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Clinical Trials Cooperative Group Program Guidelines, August 1996I.1. General Description of the Program These guidelines for the National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program have been developed by staff of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), in consultation with staff of the Grants Administration Branch (GAB) and of the Division of Extramural Activities (DEA) and Division of Cancer Prevention and Control (DCPC), NCI as well as with the advice of qualified members of the extramural scientific community. Their purpose is to describe the NCI's goals and expectations for the various applicants and investigators, peer reviewers and National Institutes of Health (NIH) staff who are involved with this Program. They are intended to encourage a research philosophy and discipline that will produce consistently excellent clinical trials, while at the same time permitting each Group to develop structures and procedures that best meet its needs. I.1. GENERAL DESCRIPTION OF THE
PROGRAM The NCI's Clinical Trials Cooperative Groups (henceforth termed the Groups) consist of researchers at institutions affiliated with the Groups, who jointly develop and conduct cancer treatment clinical trials in multi-institutional settings. Administered by CTEP staff, they are a major component of the extramural research effort of the DCTD, NCI. Each Group is supported to continually generate new trials compatible with its particular areas of interest and expertise, as well as with national priorities for cancer treatment research. Unlike most other major NIH cooperative clinical trials efforts, Group structure and funding are not usually linked to any specific clinical trial(s). This mechanism thus has the potential for considerable flexibility in resource allocation, and for the rapid testing of promising new cancer therapies in large patient populations, since the apparatus for conducting such trials is constantly in place. The Groups have been instrumental in the development of new standards of cancer patient management, and in the development of sophisticated clinical investigation techniques. The Clinical Trials Cooperative Group Program was conceived in 1955 when Dr. Sidney Farber, Mary Lasker, and others approached Congress with a proposal that it increase support for studies of chemotherapy for cancer. Congress responded by appropriating $5 million to the National Cancer Institute to establish the Chemotherapy National Service Center. By 1958, seventeen Groups were organized which operated under research grants from NCI; their main thrust was the testing of new anticancer agents from the NCI drug development program. Over the intervening years the Program has evolved into one which places major emphasis on definitive studies of combined modality approaches to the treatment of cancer. In 1980-81, the mechanism of support for the Clinical Trials Cooperative Group Program was converted from the grant to the cooperative agreement. The purpose of this change was to define the involvement of NCI program staff in the coordination of Group activities. Approximately 20,000 new patients are accrued onto Group treatment studies each year, 12,000 are evaluated annually on ancillary laboratory correlative studies, and many times the combined number are in follow-up. Thousands of individual investigators participate in Cooperative Group protocols. The Cooperative Groups are heterogeneous in their research objectives and their structures. These Groups presently are four major types: (1) Groups that are specifically disease oriented (e.g., gynecologic oncology); (2) Groups that are designed to deal primarily with high technology, single modality studies (e.g., radiation therapy), (3) Groups in which the investigators have a particular expertise (e.g., pediatricians); and (4) multimodal national Groups. The common thread, however, is the development and conduct of large-scale trials in a multi-institutional setting. II. PURPOSE OF THE CLINICAL TRIALS
COOPERATIVE GROUP PROGRAM The essential feature of the Clinical Trials Cooperative Group Program is the support of organizations which continually generate and conduct new clinical trials consistent with national priorities for cancer treatment research. Emphasis is placed on definitive, randomized Phase III studies and the developmental efforts preliminary to them. While a wide variety of investigational efforts are therefore appropriate, this Program specifically does not overlap with or replace funding mechanisms for more narrowly focused, Research Project Grant activities (e.g., RO1, PO1 grants and U01, U19 cooperative agreements). III. GOALS OF COOPERATIVE GROUP
RESEARCH III.1. Improve Therapy Therapeutic research aimed at improving the survival and quality of life for persons with cancer is of highest priority to CTEP. The database of patient information accumulated in the course of treatment research, and the possibilities for large-scale collection of biologic samples with subsequent correlation of specific features with patient outcome, provide the Groups with unique opportunities to address scientific questions about molecular genetics, epidemiology, pathology and other cancer-related topics. Such ancillary investigations can add considerable strength to a Group's total scientific program, and are encouraged. While certain studies may be eligible for inclusion in a Group application for financial support, particularly when the laboratory efforts are integral to the clinical trials proposed, a variety of other funding mechanisms - including investigator-initiated grants (R01s, P01s) and cooperative agreements for discrete projects (U01s, U19s) - may also be appropriate. Groups supported by NCI's DCTD may serve as research bases for treatment and cancer control research performed by Community Clinical Oncology Program (CCOP) cooperative agreement awardees which are supported by the NCI's Division of Cancer Prevention and Control (DCPC). While this activity, when present, should be an integrated component of the Group's total research program, peer-review of the CCOP research program including cancer control research for the purposes of NCI financial support will be advisory to the DCPC, and generally will be conducted separately from peer review advisory to the DCTD (see Section VIII, Peer Review). III.4. CLINICAL TRIALS METHODOLOGY The Groups provide a unique framework for research in clinical trials methodology. While CTEP encourages development of and experimentation with new study designs within the Group framework, purely statistical research is appropriately funded through other mechanisms. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS It is the policy of the NIH that women and members of minority
groups and their subpopulations must be included in all NIH
supported biomedical and behavioral research projects involving
human subjects, unless a clear and compelling rationale and
justification is provided that explains why inclusion is
inappropriate with respect to the health of the subjects or the
purpose of the research. This policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 10343)
and supersedes and strengthens the previous policies (Concerning
the Inclusion of Women in Study Populations, and Concerning the
Inclusion of Minorities in Study Populations) which had been in
effect since 1990. The 1993 policy contains some provisions that
are substantially different from the 1990 policies. All investigators proposing research involving human subjects
should read the "NIH Guidelines on the Inclusion of Women
and Minorities as Subjects in Clinical Research," which was
reprinted in the Federal Register of March 20, 1994 (59 FR
1450814513) to correct typesetting errors in the earlier
publication, and reprinted in the NIH GUIDE FOR GRANTS AND
CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from NCI program staff. Program staff may also provide additional relevant information concerning the policy. |
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