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PROTECT Benefit-Risk Group is a collaboration amongst private and public sector partners. Read more about our expert members

Our experience has been distilled into a clear set of practical recommendations for benefit-risk decision processes and supporting tools, organised around five generic stages. Read more about our recommendations.

Methodologies related to benefit-risk assessment fall into four categories. To learn more about them, click here.

Frameworks are guidelines to conducting benefit-risk assessment for good decision-making practice and to increase transparency. Read more about frameworks.

Tables, although simple, are flexible tools for displaying benefits and risks. Structured tables summarise in one place all the benefits and risks data that drive the decision. See more tables.

Interactive visual displays enable active participation of the audience, which can increase attention and perception, as well as can be personalised to individuals. See more.

There are many reasons why it is desirable to engage patients and members of the public (PPI) in regulatory decision-making, either through consultation or collaboration. Read more about PPI.

Welcome to the PROTECT Benefit-Risk Website

PROTECT, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium, contains a number of work programmes whose goal is to strengthen the monitoring of the benefit-risk balance of medicines in Europe and to enhance early detection and assessment of adverse drug reactions from different data sources.
The evaluation of the balance between benefits and risks of drugs is fundamental to numerous stakeholders including patients, healthcare providers, health technology assessors, regulators and biopharmaceutical companies. Decision-making with regards to benefit-risk assessment is often complex. It is important to ensure transparent, robust and comprehensive methodologies are used, and also that patient and public preferences on benefits and risks feed into the decision-making process.

Decision Makers - Who are they?

To achieve these goals, the PROTECT Benefit-Risk group has developed a clear set of practical recommendations for benefit-risk decision processes and supporting tools, which we hope will serve as a valuable guide for readers who are new to the world of benefit-risk assessment. These recommendations highlight key issues and considerations that are common to many approaches and benefit-risk decision problems

For clarity, these practical recommendations are organised around the five stages of a generic benefit-risk assessment roadmap.

The generic benefit-risk assessment roadmap is underpinned by earlier reports from the Benefit-Risk group. To read the summary findings from the reports, click on the respective boxes below.

PROTECT Benefit-Risk Group Disclaimer

The processes described and conclusions drawn from the work presented herein relate solely to the testing of methodologies and representations for the evaluation of benefit and risk of medicines. This report neither replaces nor is intended to replace or comment on any regulatory decisions made by national regulatory agency, nor the European Medicines Agency.