I’m pretty excited as I was asked to present about benefit-risk at the first EFPSI workshop on regulatory statistics. The organizers have built a very good agenda with lots of good content and presenters.
I’ll talk after David Wright from the MHRA, who will give a regulatory perspective on the evolution of BR and the regulatory decision process. Georg Quartey (Roche) will speak after me about a variety of case studies. Thus, I’m in the middle. We agreed, that each presenter will have 20 minutes to speak and that the session will end with a 30 minutes podium discussion.
The goal of my presentation is to provide the perspective off an industry statistician on benefit-risk. I’m thinking especially about those statisticians, that rarely touched this topic in the past. My draft title is “What’s happening in benefit-risk and what is our role as a statistician?”
My current plan for the content is to talk about
- Overview of BR
- What is a framework?
- What is quantitative vs qualitative?
- What are the different initiatives in this field?
- Stakeholders like NICE, ISPOR, ….
- Patient initiatives and other ongoing topics (IMI projects)
- What is the role of the statistician?
- What is the EFSPI/PSI special interest group on benefit-risk doing?
- What are the recommendations regarding simple steps that everybody could do?
If you are new to this topic, would that be something, that you would like to hear about or is there something else? If you have already some expertise or experience in the benefit-risk area, would you add something different? Regarding my last point – what recommendations would you have?
Please leave a comment and I promise, that I will reply!