270 – CDISC - Marching Ahead by Facing Challenges: A Pharmaceutical Industry Experience
A Strategy for Creating Integrated Analysis Data Sets Based on ADaM Using SDTM Compliant and Noncompliant Data Sets
Melvin Munsaka
Takeda Global Research and Development, Inc.
A New Drug Application (NDA) typically requires an integrated database from several protocols or studies that are included as part of the submission. The Integrated Summary of Safety is in general an essential component in the review of a submission. These types of analysis differ from study level analysis primarily due to large amount of data that each study had generated prior to preparation of the Integrated Summary of Safety (ISS) or Integrated Analysis of Safety (IAS). The creation of analysis datasets to support ISS work is often very challenging because study data need to be converted and harmonized to the same format before initiation of programming and analysis. For the ISS, the specific analyses are usually performed based on predefined groupings (pooling) of studies with common elements, such as common patient population or common study designs, for example, short and long term, controlled versus uncontrolled studies, titration versus fixed dose, randomized versus non-randomized, and so on. Differences between studies designs, treatment regimens, duration of exposure, and patient populations can create barriers to data integration and can also lead to challenges in reliable interpretation and conclusions of the accumulated information. This paper will discuss a strategy to create an integrated database for safety analysis that is ADaM driven, using both SDTM and company standards as source data to the ISS database.
