Source: http://grants1.nih.gov/grants/guide/pa-files/PAR-02-119.html
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PAR-02-119: CLINICAL TRIAL PLANNING GRANT
PA NUMBER: PAR-02-119
EXPIRATION DATE: October 24, 2003, unless reissued. National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIAMS, (http://www.niams.nih.gov/)
Application Receipt Dates: October 24, 2002, June 24, 2003, and October 24, 2003.
PURPOSE OF THIS PA The purpose of the NIAMS Clinical Trial Planning Grant is to provide support for the organization of activities critical for the successful implementation of clinical trials in areas within the NIAMS mission. The planning grant is intended to (a) allow for early peer review of the rationale and design for high risk, complex, or large-scale clinical trials, (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, such as experimental design, analytical techniques, recruitment strategies, data management, and collaborative arrangements. The purpose of the NIAMS planning grant is not to obtain preliminary data, nor to conduct studies to support the rationale for the clinical trial.
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, or 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 is recommended for funding.
Complex, high risk, or large-scale clinical trials require extensive planning. The NIAMS Clinical Trial Planning Grant supports the development of specific elements essential to the conduct of a successful clinical trial. Examples of these elements include adequate plans for recruitment and retention of patients, experimental design and protocols, data management, analytical techniques, identification of facilities, administrative procedures, and collaborative arrangements. 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 application for a Clinical Trial Planning Grant. The purpose of the planning grant is not to obtain preliminary data or to conduct studies to support the rationale for the clinical trial. The expected product of the Clinical Trial Planning Grant is a detailed clinical trial research plan including a complete manual of operations and procedures (MOP). The NIAMS Clinical Trial Planning Grant is intended to help support this and other related activities necessary for a successful 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.
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 Evaluating 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.
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 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 PA.
MECHANISM(S) OF SUPPORT This PA will use the NIH R21 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). This is a one-year award, for up to a total direct cost request of $100,000.
o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Also, new investigators are encouraged to apply. They may wish to develop small, focused research projects that provide initial findings for larger research proposals in the future. It would be expected that such applications also would have smaller budgets reflecting the scope of the research proposed. SPECIAL REQUIREMENTS
The Research Plan should be presented in two parts as described below, and must be limited to 15 pages. Appendix material, with the exception of color glossy photographs, will not be accepted. Applicants are encouraged to address issues listed in "Review Criteria" and "Other Review Criteria" in this PA.
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.
Discussion of the below two topics are not subject to page limits.
o Gender, Minorities and Children Issues - Proposed population description in terms of gender, minorities and children, justification for excluding any gender, minority groups 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.
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.
Discussion of the below topic is not subject to page limits.
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.
We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. o Direct your questions about scientific/research issues to:
Dr. Deborah Ader
NIH, NIAMS, EP
Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: aderd@mail.nih.gov
Osteoarthritis Initiative & Diagnostic Imaging
Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: lester1@mail.nih.gov
Email: mcgowanj@mail.nih.gov Dr. Alan N. Moshell
Email: moshella@mail.nih.gov Dr. James S. Panagis
Email: panagisj@mail.nih.gov Dr. Susana A. Serrate-Sztein
Email: szteins@mail.nih.gov o Direct your questions about peer review issues to:
John Lymangrover, Ph.D.
Email: broadwat@mail.nih.gov
o Direct your questions about financial or grants management matters to: Melinda Nelson
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Because the CTPG applications are limited to $100,000 per year in direct costs, they must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened by NIAMS in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will:
PROTECTIONS: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application.
OTHER 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 this PA. The reviewers will provide a two-part critique on the application.
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 high enthusiasm for both, etc. Review committees should indicate their enthusiasm for the two sections separately (with only one priority score for the overall 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 PA. 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: Any concerns involving the participation of human subjects will 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 PA.
(1) Significance: Will the proposed planning process address major barriers in conducting the future clinical trial? Is the planning period necessary?
(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.
copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.846, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.