The Role of Pre-Specification in Clinical Assessment

The EU HTA will not only affect all statisticians in the pharmaceutical industry with respect to skill sets and collaboration (we talked about that in podcast #3), but will also have an impact on the economic modeling that is needed for the reimbursement and pricing decisions in many European countries. Understanding the influence of the joint clinical assessment on economic modeling, the relationship between estimands and PICOs as well as the pre-specification of statistical analyses and their use in economic modeling is becoming much more important for statisticians in the near future.

In this episode, we will talk about the role of economic modeling in the HTA process, and the influence of the EU HTA, and the corresponding statistical analyses on that process.