Benefit-Risk SIG

The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.

The main aims of the SIG are:

• To understand how best to apply Benefit-Risk methodologies across the Pharmaceutical Industry
• To discuss and make recommendations on key methodological issues
• To share examples of how Benefit-Risk has been used within pharmaceutical companies
• To share external information including new developments around Benefit-Risk

Currently the SIG has subgroups working on:

• Literature review
• Benefit-Risk in the HTA setting (together with the HTA SIG)
• Bayesian applications in Benefit-Risk
• Preference elicitation and Benefit-Risk

We also develop relevant training in the area of structured Benefit-Risk as needed.

If you have an interest in being involved in this SIG, or have an interesting case study or experience of carrying out a structured Benefit-Risk assessment to share, please contact Maria Costa (email: maria_j.costa@novartis.com)

Our BLOG can be found under www.benefit-risk-assessment.com. It is a great source of information for all things Benefit-Risk related: upcoming conferences, journal publications, training, and much more.

Latest News

PSI - Advances in 2018
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Statistical Excellence in the Pharmaceutical Industry

We are now accepting entries for the 2019 awards
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Future Events

PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 11 – 11 Jun, 2019

In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.

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Adaptive Designs - Dates: 24 – 24 Jun, 2019

During this meeting we will hear about adaptive sample allocation for phase II/III designs, a new CONSORT extension reporting guideline for adaptive designs, regulatory aspects and case studies.

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