Sharing Data and Models to Improve Clinical Drug Development and Regulatory Decisions
Venue: Washington Marriott Hotel
Location: Washington, District Of Columbia, United States
Event Date/Time: Jan 24, 2007 | End Date/Time: Jan 25, 2007 |
Description
•Better understanding of prior information in making current drug development and approval decisions
•Better understanding of disease through biomarkers
•Application of modern bioinformatics to mine prior knowledge (e.g., NDAs) sources
Oftentimes, useful prior clinical trial information that could improve drug development efficiency is lost within companies and at the FDA. This information could help us to better understand the biomarker relationship to primary disease endpoints, disease change over time, placebo effect, and drug effect on disease. These quantitative relationships can help employ biomarkers (e.g., biochemical, imaging, genomic) in dose finding, the creation of new surrogate markers, planning of effective clinical trials, and making better clinical development and regulatory decisions.