Over the past decade pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured systematic standardized approach. In view of this a universal framework together with an appropriate documentation system for recording benefit-risk decisions has been developed and applied and is a valuable addition to the Benefit-Risk Toolbox. The opportunity to examine the implementation of this approach by several regulatory authorities places this book in a unique position with the potential to positively contribute to the ongoing debate in this area.
The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is also reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Therefore, this is not an attempt to provide a comprehensive and complete account of the current benefit-risk assessment environment; rather, the strength of this book is that it provides an evaluation of some current approaches to the benefit-risk assessment of medicines and outlines the development of a new universal framework. It also demonstrates how a number of mature agencies have implemented this universal framework together with the methodology for documenting their benefit-risk decisions. In addition, it also reviews current publicly available documents together with their strengths and weaknesses in communicating benefit-risk decisions to stakeholders.