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A practical approach to communicating benefit-risk decisions of medicines to stakeholders

Overview of attention for article published in Frontiers in Pharmacology, June 2015
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Title
A practical approach to communicating benefit-risk decisions of medicines to stakeholders
Published in
Frontiers in Pharmacology, June 2015
DOI 10.3389/fphar.2015.00099
Pubmed ID
Authors

James Leong, Stuart Walker, Sam Salek

Abstract

The importance of a framework for a systematic structured assessment of the benefits and risks has been established, but in addition, it is necessary that the benefit-risk decisions and the processes to derive those decisions are documented and communicated to various stakeholders for accountability. Hence there is now a need to find appropriate tools to enhance communication between regulators and other stakeholders, in a manner that would uphold transparency, consistency and standards. A retrospective, non-comparative study was conducted to determine the applicability and practicality of a summary template in documenting benefit-risk assessment and communicating benefit-risk balance and conclusions for reviewers to other stakeholders. The benefit-risk (BR) Summary Template and its User Manual was evaluated by 12 reviewers within a regulatory agency in Singapore, the Health Sciences Authority (HSA). The BR Summary Template was found to be adequate in documenting benefits, risks, relevant summaries and conclusions, while the User Manual was useful in guiding the reviewer in completing the template. The BR Summary Template was also considered a useful tool for communicating benefit-risk decisions to a variety of stakeholders. The use of a template may be of value for the communicating benefit-risk assessment of medicines to stakeholders.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 15 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 15 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 4 27%
Lecturer 2 13%
Student > Master 2 13%
Student > Ph. D. Student 2 13%
Unspecified 1 7%
Other 2 13%
Unknown 2 13%
Readers by discipline Count As %
Medicine and Dentistry 4 27%
Pharmacology, Toxicology and Pharmaceutical Science 3 20%
Environmental Science 2 13%
Social Sciences 1 7%
Unspecified 1 7%
Other 2 13%
Unknown 2 13%
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 11 June 2015.
All research outputs
#20,656,820
of 25,374,647 outputs
Outputs from Frontiers in Pharmacology
#9,981
of 19,717 outputs
Outputs of similar age
#206,133
of 280,844 outputs
Outputs of similar age from Frontiers in Pharmacology
#35
of 63 outputs
Altmetric has tracked 25,374,647 research outputs across all sources so far. This one is in the 10th percentile – i.e., 10% of other outputs scored the same or lower than it.
So far Altmetric has tracked 19,717 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.3. This one is in the 37th percentile – i.e., 37% 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 280,844 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 14th percentile – i.e., 14% of its contemporaries scored the same or lower than it.
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 17th percentile – i.e., 17% of its contemporaries scored the same or lower than it.