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Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability

Overview of attention for article published in BMC Medicine, September 2018
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  • In the top 5% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (95th percentile)
  • High Attention Score compared to outputs of the same age and source (86th percentile)

Mentioned by

news
5 news outlets
blogs
1 blog
policy
1 policy source
twitter
11 X users

Citations

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22 Dimensions

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mendeley
34 Mendeley
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Title
Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability
Published in
BMC Medicine, September 2018
DOI 10.1186/s12916-018-1154-z
Pubmed ID
Authors

Ashley M. Hopkins, Andrew Rowland, Michael J. Sorich

Abstract

Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical industry 2 years after publication of the primary results. PubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the pharmaceutical industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union. Fifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity.

X Demographics

X Demographics

The data shown below were collected from the profiles of 11 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 34 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 34 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 5 15%
Professor > Associate Professor 3 9%
Student > Ph. D. Student 3 9%
Student > Postgraduate 2 6%
Researcher 2 6%
Other 5 15%
Unknown 14 41%
Readers by discipline Count As %
Medicine and Dentistry 7 21%
Pharmacology, Toxicology and Pharmaceutical Science 4 12%
Business, Management and Accounting 2 6%
Mathematics 1 3%
Nursing and Health Professions 1 3%
Other 4 12%
Unknown 15 44%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 60. 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 21 December 2022.
All research outputs
#642,505
of 23,881,329 outputs
Outputs from BMC Medicine
#461
of 3,613 outputs
Outputs of similar age
#14,830
of 343,463 outputs
Outputs of similar age from BMC Medicine
#11
of 73 outputs
Altmetric has tracked 23,881,329 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 97th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 3,613 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 44.6. This one has done well, scoring higher than 87% of its peers.
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 343,463 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 95% of its contemporaries.
We're also able to compare this research output to 73 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 86% of its contemporaries.