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) Summary Template and its User Manual was evaluated by 12 reviewers within a regulatory agency in Singapore, the Health Sciences Authority (HSA).Results: 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.Conclusions: The use of a template may be of value for the communicating benefit-risk assessment of medicines to stakeholders.
Highlights
Regulators are challenged to review the overall balance between the benefits and the associated risks of new drugs rather than the impact of individual components (Breckenridge, 2010)
The overall study package including the study protocol, BR Summary Template, User Manual (Supplementary Material) and the study evaluation tool (Supplementary Material) was sent to 16 clinical reviewers in Health Sciences Authority (HSA) involved in assessing the benefit-risk balance and registration of medicines
The reviewers transferred the relevant information required for the BR Summary Template from their respective completed clinical assessment reports with the support of the User Manual
Summary
Regulators are challenged to review the overall balance between the benefits and the associated risks of new drugs rather than the impact of individual components (Breckenridge, 2010). In this context, the key components for effective regulation are transparency and accountability underpinned by the use of a structured framework that aids in the communication of the differences in opinion between regulators and the drug developers (World Health Organization, 2003). Commenting on innovations in regulatory science, Leufkens and Eichler suggested that there are three dimensions in Communicating benefit-risk decisions this area. It is likely that a new overarching framework would be required to encompass these new initiatives
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