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Clinical Trials Cooperative Group Program

(Original available; currently being reviewed and revised)

Table of Contents

Introduction

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. The scope of this program includes:

  • Approximately 20,000 new patients are accrued onto Group treatment studies each year.
  • 12,000 new patients 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)
  4. Multimodal National Groups

The common thread, however, is the development and conduct of large-scale trials in a multi-institutional setting.

Purpose of the 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).

One of the primary objectives underlying the formation of the Groups is the conduct of large multicenter trials for the investigational agents sponsored by CTEP. This allows the rapid accrual of patients while reducing the possible bias of studies carried out at a single or a few institutions.

Goals of Cooperative Group Research

1. IMPROVE THERAPY

Therapeutic research aimed at improving the survival and quality of life for persons with cancer is of highest priority to CTEP.

2. ADJUNCT STUDIES

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.

3. 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.

CTEP and the Cooperative Group Program

The NCI's Clinical Trials Cooperative Groups (the Cooperative Groups) consist of researchers at institutions affiliated with the Cooperative 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 Cooperative 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, the Cooperative 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
  • the rapid testing of promising new cancer therapies in large patient populations

This is feasible through the Cooperative Groups as they provide the apparatus for conducting such trials where the apparatus is constantly in place.

The Cooperative Groups have been instrumental in the development of new standards of cancer patient management, and in the development of sophisticated clinical investigation techniques. See Clinical Trials Cooperative Group Accomplishments, 1986-2001 (MS Word .doc)

CTEP funds over 150 U10 cooperative agreements encompassing the following Cooperative Groups:

  1. Cancer and Acute Leukemia Group B (CALGB)
  2. Children’s Cancer Study Group (CCSG)
  3. Eastern Cooperative Oncology Group (ECOG)
  4. Gynecologic Oncology Group (GOG)
  5. National Surgical Adjuvant Breast and Bowel Project (NSABP)
  6. North Central Cancer Treatment Group (NCCTG)
  7. Pediatric Oncology Group (POG)
  8. Radiation Therapy Oncology Group (RTOG)
  9. Southwest Oncology Group (SWOG)
  10. Intergroup Rhabdomyosarcoma Study Group (IRSG)
  11. National Wilms’ Tumor Study Group (NWTSG)
  12. American College of  Surgeons Oncology Group (ACOSOG)

The annual funding amount for the Cooperative Groups is approximately $90 million. Clinical trials for investigational anticancer agents are conducted under more than 175 INDs sponsored by DCTD, NCI and are carried out in part by the Clinical Trials Cooperative Groups. This includes investigational agents provided to DCTD, NCI by over 50 Industry Collaborators.

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