CLINICAL TRIAL PLANNING GRANT Release Date: October 5, 2000 RFA: AR-00-010 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: February 8, 2001 Application Receipt Date: March 19, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The goal of the NIAMS Clinical Trial Planning Grant is to provide support for planning activities critical for the successful implementation of clinical trials in areas of interest to the NIAMS. In addition, the Planning Grant is intended to (a) allow for early peer review of the rationale and design for complex or large-scale clinical trials and studies in those areas that are in the NIAMS mission, (b) provide support for the development of a detailed clinical trial research plan, including a manual of operations and procedures, as a means of decreasing the long start-up time often needed for initiating large trials after award, and (c) provide support to refine critical components of a clinical trial protocol, such as outcome measures, recruitment strategies, inclusion and exclusion criteria, etc. Applicants should be aware that the award of a Planning Grant does not guarantee NIAMS acceptance of the full-scale clinical trial for peer review, nor subsequent funding of the trial following peer review. However, it is expected that the applicant will develop a full-scale clinical trial for submission to a public or private agency if the Clinical Trial Planning Grant funded 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 Request for Applications (RFA), Clinical Trial Planning Grant, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, 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 This RFA will use the R21 award mechanism. Applicants can request direct costs in $25,000 modules, up to a total direct cost request of $75,000. This is a one-year award. For the purposes of this solicitation the research plan for the application must be limited to 15 pages and appendix material will not be accepted. FUNDS AVAILABLE It is estimated that $500,000 total costs will be available for support of this initiative. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and Administrative costs will be awarded based on the negotiated rates. Awards are contingent on the availability of funds and the receipt of highly meritorious applications. RESEARCH OBJECTIVES Background Complex or large-scale clinical trials and studies require extensive planning. A clinical trial requires detailed information on the study design, protocols and procedures, analytical techniques, identification of facilities, and organization of an effective group of investigators with an effective administrative plan. The clinical trial research plan is best presented in a well-documented Manual of Operations and Procedures (MOP) that is submitted as part of the application/proposal for the clinical trial. However, preparation of a MOP is a time-consuming and expensive activity. The NIAMS Clinical Trial Planning Grant can help support this activity as well as other administrative aspects of planning a clinical trial. For some diseases of interest to the NIAMS the design and implementation of successful clinical trials has been hampered by the lack of refined outcome measures, difficulties with recruitment of patients with rare diseases, and lack of information about standardization of procedures among participating clinics. The NIAMS Clinical Trial Planning Grant also provides an opportunity to support these activities. Examples of Research Objectives for the Planning Period The actual activities performed during the planning period will depend upon the nature of the trial, and the degree to which the investigators have already developed their trial. The planning activities should be such that they would enable imminent commencement of the actual clinical trial. A few examples are: o Testing recruitment strategies o Developing subject retention strategies o Conducting meetings to address issues such as trial design, methodologies, etc. o Preparing a Manual of Operations and Procedures (MOP), a specific safety plan, etc. Other Detailed information regarding the rationale of the clinical trial, based on adequate preclinical science and preliminary clinical research, must be developed prior to submission and included in the Clinical Trial Planning Grant application. The purpose of the planning grant is not to support activities of a pilot, or Phase I trial or to conduct studies to support the rationale for the clinical trial. Examples of expected products of the planning grant are a complete Manual of Operations and Procedures, validated outcome measures, or proven feasibility of a new recruitment plan. Any disease area that is within the NIAMS mission is appropriate for consideration under this RFA. SPECIAL REQUIREMENTS The Research Plan should be presented in two parts as described below. Applicants are encouraged to address issues listed in "Review Criteria" and "Specific Review Criteria" in this RFA. PART 1 - FUTURE CLINICAL TRIAL (Approximately 2-5 pages) This part may or may not be written using the standard headings of PHS form 398 (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods, and Human Subjects) but should clearly describe the following items: o Specific Aims, including a clear statement of any hypotheses that the clinical trial would address. o Background/Rationale - Provide rationale for the trial. The rationale must be supported by existing data/information. The planning grant is not to be used to conduct studies in order to rationalize the clinical trial. o Significance - Give information documenting significance and the need to perform the clinical trial. Describe the potential impact of the clinical trial on health care: What is the need for new therapy? What are the potential advantages and disadvantages of competitive therapies? o Research Design and Methods - No details are required, but enough information should be provided to evaluate how the trial would be conducted. Pertinent information must be included on: (a) Intervention(s) to be used, reasons for the selection of intervention(s), and mode(s) of delivery, (b) study design, treatment group(s), trial size, and inclusion/exclusion criteria (if not developed yet, please state so, and you may include it as a part of your planning grant part 2), (c) control group(s) if applicable, (d) outcome measures, and (e) data analysis plan if applicable. o Proposed Clinical Sites and Investigators. Provide a list. Letters of commitment are not required at this stage. o Gender, Minority & Children Issues - Proposed population description in terms of gender, minorities and children, justification for excluding any gender, minority or children, plans for recruitment outreach, as appropriate. o Human Subjects Issues - Ethical considerations for placebo/control groups, risk/benefit for the participants, availability of the requisite eligible patient pool. Appendix material will be limited to color/glossy copies of text figures. PART 2 - PLANNING GRANT (Approximately 10-13 pages) This part must be written using the PHS form 398 headings, and should include: a. Specific Aims for the planning period (examples include: We will prepare a Manual of Operations and Procedures , We will conduct meetings to address the following issues: , We will test recruitment strategies , We will organize essential safety committees , etc.). b. Background and Significance, including rationale for planning period, Why is the planning period needed? Why not start the trial now? c. Preliminary Studies - Not required, but if any preliminary work already completed is included, it should be relevant to the work proposed in the planning period, and to the trial proposed in Part 1. d. Research Design and Methods - Detailed approach for each Specific Aim of the planning period. Highlight any innovations applicable to the planning period. e. Human Subjects - Address all the required items on human subjects for anticipated issues arising in the planning phase. If no human subjects issues are involved during the planning period, state so. Appendix material will be limited to color/glossy copies of text figures. 