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NCI’s Clinical Trials Reporting Program (CTRP)

NCI’s Clinical Trials Reporting Program (CTRP). Gisele A. Sarosy , M.D. Coordinating Center for Clinical Trials (CCCT) National Cancer Institute June 10, 2013. NCI’s CTRP. Rationale Implementation Data Reporting Current Status.

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NCI’s Clinical Trials Reporting Program (CTRP)

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  1. NCI’s Clinical Trials Reporting Program (CTRP) Gisele A. Sarosy, M.D. Coordinating Center for Clinical Trials (CCCT) National Cancer Institute June 10, 2013

  2. NCI’s CTRP • Rationale • Implementation • Data Reporting • Current Status

  3. CTRP Background: 2005 CTWG and 2010 Institute of Medicine Reports • 2005 Clinical Trials Working Group (CTWG) and 2010 Institute of Medicine reports: • NCI had no electronic database that captured all NCI supported trials and their accrual • R01s, R21s, P01s, SPOREs grants and institutionally-supported trials using NCI-funded Cancer Center infrastructure resources were particularly difficult to identify • Available databases did not allow NCI and the broader cancer community to: • Manage the portfolio accountably by monitoring accrual, identifying gaps and duplicative studies • Effectively prioritize clinical trials

  4. CTRP Development Timeline • 2008: Requirements defined and early development • 2009: Initial registration by early adopters, interventional trials only. Clinical Trials Reporting Office (CTRO) established to curate trial registrations, abstract and index protocol information • 2010: Reviewed and revised reporting objectives with cancer community • 2011: NCI-designated Cancer Centers are registering all trials open to accrual on or after January 2009 • 2012: • Patient accrual reporting begins • Trial registration, amendments and updates ongoing

  5. CTRP – Data Reporting • Registration and accrual data already reported to NCI is transferred from the receiving office to CTRP. • CTRP staff register NCI-sponsored trials in Clinicaltrials.gov with XML from the CTRP record. Other sponsors are given access to the XML file from CTRP. • CTRP facilitates results reporting for NCI sponsored trials in ClinicalTrials.gov. • A report in development will provide a list of submitted clinical trials and their associated accrual to NCI- designated Cancer Centers for inclusion in their yearly reports.

  6. Current Status • Registration of all NCI supported trials from NCI-designated Cancer Centers is almost complete. • Accrual reporting is underway. • Methods to automate data transmission are in development. • The system is designed to minimize the burden of data reporting. • Once fully implemented, data on all NCI supported trials and associated accrual will help fulfill the goals outlined by CTWG and Institute of Medicine reports.

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