Scientific Issues Raised By Analysis Databases

• Activity Number: 34
• Type: Topic Contributed
• Date/Time: Sunday, August 11, 2002 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section*
• Author(s): Lori Carter-Edwards*+
• Affiliation(s): Rho, Inc.
• Keywords: Analysis Database ; Clinical Trials

Abstract

A Study Analysis Database (SAD) is an analysis database constructed for one clinical trial (CT). A Compound Analysis Database (CAD) combines data from SADs from all CTs of one compound. A SAD or CAD is scientifically engineered and contains source (CRF) data, derived data, metadata, and documentation. Creation of a CAD involves integrating data from multiple studies with varying scientific objectives, often requiring resolution of intricate scientific issues. Data from studies conducted in different regions, e.g., Europe, U.S., may reflect substantial differences in definitions of important variables and data collection methods.

Some believe data integration issues can be solved by software alone. This paper demonstrates that software is only a small part the solution. E.g., a software-only "solution" might combine two variables with the same name from different studies conducted in different cultures that define the variables differently, thus concealing critical differences in meaning and leading to an incorrect analysis and interpretation. This paper shows examples of some scientific issues raised in creating analysis databases, and scientific resolutions of these issues.