Project #52: Process Improvement in Interventional Research Through Utilization of a Clinical Trials Management System (CTMS)

Introduction: Until recently, the management of clinical trials at Henry Ford Health has been largely decentralized, creating a disparity in trial administration and oversight from study to study. Individual departments and study teams were responsible for determining how their interventional research would be organized and conducted. This led to a vast variation in the way that Henry Ford researchers tracked and maintained research portfolios, study records, subject participation, as well as budgeting and invoicing practices. This autonomy also created further difficulties in compiling pragmatic research metrics, and a challenge in recognizing the full extent of the interventional research being conducted at a system level (1). In an effort to standardize and unify interventional research across the system, Henry Ford Health - Research Administration began the process of implementing a Clinical Trials Management System (CTMS) across all research units that conduct interventional clinical trials. A CTMS provides the opportunity for a standardized structure for tracking study activity, maintaining regulatory documents, invoicing for research efforts, and ultimately offers a platform for recognizing clinical trial activity at both the department and system level (2). While the implementation of the CTMS is still ongoing, and an ultimate understanding of this initiative’s success is yet to be seen; an early indicator of the system’s potential effectiveness is the real and perceived benefit experienced by newly trained end-users of the platform (3). As a very early measure of the gains experienced through this system, a survey was conducted with the currently active CTMS end-users, asking about any real or perceived benefit that the system may offer in helping conduct interventional research. Methods: A voluntary survey was sent to all end-users of the Oncore CTMS at Henry Ford Health via a web-based survey platform. The population of end-users surveyed consisted of research staff involved in interventional clinical trial research and was made up of Principal Investigators, Sub Investigators, Research Coordinator, Research Nurses Regulatory Coordinators and Financial Coordinators. The survey asked the end-user to answer 5 yes or no questions about real and perceived benefits of utilizing the Oncore CTMS. The results of the survey were compiled and classified as either a positive or negative metric of perceived usefulness. Results: Thirty-five Oncore CTMS end-users participated in the voluntary survey. All five survey questions yielded results that suggest that system end-users believed the implementation of the Oncore CTMS provided a perceived benefit. The survey results showed that 66% of respondents felt that oncore improved communication within their team, 86% felt they benefited from using Oncore CTMS, 83% believed that Oncore CTMS positively affected their workflow or team process; 71% have felt that Oncore CTMS improved the organization of protocol related items; and 91% believed that Oncore CTMS has the potential to improve their departments workflow in the future. Conclusions: While perceived benefit is just one metric measured in the constructs utilized to determine the success of information systems like a CTMS (3), and on its own does not prove the value of a system, it does offer the opportunity to gain an early glimpse of systems potential usefulness. It is understood that no relevant conclusions can be drawn about the successes of implementing a CTMS based upon the perceived benefit alone, and that additional research will need to be conducted after the system implementation is completed.