EFSPI/QSPI benefit-risk newsletter

Welcome to the site of the newsletter on benefit-risk jointly sponsored by the European Federation of Statisticians in the Pharmaceutical Industry Special Interest Group on Benefit-Risk (EFSPI BR SIG) and the US Society for Clinical Trials (SCT) Quantitative Sciences in the Pharmaceutical Industry (QSPI) benefit-risk working group (BRWG).Understanding the benefit-risk ratio of new medicines is at the core of drug development — from early stages through approval and reimbursement. New information constantly becomes available via the lifecycle of a medication, and the benefit-risk ratio needs to be continuously assessed. This process requires a deep understanding of the underlying data, including its strengths and limitations. Thus, statisticians play a key role in this multidisciplinary approach.

The environment is extremely complex, with many stakeholders having a different perspective. Furthermore, the development of new approaches or the advancement of available methods progresses rapidly. Here you can sign up for the newsletter and find also older newsletters.
The goal of this newsletter is to make the benefit-risk community regularly aware about the following:
  • Upcoming meetings.
  • Outcomes of initiatives.
  • New trainings.
  • Important publications.
  • Regulatory updates.
  • Other relevant informationregarding benefit-risk.

This newsletter serves as a global platform for groups and individuals working on benefit-risk to share information and get connected. This should also raise the profile of initiatives working on benefit-risk and help those who are unfamiliar with benefit-risk understand the importance of the topic, as well as support them in finding relevant information.

We hope that you will enjoy these newsletters. We welcome any information related to benefit-risk that is within the scope of our Goals for future newsletters. Please contact the editorial board for any information or article to be included.
The editorial board:
Alexander Schacht
Weili He
Qi Jiang
Ian Hirsch
Ryan Lybarger

Here is a history of published newsletters:

Newsletter #1

Newsletter #2