The GSK Clinical Study Results Database: Site Utilization Metrics for a Large Public Database

摘要

Background: Establishing additional mechanisms for providing public information on clinical studies being conducted and results from completed clinical trials is a topic of significant public debate. This report provides the experience to date with utilization of the GlaxoSmithKline clinical study results database (GSK CSRD), currently the largest of the single-sponsor, publicly accessible databases with information from 2,635 studies involving 59 products. Methods: Database queries were conducted to evaluate the routes and frequency of database access over a 22-month period following GSK CSRD launch. To evaluate the potential for meaningful clinical data extraction during a site visit, queries were conducted to examine the number of pages accessed and the amount of time spent on the database during an individual visit. Results: The number of user sessions on the database is increasing steadily over time as more products/studies have been added to the GSK CSRD. Over time, the individual number of sessions involving the review of six or more CSRD pages (ie, one study summary) or greater than one minute in duration has increased substantially. Conclusions: Access of the GSK CSRD has increased substantially since launch. Although current data indicate that a distinct majority of sessions are not likely to lead to the extraction of meaningful clinical information, the absolute number of individual sessions where there is likelihood that meaningful data may have been extracted has increased significantly over time. These data serve as a useful benchmark against which to judge the evolution of understanding and processes regarding the optimal use of clinical study results databases.