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. 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 are 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 are 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 the 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 scientific or ethical 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 08, 2001, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA in response to which the application would be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIAMS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Tommy L. Broadwater, Ph.D. at the address listed under INQUIRIES by February 08, 2001. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. BUDGET INSTRUCTIONS Only budget for the planning period (part 2) should be presented. Direct costs may be requested in $25,000 modules, up to a total direct cost request of $75,000. ONLY ONE YEAR OF SUPPORT MAY BE REQUESTED. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: APPLICATION FORM PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $75,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested. This is not a Form page. o Under Personnel, list all project personnel involved in the planning period (part 2), including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative), each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title (NIAMS Clinical Trial Planning Grant) and number (RFA-AR-00-010) must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed, 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) At the time of submission, two additional copies of the application must be sent to: Dr. Tommy L. Broadwater Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 45, Room 5AS.25U Bethesda, MD 20892-6500 Telephone: (301) 594-4952 FAX: (301)-402-2406 Email: broadwat@exchange.nih.gov Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction that addresses the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIAMS staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique. Applications may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, are discussed, assigned a priority score, and receive a second level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 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 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. Please note that there may be high enthusiasm for the future trial (part 1) but little enthusiasm for the planning (part 2), or vice versa, or low enthusiasm for both, etc. Review committees should indicate their enthusiasm for the two sections separately (with only one priority score for the overall application). SPECIFIC REVIEW CRITERIA The criteria used to evaluate Clinical Trial Planning Grant applications are based on the "Specific Requirements," as spelled out in an earlier section of the RFA. The reviewers will provide a two-part critique on the application. o PART 1 - This will be a brief critique of the future clinical trial, and will be based upon the items requested under part 1 of Special Requirements of this RFA. General enthusiasm (low, medium, high) about the proposed trial should be based on the following: (1) Significance: Would the future clinical trial address an important problem? Would conduct of the trial influence standard of care, develop a new therapy, or provide a better understanding of the disease? Is there convincing rationale to conduct the trial? (2) Investigator: Is the investigative team qualified to conduct the clinical trial? (3) Feasibility: Do the research design and methods appear appropriate and reasonable for the successful conduct of the proposed trial? (Please note that detailed research design and methods are not required.) (4) Human Subjects: Only major ethical concerns surrounding human subjects should be noted. o PART 2 - This will be a detailed critique of the planning period activities, and will be based upon the items requested under part 2 of Special Requirements of this RFA. (1) Significance: Will the proposed planning process address major barriers in conducting the future clinical trial? Is the planning period necessary? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) 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)? (5) Environment: Does the environment in which the work will be done contribute to the probability of success? Do the proposed Aims take advantage of unique features of the environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) Gender, Minorities, and Children: (Applicable only if human subject issues are involved in the planning period.) The adequacy of plans to include both genders, minorities, and children as appropriate for the scientific goals of the research will be evaluated. (7) Human Subjects: (Applicable only if human subject issues are involved in the planning period) Ethical issues surrounding human subjects will also be evaluated. SCHEDULE Letter of Intent Receipt Date: February 8, 2001 Application Receipt Date: March 19, 2001 Peer Review Date: TBA (June/July 2001) Council Review: September 24, 2001 Earliest Anticipated Start Date: December 1, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to one of the following persons, according to scientific area: Dr. Joan McGowan Bone Diseases 45 Center Drive, Room 5AS-43E Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: Joan_Mcgowan@nih.gov Dr. Alan N. Moshell Skin Diseases 45 Center Drive, Room 5AS-25L Bethesda, MD 20892-6500 Telephone: (301) 594-5017 FAX: (301) 480-4543 Email: Alan_N_Moshell@nih.gov Dr. James S. Panagis Orthopaedics 45 Center Drive, Room 5AS-37K Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 594-4543 Email: James_Panagis@nih.gov Dr. Susana A. Serrate-Sztein Rheumatic Diseases 45 Center Drive, Room 5AS-37G Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: Susana_Serrate-Sztein@nih.gov Direct inquiries regarding review issues to: Tommy L. Broadwater, Ph.D. Scientific Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-25U 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-4952 FAX: (301) 480-4543 Email: Tommy_Broadwater@nih.gov Direct inquiries regarding fiscal matters to: Melinda Nelson Grants Management Office National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-49F, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: nelsonm@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846. 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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