A Strategy for Creating Integrated Analysis Data Sets Based on ADaM Using SDTM Compliant and Noncompliant Data Sets

• Activity Number: 270
• Type: Invited
• Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Melvin Munsaka*+
• Companies: Takeda Global Research and Development, Inc.
• Keywords: ADAM ; ISS ; Safety ; CDISC

Abstract

NDA typically requires an integrated database from several protocols or studies that are included as part of the submission. The Integerated Summary of Safety is in general an essential component of a successful submission. These analyses differ from study level analysis due to larger amount of data than each study had generated prior to ISS. The creation of analysis datasets to support ISS work can be very challenging task because study data need to be converted and harmonized to the same format before initiation of programming and analysis. For ISS, the specific analyses are usually performed on predefined groupings (pooling) of studies with common elements such as common patient population, common study designs, for example, short and long term, similar patient populations, controlled vs uncontrolled studies, long terms versus short term, and so on. Differences between studies designs