Poster presented at the NIH Workshop on Enrollment and Retention of Participants in NIH-Funded Clinical Trials, Bethesda, MD, July 25, 2014
Gaurav Sharma, PhD, Paul C. VanVeldhuisen, PhD, Colleen Allen, MPH (all from the CTN Data & Statistics Center, EMMES Corporation).
The National Drug Abuse Treatment Clinical Trials Network (CTN), established by the National Institute on Drug Abuse (NIDA), conducts research to provide a broad and powerful infrastructure for rapid, multi-site testing of promising science-based therapies and the subsequent delivery of these treatments to patients in community-based treatment. A comprehensive set of reports has been developed to use as a management tool to effectively monitor the progress of ongoing clinical trials. These reports track the progress of each protocol within the CTN from the date of first enrollment/randomization to final closeout and publication of main results. The content includes areas from all aspects of the clinical trials: source of referral, recruitment rates, CONSORT flow diagram, participant's disposition, tracking and attendance of study participants and post-trial communication. These reports provide both a big-picture view of the NIDA CTN protocols and a very detailed view to meet the needs of the varied audience which include: 1) the sponsor and study leadership to assess the overall progress of multiple on-going protocols; 2) the protocol lead teams to monitor their respective protocols in order to identify areas of concern on an individual site levels; and 3) the investigators and staff at each participating community treatment program (CTP) within a protocol to monitor their individual site's performance against other sites.
In this poster, these strategies for tracking and monitoring clinical trials participation and post-trial communication are presented in the context of a CTN clinical trial. (Poster, PDF, English, 2015)
Keywords: CTN protocol development | Data management | Research design | NIH Workshop on Enrollment and Retention of Participants in NIH-Funded Clinical Trials, 2014
Document No: 1131.
Submitted by Janet Van Dyke, NIDA DSC, EMMES Corporation, 3/4/2015.