DCTD CLINICAL TRIALS COOPERATIVE GROUPS Release Date: January 29, 1999 PA NUMBER: PA-99-058 P.T. National Cancer Institute PURPOSE The National Cancer Institute (NCI) is reannouncing its willingness to accept applications from institutions interested in conducting multi-institutional clinical trials in a Cooperative Group setting. Awards will continue to be made using the cooperative agreement mechanism (U10). Potential applicants are encouraged to contact the Cancer Therapy Evaluation Program staff to discuss and/or clarify any issues or questions regarding this announcement. The "CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES" and the Cooperative Group Terms and Conditions of Award are available from the NCI Program Director upon request (see INQUIRIES). A copy of the Guidelines and the Terms and Conditions of Award are available on the World Wide Web at http://ctep.info.nih.gov/CGroupGuide/GuidelinesContents.htm. This Program Announcement (PA) replaces PAR-95-063, which was published in NIH Guide, Volume 24, Number 19, May 26, 1995. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, DCTD Clinical Trials Cooperative Groups, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238) or at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations (including consortia of institutions), public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument used for this program is a cooperative agreement (U10), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. The "Terms and Conditions of Award," which detail the responsibilities, relationships, and governance of the studies to be funded under these cooperative agreement(s) are available from the program staff listed under INQUIRIES. Participation by NCI through the Associate Director for CTEP and selected designees provides assistance in the nature of information on NCI priorities and ongoing efforts elsewhere within the scientific community, as well as oversight, through the protocol review process and the Clinical Trials Monitoring Branch and Regulatory Affairs Branch, of methodology, feasibility, and adherence to regulatory requirements. Any subsequent updates to the terms and conditions of award will apply to any awards made under this program announcement. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of awards will vary also. RESEARCH OBJECTIVES Background The NCI's Clinical Trials Cooperative Groups (henceforth termed, "the Groups") were conceived in 1955 when Congress appropriated funds to the National Cancer Institute to establish the Chemotherapy National Service Center. By 1958, seventeen Groups were organized that 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 Group Program has evolved into one that places major emphasis on definitive studies of combined modality approaches to the treatment of cancer, and on the developmental efforts preparatory to such trials. Most recently, increasing attention has been give to translational research, correlating biologic insights gained from the laboratory with disease behavior and treatment outcome. 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. There are currently twelve NCI-funded Groups; approximately 20,000 new patients are accrued into their treatment studies each year, and many times that number are in follow-up. Thousands of individual investigators participate in Cooperative Group protocols. Currently, over $100 million is awarded annually by the NCI in support of Group research. The Groups consist of researchers at institutions affiliated with the Groups, who jointly develop and conduct cancer treatment clinical trials in multi-institutional settings. They are a major component of the extramural research effort of the Division of Cancer Treatment and Diagnosis. 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 essential feature of the Clinical Trials Cooperative Group Program is the support of organizations that 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., R01, P01, U01, U19). The Cooperative Groups are heterogeneous in their research objectives and their structures. These Groups presently are of 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., radiotherapy); (3) Groups in which the investigators have a particular expertise (e.g., pediatricians); and (4) multimodality Groups. The common thread, however, is the development and conduct of large-scale trials in a multi-institutional setting. The goals of the Groups are: 1. IMPROVEMENT OF THERAPY: Therapeutic research aimed at improving the survival and quality of life for persons with cancer is of highest priority. 2. ADJUNCT STUDIES: The database of patient information accumulated in the course of treatment research, including the possibilities for large-scale collection of tissue samples with subsequent correlation of biologic features with patient outcome, provide the Groups with unique opportunities to address scientific questions about genetics, etiology, epidemiology, pathology and other cancer-related topics. Such ancillary investigations can add considerable strength to a Group's total scientific program, and are strongly 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, R03s, P01s) and cooperative agreements for discrete projects (U01s, U19s) - may also be appropriate. 3. CANCER CONTROL: Groups supported by NCI's Division of Cancer Treatment and Diagnosis may serve as research bases for treatment and cancer control research performed by Community Clinical Oncology Program (CCOP) cooperative agreement awardees supported by the NCI's Division of Cancer Prevention. 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 Division of Cancer Prevention, and generally will be conducted separately from peer review advisory to the Division of Cancer Treatment and Diagnosis. 4. CLINICAL TRIALS METHODOLOGY: The Groups provide a unique framework for research in clinical trials methodology. While CTEP welcomes development of and experimentation with new study designs within the Group framework, purely statistical research is appropriately funded through other mechanisms. SPECIAL REQUIREMENTS Each Cooperative Group should consist of three major operational components that collaborate to conduct the research agenda of the Group: the headquarters (including the Group Chair's office), the central statistical/data management office, and the participating investigators and institutions. Each component should have general responsibilities in meeting the goals and objective of the Cooperative Group or in completing tasks necessary to accomplish those goals. Each Group must be governed by a constitution and bylaws, which describe membership criteria, procedures for selecting group leadership and other details of governance. Each Group must be led by a chairperson who is ultimately responsible for the content and conduct of the Group's research program. Beyond these requirements, the structure and management of the individual Group is the responsibility of the Group itself to determine. The headquarters is the direct responsibility of the Group chairperson. It should provide executive leadership and day-to-day administrative management of the Group. Through this office the chairperson implements the Group's scientific and organizational policies. A Group's statistical and data management staff must be integral collaborators in all stages of study development, conduct, analysis, and reporting. It is anticipated that member institutions will be, for the most part, academic centers and their affiliated institutions, or large community practices supported through the CCOP programs. In addition to patient accrual, member institutions should provide scientific and administrative contributions to the Group. Each Group must establish its own specific criteria for membership and a formal process for application for Group membership. Terms and Conditions of Award Awards will include the "Terms and Conditions of Award," which detail the responsibilities, relationships, and governance of the studies to be funded under these cooperative agreement(s). These terms and conditions are available from the program staff listed under INQUIRIES and can be found at URL: http://ctep.info.nih.gov/CGroupGuide/Guidelines10.htm. 