Objectives

• To understand and leverage Benefit-Risk methodologies for efficient and effective decision-making
• To collaborate across industry, academia, and public bodies and across geographies to provide recommendations on key methodological issues across product life cycles
• To increase use and acceptance of Benefit-Risk methodologies with case study examples
• To disseminate external information to the broader community with conferences, workshops, seminars, and publications
• To implement safety methodology >Link to Safety Methodology Implementation Group 

Who we are

The Benefit-Risk ESIG was formed in 2012 with the vision to ensure industry professionals understood and effectively utilize Benefit-Risk methods throughout the entire medicinal product lifecycle process. The group is open to professionals from industry, academia, and public bodies (including regulatory and HTA agencies). Within BRSIG 2024, the "Safety Methodology Implementation Group" was established.

How to get in touch

 We welcome new members and collaborators! Please reach out to Mounir Aout or Benjamin Knöferl if you have an interest in being involved in this ESIG, or have an interesting case study or experience of carrying out a structured Benefit-Risk assessment to share.

News/Upcoming events

PSI conference 2026

Session "Advancing the Implementation of Safety Methodologies" (Chair: Naomi Givens (GSK))

• Quantitative Evolution of Drug Safety: Adapting Inventions to Innovations
  Dooti Roy (Boehringer-Ingelheim)
• Beyond SUSARs: The Statistical Art of Aggregate Safety Reporting
  Matthias Trampisch (Boehringer-Ingelheim)
• Pooling, Grouping, Adjusting: A Statistician’s Toolkit for Integrated Summary of Safety development  
  Florence Le Maulf (Cytel)

Highlights from 2025

In 2025, the EFSPI/PSI Benefit‑Risk Assessment ESIG focused on strengthening engagement and setting a clear strategic direction for the future. A central activity was the revision and development of a new BRESIG Blueprint, updating the original 2013 document to articulate a shared vision for the coming years. The emphasis was on clarifying scope, priorities, and intended outputs to guide medium‑term activities.

The revised blueprint identified key focus areas including patient preferences in benefit‑risk assessment, safety and tolerability methodology implementation, review of benefit‑risk guidances, and partnerships with external working groups. The ESIG adopted a pragmatic, implementation‑oriented approach, prioritising practical experiences, case studies, and knowledge‑sharing formats such as seminars and webinars alongside methodological work.

A major development in 2025 was the establishment of focused working groups aligned with this vision. In particular, the Safety Implementation working group, led by Naomi Givens, was created to address the practical adoption of novel safety and tolerability methodologies. The group began defining priority topics and committed to presenting its work at the PSI Conference Belfast in June 2026.

What Benefit-Risk is about

The group had provided comments to the draft report and we are delighted to share the publication of the CIOMS Working Group XII report on Benefit-Risk Balance for Medicinal Products in May 2025. 

This report provides insights into the methods used to evaluate the benefit-risk (BR) balance of a medicinal product. A favourable BR profile must be established for all medicinal products prior to marketing. This balance must be reassessed periodically in the post-marketing setting when new information regarding the benefits and risks, or the landscape of their application, becomes available. Two new points of emphasis include: (1) transitioning benefit-risk evaluation from a post-hoc exercise to a comprehensively integrated element of clinical trial design and conduct, and (2) a pragmatic patient-centric approach to benefit-risk assessment to ensure proper reflection and evaluation of the benefits and harms as experienced by patients. This report builds on the foundations of the CIOMS Working Group IV report published in 1998, and entitled: Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals; and expands to BR management throughout a product’s lifecycle using structured approaches and updated methodologies. Presentations on the report and its recommendations at various scientific conferences and webinar series are being planned and are subject to future communications.