Diversity data in oncology electronic data capture and database design: A global overview, gap analysis and recommendations for industry from the imCORE network, a worldwide research network designed to connect members in an open environment of shared information, expertise, and decisions.

Abstract

101 Background: The importance of enrolling diverse and inclusive patient populations in clinical trials has never been more critical however the implementation of measures to ensure inclusive clinical trials remains inconsistent and challenging industry wide. One key mechanism for tracking diversity in clinical trials is the database design of patient demographic classifications. Methods: In this paper we utilize the global reach of the imCORE network to explore the current trends in clinical trial database design for demographic data. We collect and review data on the design of electronic database systems from a diversity of sources including Roche Genentech clinical trial database frameworks and databases at our imCORE sites. We then provide a global electronic database demographic data classification overview and gap analysis. Results: Findings related to electronic database design, demographic data collection process, barriers to capturing diversity and demographic data are presented. Conclusions: Based on our findings we make recommendations from the site and sponsor perspective for an improved future state of electronic demographic diversity data collection in clinical trials with the goal of ultimately leading to meaningful change toward fully inclusive and equitable clinical trials.