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).
We welcome new members and collaborators! Please reach out to Shahrul Mt-Isa or Marco Boeri 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.
We are delighted to share the news about the recent 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.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
Date: Wednesday 5th November 2025 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Date: 19 November 2025 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
As an Associate Director Biostatistics Early Development, you will be a key member of our biostatistics group, you will play a crucial role in the design, analysis, and interpretation of clinical trials for early development programs.
If you are passionate about biostatistics and real-world data, and are looking for an exciting opportunity to contribute to groundbreaking research, we encourage you to apply.
Are you passionate about making a difference in the world of healthcare? Novartis is seeking a dynamic and experienced professional to join our team in London at The Westworks.
As the Director of HTA Biostatistics & Medical Affairs, you will play a pivotal role in shaping the future of healthcare by providing strategic biostatistical leadership and expertise.
As a Senior Principal Biostatistician, you will be responsible and accountable for all statistical work, both scientific and operational, for one or more assigned clinical trials
