Pharmaceutical Industry Statisticians: Moving Forward with Challenges

• Activity Number: 472
• Type: Topic Contributed
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section on Physical and Engineering Sciences
• Author(s): Vipin Arora*+
• Companies: AbbVie, Inc.
• Keywords: Pharmaceutical ; Guidance ; Adaptive Designs ; Industry ; Statisticians

Abstract

Industry Statisticians play a strategic role in decision making that often include business aspects. Statistical methodology is heavily utilized to plan and implement measures that are key components to the overall development plan. These methodologies can be flexible for certain type of industries but not for all, e.g., limited, if any, flexibility exists for late stage development programs in the Pharmaceutical Industry. Those programs often require either an up-front buy in from regulatory agencies or they must work within pre-specified guidance. These limitations can create challenges in the implementation of the projects including conducting, analyzing and interpreting data from clinical studies especially late stage clinical trials where the effect size, as well as the choice of existing options for treatment and/or management of the underlying condition are likely to shift during the development program. There have been steps in the right direction including FDA's draft guidance on Adaptive Designs and data sharing on key results from clinical studies via CT.gov. Sharing and learning information can optimize drug development to ensure safe and effective treatments.