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Clinical trial registration and reporting: a survey of academic organizations in the United States

Overview of attention for article published in BMC Medicine, May 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)
  • Good Attention Score compared to outputs of the same age and source (75th percentile)

Mentioned by

news
7 news outlets
twitter
36 tweeters

Citations

dimensions_citation
25 Dimensions

Readers on

mendeley
30 Mendeley
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Title
Clinical trial registration and reporting: a survey of academic organizations in the United States
Published in
BMC Medicine, May 2018
DOI 10.1186/s12916-018-1042-6
Pubmed ID
Authors

Evan Mayo-Wilson, James Heyward, Anthony Keyes, Jesse Reynolds, Sarah White, Nidhi Atri, G. Caleb Alexander, Audrey Omar, Daniel E. Ford

Abstract

Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and social desirability, this could be a "best case" scenario. Before the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Twitter Demographics

The data shown below were collected from the profiles of 36 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 30 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 30 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 6 20%
Researcher 4 13%
Unspecified 2 7%
Student > Bachelor 2 7%
Student > Ph. D. Student 2 7%
Other 3 10%
Unknown 11 37%
Readers by discipline Count As %
Medicine and Dentistry 8 27%
Nursing and Health Professions 3 10%
Unspecified 2 7%
Agricultural and Biological Sciences 1 3%
Pharmacology, Toxicology and Pharmaceutical Science 1 3%
Other 2 7%
Unknown 13 43%

Attention Score in Context

This research output has an Altmetric Attention Score of 66. 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 20 November 2019.
All research outputs
#551,612
of 22,881,154 outputs
Outputs from BMC Medicine
#410
of 3,438 outputs
Outputs of similar age
#13,982
of 325,659 outputs
Outputs of similar age from BMC Medicine
#13
of 48 outputs
Altmetric has tracked 22,881,154 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 3,438 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 43.6. This one has done well, scoring higher than 88% 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 325,659 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 48 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 75% of its contemporaries.