Excerpt from National Cancer Institute Annual Report, Vol. 2: October 1, 1989, Through September 30, 1990
The Cancer Therapy Evaluation Program (ctep) is responsible for the administration and coordination of the majority of the extramural clinical trials supported by oct. These programs include the activities of the Clinical Cooperative Groups, the Phase I and Phase 11 new agent development contractors, and the holders of investigator-initiated grants (roi and P01) relating to cancer treatment. Certain programs in developmental radiotherapy, such as high let radiation, are administered in the Radiation Research Program. The Phase I development of biologic response modifiers is handled by the Biological Research Modifiers Program.
The Investigational Drug Branch (108) is responsible for sponsoring trials of new investigational drugs and of evaluating them for efficacy and toxicity. It does this by: I) Coordinating and monitoring the trials of new agents developed by the oct; 2) Planning with members of the Clinical Investigations Branch (see below overall strategies for new agent studies in specific tumor types; 3) Regulating the distribution of investigational new drugs for which oct is the sponsor; 4) Maintain close contact and ongoing dialogue with the pharmaceutical industry in an attempt to ensure that new agent development proceeds in a coordinated way.
The Clinical Investigations Branch (cib) is responsible for development and implementation of disease-oriented treatment strategies across the spectrum of human malignancies. In doing so, it provides management and oversight of the clinical cooperative group program. It manages the oncology portfolios of R01 and P01 grants.
The Regulatory Affairs Branch (rab) monitors the conduct of clinical trials performed in the nci-supported clinical trials network. It also assures that clinical investigators using experimental agents are in compliance with federal regulations regarding the use of such agents. At the start of the clinical testing of each investigational gent, rab obtains Investigational New Drug (nda) exemption authorization from the Food and Drug Administration (fda) and maintains close communication with fda in all matters relating to experimental drug studies.
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