A New Paradigm for Clinical Trials Afforded by Emerging Technologies

• Activity Number: 60
• Type: Invited
• Date/Time: Monday, August 12, 2002 : 8:30 AM to 10:20 AM
• Sponsor: Section on Statistical Consulting*
• Author(s): Stephen Ruberg*+
• Affiliation(s): Eli Lilly and Company
• Keywords: Clinical Trials ; Data-Acquisition ; eClinical ; Informatics ; Data Analysis ; Real-Time Data

Abstract

The abundance of ever-growing databases coupled with real-time data acquisition allows for many new approaches to clinical drug development. The impact can be seen in all aspects of clinical trials, from study set-up to study execution to study analysis and reporting. This has tremendous impact on the use of statistics for the design and analysis of clinical data.

Statisticians will have access to large medical and health information databases from which to test assumptions and define patient populations for inclusion in a clinical trial. Adaptive designs will be more practical to execute with the real-time flow of data from investigative clinics to the statistician. Electronic medical records will allow greater inclusion of "naturalistic" data into formal analysis of clinical data. Smart analysis and reporting tools will allow for easier communication of results and documentation for regulatory agency review.

Statisticians will be challenged to adapt their thinking and their methodologies to capitalize on the "brave new world" that is emerging from the tremendous growth in electronic technologies.