Clinical Trials Reporting Program

Overview of CTRP

NCI's Clinical Trials Reporting Program maintains a comprehensive database of information on all NCI-supported interventional clinical trials open to accrual as of January 1, 2009. This database, also referred to as CTRP, helps identify gaps and duplicate studies in clinical research, facilitates clinical trial prioritization, and standardizes trial data capture and sharing.

Key benefits of CTRP include:

• Standardized abstraction of protocol information
• Consistent terminology and coding to optimize search and retrieval of cancer trials information
• Biomarker and patient-level accrual data
• Standardized person and organization data elements

For additional CTRP topics, see:

• CTRP System Access and Training
• Trial Registration, Amendments, and Updates
• Accrual Reporting

Definition of NCI-supported Trials

NCI-supported means all interventional clinical trials, whether extramural or intramural, sponsored or otherwise financially supported by NCI. Such trials include:

• All National trials, e.g. NCTN, ETCTN, NCORP trials
• Any trial conducted at an NCI-designated Cancer Center (with P30 center core grant), including all industrial trials
• Trials conducted under any type of contract, grant, or cooperative agreement supported by the NCI (e.g., R01, N01, SPOREs, P01, U01, U10)

Use of Clinical Trial Information

All publicly available CTRP clinical trial information is available through the clinical trials search feature on Cancer.gov. This does not include regulatory information such as IRB approval details, IND/IDE information, NCI-specific Data Table 4 information, or biomarker data. In addition, no accrual information, patient-level or summary, is made public.

In addition, data from CTRP is also available via an application programming interface (API). Documentation for developers can be found on https://clinicaltrialsapi.cancer.gov. Developers can also check out the Clinical Trials API code and example widget from our Github.

NCI-designated Cancer Centers and other grantees can log in to CTRP and perform searches on all trials they have submitted as well as those where they are listed as a participating site. If a center requires a more detailed report on their trials, they may submit a request via the CTRO (ncictro@mail.nih.gov) and a CTRP analyst will work with them to generate a custom report.

Origin of CTRP

Enlarge

CTRP was established in response to a recommendation made by the NCI Clinical Trials Working Group (CTWG) to the National Cancer Advisory Board (NCAB), and reiterated by the Institute of Medicine’s (IOM) report titled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.

Key conclusions of 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, SPORE 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