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.
- 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.
Here is a history of published newsletters: