What is the current role of statistics in medical product development, and what trends will we see in statistics moving forward? The January issue of Therapeutic Innovation & Regulatory Science featured a forward-looking collection of manuscripts to provide insight into these questions.
As Dr. Rick Turner notes in his commentary in the January issue of the journal:
“The series is noteworthy in that it embodies a lifecycle approach to drug development, an important approach that enables rational decision making when moving from one phase of development to another. Discussions of studies throughout the preapproval continuum are presented. Second, it embraces statistical methodologies for evaluating drug safety during both development and therapeutic use. It is fair to say that until relatively recently, analytical methods for efficacy data have been more well developed than those for safety data, in large part due to the contrast in the nature of endpoints of interest: therapeutic confirmatory trials typically have just one or two efficacy endpoints, while ‘‘safety data are multidimensional and complex.’ It is therefore gratifying that the last two papers in the series address this extremely important domain.”
To further the discussion, the journal’s Section Editor for Statistics, Richard Zink (Principal Research Statistician Developer in the JMP Life Sciences Division at SAS Institute), sat down with fellow Editorial Board member Rick Turner (Senior Scientific Director, Quintiles Communications), to record a podcast about how the Special Issue evolved, and what they see as the future of statistics.