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Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents

Overview of attention for article published in Frontiers in Pharmacology, December 2014
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Title
Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
Published in
Frontiers in Pharmacology, December 2014
DOI 10.3389/fphar.2014.00269
Pubmed ID
Authors

Leong Wai Yeen, James, Salek, Sam, Walker, Stuart

Abstract

The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

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The data shown below were collected from the profile of 1 X user 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 11 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 11 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 4 36%
Student > Ph. D. Student 1 9%
Student > Bachelor 1 9%
Student > Master 1 9%
Unknown 4 36%
Readers by discipline Count As %
Social Sciences 2 18%
Arts and Humanities 1 9%
Pharmacology, Toxicology and Pharmaceutical Science 1 9%
Economics, Econometrics and Finance 1 9%
Nursing and Health Professions 1 9%
Other 2 18%
Unknown 3 27%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. 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 04 December 2014.
All research outputs
#20,245,139
of 22,772,779 outputs
Outputs from Frontiers in Pharmacology
#9,999
of 16,011 outputs
Outputs of similar age
#302,151
of 360,768 outputs
Outputs of similar age from Frontiers in Pharmacology
#42
of 63 outputs
Altmetric has tracked 22,772,779 research outputs across all sources so far. This one is in the 1st percentile – i.e., 1% of other outputs scored the same or lower than it.
So far Altmetric has tracked 16,011 research outputs from this source. They receive a mean Attention Score of 4.9. This one is in the 1st percentile – i.e., 1% of its peers scored the same or lower than it.
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We're also able to compare this research output to 63 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.