This Program Announcement expires on October 2, 2003, unless reissued CLINICAL CANCER THERAPY RESEARCH Release Date: October 2, 2001 PA NUMBER: PA-02-002 (see replacement PA-04-046) National Cancer Institute THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. This Program Announcement (PA) replaces PA-99-046, which was published in the NIH Guide on January 22, 1999. PURPOSE The National Cancer Institute (NCI) seeks grant applications to conduct clinical therapeutic studies/trials of neoplastic diseases in humans. Clinical research, by definition, is research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. This Program Announcement (PA) encompasses a full range of therapeutic studies and clinical trials employing drugs, biologics, radiation, and surgery. The intent of the PA is to encourage clinical researchers to translate insights in cancer biology and the development of new agents into innovative cancer therapeutic studies. RESEARCH OBJECTIVES Background Highly productive research efforts into understanding the basic biology of the cancer cell have resulted in discoveries concerning the role of growth factors, genes that promote and suppress neoplasia, mechanisms of treatment sensitivity and resistance, and the biology of the immune systems. These discoveries have provided the basis for the development of novel and improved cancer treatments especially related to inhibitors of specific molecular targets/pathways. The rate of progress in the treatment of cancer depends upon the translation of these basic and preclinical discoveries into clinical cancer therapies. The NCI supports an extensive network of clinical and laboratory research studies related to cancer therapy through contracts, grants and cooperative agreements. At present, the traditional research grant mechanism (R01) is underutilized by clinical investigators for the support of clinical research. NCI is committed to supporting clinical trials research and encourages clinical investigators to submit clinical therapeutic studies to move advances in basic biology and drug development into the clinical setting. OBJECTIVES AND SCOPE The overall aims of this initiative are two-fold: (1) to stimulate development of innovative therapeutic clinical trials with or without laboratory correlations (2) to support innovative correlative laboratory studies linked to therapeutic clinical trials to foster the development of interactions between basic science laboratories and clinicians performing the clinical trials. Investigators may address either aim in their applications. Clinical studies/trials must involve human subjects and be therapeutic in design. The clinical studies must be based on a strong rationale and preclinical or clinical data which supports the underlying hypotheses. The applications may include single or multi-institutional research studies with appropriate biological correlates linked to these studies. New clinical therapeutic trials may employ drugs, biologics, radiation, or surgery used as single agents/modalities or in combination. Biological correlative studies that have clinical relevance to therapeutic studies and are aimed at improving cancer treatment are also appropriate. Support for the conduct of the clinical trial and/or patient monitoring and correlative laboratory studies that have clinical relevance to the therapeutic clinical trial may be requested. A rigorous description of the rationale and methodology for the laboratory components of the study, as well as a description of how the results will be analyzed in conjunction with the results of the clinical trial, should be provided. Laboratory studies using patient specimens from the clinical trial may include patient monitoring studies (i.e., pharmacokinetics, immune response, etc.) or clinical correlative studies that may guide clinical development of the new agent or approach or identify patient subsets for specific therapies. Laboratory studies of the underlying mechanisms of intervention, the mechanisms of disease pathogenesis, or surrogate markers of disease activity and therapeutic effect are encouraged. Statistical design issues should be addressed in the research plan for both the clinical protocol and the laboratory analyses. The proposed research plan should convince reviewers that the planned studies are well conceived, that the methodology is solidly grounded and practical for use in a clinical trails setting, and that the analysis plan is sensible and likely to be informative. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. Investigators interested in submitting R21 grant applications in this research area are referred to PA-00-047, Quick-Trials for Novel Cancer Therapies (http://grants.nih.gov/grants/guide/pa-files/PA-00-047.html) and PA-01-010, Exploratory Studies in Cancer Detection, Prognosis and Prediction (http://grants.nih.gov/grants/guide/pa-files/PA-01-010.html) and PA-01-015, Correlative Studies using Specimens from Multi-Institutional Prevention and Treatment Trials (http://grants.nih.gov/grants/guide/pa-files/PA-01-015.html). PA-01-015 also solicits for R01 grants in addition to R21 grants. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or 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. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Roy Wu or Dr. Heng Xie Division of Cancer Treatment and Diagnosis National Cancer Institute Executive Plaza North, Room 7009 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: rw51j@nih.gov Email: xieh@ctep.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Kelli Oster Grants Management Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8627 FAX: (301) 496-8601 Email: osterk@mail.nih.gov APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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 National Cancer Institute (NCI) program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the application must obtain agreement from the NCI staff that NCI 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. Submit a signed, typewritten original of the application, including the checklist, and five signed, exact, single-sided photocopies, 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) REVIEW CONSIDERATIONS Applications will be assigned based on established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyzes adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigator: is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: o the appropriateness of proposed project budget and duration, o the adequacy of plans to include both genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, o the provisions for the protection of human subjects, o the safety of the research environment, o the adequacy of the proposed plan to share data. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. 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 sub-populations 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 indicating that 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 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups, if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 reasons not to include them. This policy applies to all initial (Type 1) 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://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. DATA AND SAFETY MONITORING PLAN All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available to http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is now available online at http://cme.nci.nih.gov/. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This PA, Clinical Cancer Therapy Research, is related to priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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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