Benefit-Risk ESIG (BRESIG)

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

Who are we

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).

How to get in touch

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.

Latest news

We are attending the PSI Conference 2023 in Hammersmith, London. We look forward to seeing you there!

Join us at the Welcome Reception on Sunday evening June 11th and at our session “Small Steps Towards Patient Focused Benefit-Risk Assessment” on Monday June 12th (11:00 – 12:30)!

2023 Focus

 

Upcoming events


 

Small Steps Towards Patient Focused Benefit-Risk Assessment”

Monday June 12, 2023 (11:00 – 12:30) 

Chaired by Martin Gebel – Introduction to BRESIG and “re-launch” of BRESIG

Preference-based Benefit-Risk Assessment [Shahrul Mt-Isa]

Introduces what “preference-based benefit-risk assessment” (pBRA) means, why should we care, and how they characterise and frame BRA for a better transparency and accuracy

Benefit-Risk Assessment in Clinical Trials with Composite Endpoints [Ursula Garczarek]

Presents options for BR composite endpoints, encourages debates on their pros and cons, and discusses the role that they can play in the overall BRA in drug development

Sample Size Calculations for Discrete Choice Experiments in Pharmaceutical and Health Care Applications [Marco Boeri]

Presents technical aspects and shift focus thinking when determining the sample size in preference studies to overcome the challenges in recruiting a large number of patients

 


Upcoming Events

PSI Training Course: Introduction to Machine Learning

This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.

Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

This webinar will explore two different approaches to Correlates of Protection in vaccine development.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

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.

PSI Webinar: Drug Development in Women's Health

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.

PSI Webinar: Surrogacy

This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.

PSI Career Young Virtual Event (Q2 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Statistician, Data Science

We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.