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National Cancer Institute Sponsorship of Cancer Clinical Trials
In order for a cancer clinical trial to be considered National Cancer Institute-sponsored, it must fall under one of the following four non-mutually exclusive categories:
- NCI Protocol Review Committee-approved study
- NCI Cooperative Group / CCOP Research Base study
- NCI Cancer Center study with NCI-approved protocol review
- NCI Grant study
The National Cancer Institute (NCI) coordinates a national research program of cancer prevention, diagnosis and treatment. As part of this effort, the NCI supports a clinical trials network that includes Cooperative Groups, new drug development cooperative agreement holders, and other investigators at cancer centers, university and community hospitals, and individual practices. Thousands of investigators and hundreds of institutions participate in this network.
Within the NCI, both the Division of Cancer Treatment, and Diagnosis (DCTD) and the Division of Cancer Prevention (DCP) plan, direct and coordinate programs of extramural clinical cancer research. The staff of these NCI divisions formally review clinical trials involving investigational agents in which DCTD or DCP holds the Investigational New Drug (IND) as well as many other clinical trials involving cancer treatment, prevention and diagnosis. All clinical trials that have been reviewed and approved by the Protocol Review Committees of either of these NCI divisions, are considered NCI-sponsored.
The NCI Clinical Trials Cooperative Groups are NCI-funded consortia of academic institutions, cancer centers, Community Clinical Oncology Programs (CCOP), Minority Based CCOPs, and community physicians that work through cooperative agreements to identify important questions in cancer research and to design and conduct carefully controlled clinical trials. There are 11 major Cooperative Groups that involve more than 16,000 individual investigators at more than 2,200 institutions nationwide. All NCI Cooperative Group clinical trials are considered NCI-sponsored except those that are funded exclusively by the pharmaceutical industry.
The NCI Cancer Centers Program comprises more than 50 NCI-designated cancer centers engaged in multidisciplinary research efforts to reduce cancer incidence, morbidity, and mortality. In order for a Cancer Center clinical trial to be considered NCI sponsored, it must have been reviewed and approved at an NCI-designated Cancer Center with an NCI-approved Protocol Review and Monitoring System (PRMS).
The NCI supports clinical investigators through a variety of grant mechanisms.The NCI clinical grants supported through these mechanisms are all peer reviewed and meet both FDA and OPRR (Office of Protection from Research Risks) requirements. Clinical trials conducted under these grants are considered NCI- sponsored.
10/10/07
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