1 / 6

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.

leane
Download Presentation

NCI’s Clinical Trials Reporting Program (CTRP)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related