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Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov

Overview of attention for article published in Accountability in Research, July 2015
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Title
Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov
Published in
Accountability in Research, July 2015
DOI 10.1080/08989621.2015.1020375
Pubmed ID
Authors

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

Abstract

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 (7-October-2012) and screened for eligibility (phase 2-4, interventional, recruitment closed, results available, first received for registration after 10-November-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<0.001). 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.

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The data shown below were collected from the profiles of 5 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 12 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 12 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 2 17%
Student > Ph. D. Student 2 17%
Student > Doctoral Student 2 17%
Librarian 1 8%
Other 1 8%
Other 2 17%
Unknown 2 17%
Readers by discipline Count As %
Medicine and Dentistry 3 25%
Arts and Humanities 2 17%
Pharmacology, Toxicology and Pharmaceutical Science 1 8%
Agricultural and Biological Sciences 1 8%
Psychology 1 8%
Other 3 25%
Unknown 1 8%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 5. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 08 July 2016.
All research outputs
#6,963,672
of 25,374,647 outputs
Outputs from Accountability in Research
#239
of 437 outputs
Outputs of similar age
#74,629
of 275,577 outputs
Outputs of similar age from Accountability in Research
#6
of 10 outputs
Altmetric has tracked 25,374,647 research outputs across all sources so far. This one has received more attention than most of these and is in the 72nd percentile.
So far Altmetric has tracked 437 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 17.3. This one is in the 45th percentile – i.e., 45% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 275,577 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 72% of its contemporaries.
We're also able to compare this research output to 10 others from the same source and published within six weeks on either side of this one. This one has scored higher than 4 of them.