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Tracking and Monitoring Trial Progress in NIDA CTN Studies.

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.

AUTHORS SEARCH LINK
Allen, Colleen mail
Sharma, Gaurav mail
VanVeldhuisen, Paul C. mail

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 3/2015 -- http://ctndisseminationlibrary.org/display/1131.htm
info@ctndisseminationlibrary.org
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