published: 2016
DOI: 10.1080/08989621.2015.1020375
ISSN: 0898-9621
Organisation Unit: UniSC Clinical Trials Centre; University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy
Language: English
Record Identifier: 99449259502621
Output Type: Journal article

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