gms | German Medical Science

We are currently facing exciting times in pharmaceutical industry for statisticians. The pressure from health care systems to control their costs, the increasing investment for new therapies to bring to the market and the decreasing revenues from such new therapies puts the business model of pharmaceutical companies under severe pressure. Companies start to react now seriously by looking for new and innovative ways to change drug development, by either shortening development timelines, or reducing cost or increasing probability of success. This pressure comes today together with an increasing importance of data. More and more data per patients with new data types and more and more data from more patients become available today. There is a general hope – justified or not – that this ultimately will lead to substantial efficiency gains in drug development. This unique situation provides substantial opportunities for statisticians to demonstrate value. There is a door more open than ever to accept new methods and new thinking. But statisticians also need to be willing and able to walk through this door and demonstrate their value in such a situation. It is probably fair to say that many senior leaders in pharma do not think primarily of statistics when thinking about transforming drug development. And many statistics leaders at companies and at health authorities tend to be conservative when facing new ideas. Indeed, statisticians are great problems solvers but usually more reactive than proactive with a more conservative nature. As much as this mindset has served biostatistics well in the past, it may become more problematic in the future. This talk will describe this whole situation in more detail, the opportunities as well as the risks. It will describe obstacles for statisticians today but will also outline some potential paths forward for utilizing the many opportunities we have in front of us.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.