Development of a QT database with analytic tools: Preliminary results

Abstract

Background Development of tools for centralized QT data storage and analysis should facilitate the regulatory review process. Methods We initiated projects to (1) centrally locate all QT data available in CDER/FDA using MS Access and (2) create Graphical User Interface tools using Visual Basic allowing reviewers to add, query & analyze data and generate reports. Data from 30 QT studies with diverse data formats and study designs were considered. Results The system allows users to efficiently enter, sort and extract data of various formats, use query criteria to make cross-trial comparisons and generate statistics. Trends observed across the studies are: 60% of designs involve collection of a single ECG at a given time; 80% are placebo-controlled trials; single- or multiple- dose studies and fed or fasted designs are equally common; 50% of studies enroll subjects >65 years; 40% are single-gender studies. Fridericia and Bazett heart rate correction methods are equally common while an Individual Correction is reported in 20% of the trials. Conclusions When fully developed, the project should enable menu-driven data entry and point-and-click data analyses. The project should also streamline, standardize, and assist the FDA review process. Clinical Pharmacology & Therapeutics (2005) 77, P13–P13; doi: 10.1016/j.clpt.2004.11.053