The healthcare industry is constantly developing, and with it come new regulations and guidelines that businesses must adhere to. One regulation that has recently been set in Germany is the 15% threshold for relevant improvement for some endpoints used in clinical trials. Many have critiqued this threshold. It's important for all statisticians (not only for the market access experts) to understand what it is and how it can affect drug approval. In this episode, we'll dive deep into the 15% threshold and why it's essential for statisticians beyond the market access experts to be knowledgeable about it.
We specifically discuss the following important points:
