J.M. (Joyce) Hoek, MSc

My PhD research is part of the project Back to Bayesics: Solving the Replication Crisis in Biomedicine, which focuses on the reanalysis of clinical trial data with new Bayesian statistics tools. My role in this project is to study the current practices of medicine approval.

Before a new medicine can be put on the market and used by people, it needs to be approved by a regulatory authority. These regulators have the difficult task to decide if the benefits of a drug outweigh its risks. In my research, I will reflect on the normative question of what might constitute a good decision to accept or reject a drug by looking at the current practices and developments of regulatory decision-making.

One aspect that drug regulators base their decisions on is the available scientific evidence that shows if a drug is effective or not. Traditionally, this evidence is generated using randomized controlled trials (RCTs) and evaluated using a statistical method called null hypothesis significance testing, but this way of evidence generation is changing. New types of evidence that do not rely on the traditional RCT are becoming more prevalent, and in the recent replication crisis of biomedicine the current way of using statistics has been questioned. My research will therefore specifically focus on what scientific evidence for efficacy is, how it changes, and what it does in the drug regulatory process.