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.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC