A Scientific Obligation: Supporting the Research Process with Complete, Documented Data

• Activity Number: 568
• Type: Contributed
• Date/Time: Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Steven Kirby*+ and Aleksandra Stein
• Companies: Celerion Corporation and Celerion Corporation
• Keywords: Data Standards ; Metadata ; CDISC ; SDTM ; ADaM

Abstract

Conclusions not supported by data are just opinions. Scientists in many disciplines are working to generate standards for how scientific data should be delivered to end users. As scientists who support subject matter experts across all scientific disciplines, Statisticians are uniquely qualified to help the scientific community better define what makes data useful and accessible. With data more easily collected, shared and analyzed than ever, it is important for statisticians to help lead the discussion on how best to form general requirements for scientific data.

The increasingly formalized data requirements associated with the US drug development process (based on FDA guidance and data standards from the CDISC consortium) will be reviewed to highlight basic characteristics of data that solidly support scientific conclusions. How standards for the delivery of scientific data and associated documentation have been practically implemented across disciplines will be investigated, and the strengths and weaknesses of existing approaches will be evaluated. We conclude that education and outreach on general standards for useful data is needed; possible approaches are discussed.