CTRP Program - FAQs
- What is the purpose of the Clinical Trials Reporting Program (CTRP)?
- How will CTRP be connected to other databases within NCI and NIH?
- Will CTRP support the Cancer Centers Summary 4 Report?
- Will CTRP register my trials with Clinical Trials.gov for me?
- If I register a trial with CTRP, will CTRP send the trial to PDQ?
What is the purpose of the Clinical Trials Reporting Program (CTRP)?
The CTRP fulfills a major initiative of the Clinical Trials Working Group (CTWG) report: to provide a shared foundation of information by establishing a comprehensive database containing regularly updated information on all NCI-supported clinical trials. The April 2010 Institute of Medicine report, National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program reiterated the need for a comprehensive database of cancer clinical trials. A comprehensive database of the entire NCI portfolio will help to identify gaps in clinical research and duplicative studies, as well as facilitate effective clinical trial prioritization.
How will CTRP be connected to other databases within NCI and NIH?
The CTRP informatics system is based on NCI Enterprise Services, a set of common, shared information services. CTRP will receive data from databases maintained within the Cancer Therapy Evaluation Program (CTEP), the Division of Cancer Prevention (DCP) and the Center for Cancer Research (CCR), using NCI Enterprise Services where possible and file transfer where not. It is expected that over time synchronization between all systems will be seamlessly migrated to NCI Enterprise Services.
Will CTRP support the Cancer Centers Summary 4 Report?
CTRP is working with the NCI Cancer Centers Program to address the reporting requirements for Summary 4. It is anticipated that this capability for CTRP to generate information in support of a Summary 4 report for interventional trials will be available in 2012 once CTRP is fully configured to allow submission of patient accrual data.
Will CTRP register my trials with ClinicalTrials.gov for me?
No. The NIH has advised NCI that it can no longer submit data to ClinicalTrials.gov on behalf of NCI awardees either through CTRP, PDQ or any other system. NCI awardees and contractors that are Responsible Parties as defined by the Food and Drug Administration Amendments Act of 2007, P.L. 110-85 (FDAAA) are responsible for submitting data to ClinicalTrials.gov in compliance with FDAAA. The NCI is not in control of these requirements. As a result, CTRP was enhanced in 2009 to abstract information for ClinicalTrials.gov registration and to return a XML file to institutions for independent validation and then submission.
If I register a trial with CTRP, will CTRP send the trial to PDQ?
Yes. CTRP is intended to act as a "one stop shop" for reporting. Data entered into CTRP will be received by PDQ.
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