The Good, the Bad, and the Ugly: The Pharmaceutical Industry Perspective with CDISC Data Standards
*Peter Mesenbrink, Novartis Pharmaceuticals Corporation 

Keywords: data standards, data transparency, meta-analysis, exploratory data analysis

Awareness of the importance of end-to-end CDISC data standards has grown multifold over the past five years among statisticians in the pharmaceutical industry. However, it is not always clear to all the magnitude of the impact that can be made with high quality analytical decision making as part of CDISC data standards development and implementation. In an era with data transparency across Pharma, the development of disease-area CDISC data standards not only impacts the quality of the NDA/BLA review but also impacts comparative effectiveness research as part of pricing and reimbursement and exploratory data analysis and the planning of future clinical trials through meta-analysis. Experiences where development and implementation have been done well and suboptimally will be discussed and what needs to be done as part of collaboration between industry and FDA statisticians to ensure that we are able to maximize the use of standardized data in the future.