Using ADaM Standard Analysis Data: Challenges and Progress

• Activity Number: 280
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Stephen E. Wilson*+
• Companies: FDA/CDER
• Keywords: CDISC ; ADaM ; Analysis Data Standards ; Statistical Regulatory Review

Abstract

With the fifth Prescription Drug Users Fee Act (PDUFAV) in 2013, the Center for Drug Evaluation and Research demonstrated its commitment to employing Clinical Data Interchange Standards Consortium (CDISC) data standards for the submission and regulatory review of new drugs and biologics. The Analysis Data Model (AdaM) describes the CDISC standards for the creation of the analysis files. CDER's "Study Data Specifications, V2.0" document encourages applicants to submit ADaM datasets for regulatory review. A number of sponsor companies have risen to the challenge of creating and submitting ADaM datasets.

A primary motivation for the development of analysis data standards has been "the need for transparency of communication with and scientifically valid review by regulatory agencies." It seems that "transparency" and "communication" should be fundamental requirements for all high quality statistical research activities. The development and application of these standards is a "work in progress." This presentation will describe what has been accomplished and what remains to be done to establish and use ADaM standards for regulatory review.