CHAI leader to discuss key data considerations for implementing adaptive trials
Adaptive trials are a critical component in accelerating the drug development process.
While advanced analytics and agile operations are certainly critical factors in the successful implementation of adaptive approaches, these core capabilities cannot be successful without a strong data management strategy, says David Handelsman, Senior Manager, Advanced Analytics Strategy in the Center for Health Analytics and Insights at SAS.
Handelsman will discuss key data considerations for successful adaptive trial implementations during the ADAPT 2011 congress September 7-9 in Philadelphia.
“Biopharmaceutical companies continue to aggregate research data as each clinical trial is completed, but that data is minimally used beyond the primary goals of proving the hypothesis for a single trial and, where necessary, supporting the submission of a marketing application,” Handelsman says. “Only recently have companies begun to manage their legacy clinical trials data so it can be used to drive advanced scientific and business decisions, such as those identified through modeling and simulation.”
"Such use of historic data, however, is not sufficient for successful adaptive trials," he adds. "Additionally, a timely data capture and cleansing process must be put into place to enable the successful execution of the adaptive design."
During the session, Handelsman will describe strategies to address the use of legacy data in driving trial design and the timely use of ongoing trial data in executing adaptively designed trials.