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 inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) 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 have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at the following URL address: http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1 and Type 2) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html. Applicants for National Cancer Institute (NCI) funding who propose clinical research for adults with cancer may use language similar to the following for the "Participation of Children" section of their application: "This protocol/project does not include children because the number of children with cancer is limited and because the majority are already accessed by a nationwide pediatric cancer research network. This exemption is based on Exclusion 4b of the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects." LETTER OF INTENT It is strongly recommended that a letter of intent, which includes a descriptive title of the proposed research, the name, address, and telephone of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this program announcement be submitted at least six months in advance of the application submission deadline. A member institution that intends to apply or reapply out of cycle with the parent Group should submit a letter of intent as early as possible prior to the submission of the application. A letter of intent is not binding and is not a precondition for submission, review or award. APPLICATION PROCEDURES Potential applicants (proposed Chairperson) are strongly encouraged to contact NCI staff (See INQUIRIES) prior to the preparation and submission of an application to discuss NCI's programmatic interest in supporting the proposed Cooperative Group. Copies of the Cooperative Group Guidelines and additional information that will be helpful in preparing applications should be requested at that time. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted on the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435- 0714, email: grantsinfo@nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The code U10 must be entered in section 2b. For those applicants with internet access, the 398 kit may be found at http://www.nih.gov/grants/forms.htm Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://www.nih.gov/grants/guide/notice-files/not98-030.html. The receipt dates and review schedule are as follows: Application Receipt Dates: Feb 1 Jun 1 Oct 1 Site Visit (if applicable): May/Jun Sep/Oct Jan/Feb Review Committee Meeting: Jun/Jul Oct/Nov Feb/Mar NCAB Meetings: Sep/Oct Jan/Feb May Earliest Possible Funding: Dec 1 Apr 1 Aug 1 Each applicant for a U10 cooperative agreement shall submit a signed, typewritten original of the application, including the checklist and three signed photo copies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all copies of appendix material must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Because of the interrelatedness of various components, all of the individual applications from a particular Cooperative Group must be submitted and reviewed at the same time; similarly, funding recommendations for all of the components are usually of the same duration and time frame. Exceptions include competing supplement applications and applications from individual members submitted out of sequence with the remainder of the Group. Even in these cases, however, adjustments are made in the award such that funding periods coincide with those of the remainder of the Group. REVIEW CONSIDERATIONS AND REVIEW CRITERIA Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Applications will be reviewed for scientific and technical merit by the Clinical Groups Subcommittee, Subcommittee H of the NCI Initial Review Group, Division of Extramural Activities, in accordance with the standard NIH peer review procedures and in accordance with the "CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES" available from the NCI Program Director upon request (see INQUIRIES) and available at http://ctep.info.nih.gov/CGroupGuide/GuidelinesContents.htm. Because of their interrelatedness, all applications from all components of a particular Cooperative Group are reviewed simultaneously (except in the case of member applications submitted out-of sequence with the parent Group). The full IRG review is usually preceded by a site visit to the Group's statistical and data management facilities. The site visit team generally consists of a subset of Subcommittee H members plus ad hoc reviewers as indicated by the proposed work scope. Following scientific-technical review, the applications will receive a second- level review by the National Cancer Advisory Board. Review Criteria The three components of each proposed Cooperative Group will be reviewed in accordance with the Review Criteria found in the "CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES" and available at http://ctep.info.nih.gov/CGroupGuide/Guidelines8.htm. AWARD CRITERIA Applications will compete for available funds with all other approved Cooperative Group U10 applications assigned to the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, NCI. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Richard S. Ungerleider, M.D. Division of Cancer Treatment and Diagnosis National Cancer Institute Executive Plaza North, Suite 741 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (if using express mail) Telephone: (301) 496-2522 FAX: (301) 402-0557 Email: ru4m@nih.gov Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Management Branch National Cancer Institute Executive Plaza South, Room 242 6120 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (if using express mail) Telephone: (301) 496-7800, ext. 282 FAX: (301) 496-8601 Email: cw104j@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Blvd., MSC-7399 Rockville, MD 20850 (express courier) Bethesda MD 20892-7399 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and part 92. This program is not subject to the inter governmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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