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

ABSTRACT:

Purpose

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.

Methods

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)

SUBMITTER: Leong J 

PROVIDER: S-EPMC4463867 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature