Leveraging the Adam Standard for Therapeutic Area Standards

• Activity Number: 280
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Susan Kenny*+
• Keywords: ADaM ; Data Standards ; Therapeutic Area Standards ; CDISC ; CFAST

Abstract

The Analysis Data Model (ADaM) is a CDISC data standard specifically developed for statistical analyses and reporting. The model specifies standard structures that are predictable yet flexible enough to accommodate a variety of analysis situations. For example, the ADaM model for time to event (TTE) has a predictable structure and standard variables yet is agnostic with respect to therapeutic area (TA). Therefore, this one model can be used for any type of data for which TTE analyses are performed. To date, the materials developed by the joint venture of CDISC/C-Path/and TransCelerate to support the FDA's goal of the development and implementation of TA standards have focused largely on data collection standards. This presentation will illustrate how the use of the ADaM standard can extend this effort into TA standards for analysis data. Using the TTE model as a working example we will discuss how the development of ADaM controlled terminology and consistent use of standard variables can support the goal of TA standards. We will illustrate how additional features of the ADaM standard can be leveraged to support clear communication between industry and regulatory agencies.