Statistics plays an important role in drug development. Its use is necessary for planning and analysing trials and using statistics correctly is crucial for the success of drug development programs. While statistics is therefore undoubtedly essential for drug development, the importance of statisticians, as trained experts in this field is often overlooked. In a paper from 2002 A.P Grieve asked, ‘Do statisticians count?’ and pointed out, that the statistician’s worth in drug development is often underappreciated. One reason for this is certainly that there is a lack of knowledge about what a statistician in this area is actually doing and what challenges he or she is facing everyday.

In the IDEAS network we are in the unique position to see the statistician’s role in drug development from many different perspectives, since our network comprises partners from both industry and academia and many members have experience as/with regulators. To gain further insight into the responsibilities and challenges a statistician in this area is facing today we conducted a survey, asking experts in the field for their opinion. We sent out our survey to many different institutions and in total we received 34 responses, 19 from pharmaceutical companies and 9 from academia with the remaining 6 coming from other institutions like research centers and hospitals. These blog posts were written based on the answers we received. Therefore they do not represent our own personal opinions, but rather the views of our survey’s participants.

With this series of blog posts we want to provide an overview of drug development from a statistician’s point of view. Each post will cover one phase of the drug development process, from pre-clinical to Phase III. We hope that this series will give non-statisticians working in the area an insight into the statistician’s point of view. We also aim to inform statisticians working in other fields, as well as aspiring statisticians, who might consider choosing a career in drug development. The link to the blog post related to Pre-clinical phase is given below:

Pre-clinical phase

Phase I

Phase II

Phase III