and Human Services (HHS)
EXPIRED
NINDS CLINICAL TRIAL PLANNING GRANT RELEASE DATE: January 7, 2003 PA NUMBER: PAR-03-051 (see correction NOT-NS-04-010) March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. A replacement R34 (PAR-06-460) funding opportunity announcement has been issued for the submission dates after June 1, 2006. EXPIRATION DATE: Dec 16, 2005, unless reissued. APPLICATION RECEIPT DATES: April 15, August 15, and December 15 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces PAR-01-118 The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. The purpose of the NINDS Clinical Trial Planning Grant is to provide support for the organization of activities critical for the successful implementation of high-risk, complex, or large-scale clinical trials. The planning grant is intended to (a) allow for early peer review for the rationale and design of the proposed clinical trial; (b) provide support for the development of a detailed manual of operations and procedures; and (c) provide support to develop essential elements of a clinical trial, such as adequate plans for recruitment of patients, experimental design and protocols, data management, analytical techniques, facilities, administrative procedures, obtaining IND/IDE, and collaborative arrangements. The purpose of the NINDS planning grant is not to obtain preliminary data or to conduct pilot studies to support the rationale for the clinical trial. RESEARCH OBJECTIVES The NINDS encourages clinical research to evaluate interventions to treat and prevent neurological disease. The NINDS has established the Clinical Trial Planning Grant because extensive efforts are required to develop a detailed study protocol and to organize an effective research group. After the basic design and rationale for a neurological treatment trial has been reviewed, the NINDS Clinical Trial Planning Grant supports the development of specific elements which will be essential to conducting a successful full-scale clinical trial, including adequate plans for recruitment of patients, experimental design and protocols, data management, analytical techniques, 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 pilot studies to support the rationale for the clinical trial. The expected product of the planning grant is a detailed clinical trial research plan including a complete manual of operations and procedures. Included in the planning grant application must be a completed study protocol and projected direct costs for the future phase III trial. This estimate, broken down by year, should be included in the research plan of the application. MECHANISM(S) OF SUPPORT This PA will use the NIH Developmental Planning Grant (R21) award mechanism. (Note: NIH is planning to issue a generic announcement for clinical trial planning grants, which will then supercede this specific announcement). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This grant mechanism provides up to $150,000 in direct costs for a single year. The award cannot be renewed. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign 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. SPECIAL REQUIREMENTS The Research Plan of the application must contain the following four elements described below. For details of these four elements, see the REVIEW CRITERIA section of this PAR. o Rationale/Significance Provide the rationale for the future clinical trial and give information documenting significance and need to perform the clinical trial. The application should also include the specific aims for the planning period. The projected direct costs, broken down by year, must be included with the rational for the future trial. o Experimental Design The application for the planning grant must include a full protocol for the future clinical trial, including such elements as the following: (a) intervention(s) and mode(s) of delivery; (b) study design, treatment group(s), trial size, and inclusion/exclusion criteria; (c) control group(s) if applicable; (d) outcome measures; and (e) data analysis/management plan. A full descriptive template for a study protocol submitted for a NINDS planning grant can be seen at the following URL: http://www.ninds.nih.gov/funding/research/clinical_research/protocoltemplate.htm o Plans to Address Patient Recruitment/Retention The application must address the availability and population description of the requisite patient population (including gender, minorities, and children) and plans for recruitment outreach and follow-up. o Investigators The application must include a description of the leadership and proposed organization of the clinical trial, including proposed clinical sited (letters of commitment are not required at this stage). WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: John R. Marler, M.D. Associate Director for Clinical Trials National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2216 Bethesda, MD 20892-9520 Telephone: (301) 496-9135 Fax: (301) 480-1080 Email: [email protected] Scott Janis, Ph.D., Clinical Trials Program Analyst National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2210 Bethesda, MD 20892-9520 Telephone: (301) 496-9135 Fax: (301) 480-1080 Email: [email protected] o Direct your questions about peer review issues to: Katherine Woodbury-Harris, Ph.D. SRA, Scientific Review Branch NSC/NINDS/NIH 6001 Executive Boulevard Bethesda, MD 20892-9529 Telephone: (301) 496-5980 Fax: (301) 402-0182 E-mail: [email protected] o Direct your questions about financial or grants management matters to: Gladys Melendez Senior Grants Management Specialist NIH/NINDS/GMB/Suite 3290 6001 Executive Blvd. Rockville, MD 20892 Telephone: (301) 496-9231 Fax: (301) 402-0219 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent 6 weeks prior to the intended submission date. The letter of intent should be sent to (e-mail is acceptable): Scott Janis, Ph.D., Clinical Trials Program Analyst National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2210 Bethesda, MD 20892-9520 Telephone: (301) 496-9135 Fax: (301) 480-1080 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs 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. SENDING AN APPLICATION TO THE NIH: 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) The title, NINDS CLINICAL TRIAL PLANNING GRANT, and the number of this announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. At the same time of submission, mail two additional copies of the application to: Alan Willard, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Institute of Neurological Disorders & Stroke 6001 Executive Boulevard, Room 3208 Bethesda, MD 20892-9529 Rockville, MD 20852 (Courier service only) Telephone: (301) 496-9223 Fax: (301) 402-0182 E-mail: [email protected] The submission, review, and award schedule is: Submission deadline NINDS Review Council Earliest Funding April 15 Jun/Jul Sept/Oct Dec 1 August 15 Oct/Nov Jan/Feb Apr 1 December 15 Feb/Mar May/Jun Jul 1 APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates listed on the face page of the PA. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Complete applications for this PAR will be assigned to evaluated for scientific and technical merit by the NINDS clinical trials special emphasis study group (NSD-K) in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm.) As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Neurological Disorders and Stroke Advisory Council REVIEW CRITERIA Under the scope of the NINDS planning grant, the scientific review group will address and consider the research project using the four criteria listed below. Each of these criteria will be addressed and considered by the reviewers in assigning your application's overall score. Your 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, you may propose to carry out important work that by its nature is not innovative but may have an important health impact in clinical practice. Each of the following criteria will be addressed and considered in the assignment of the overall scientific merit rating. (1) RATIONALE/SIGNIFICANCE: o Is there adequate information to determine the significance and need to perform a future full-scale randomized clinical trial (RCT)? o Are adequate reasons presented for selection of intervention and mode of delivery, and for selecting particular doses or procedures? o Is there adequate information provided regarding the biological mechanisms and clinical data that support conducting an RCT? o Did the applicant present a compelling case for a need to proceed with an RCT as soon as possible? o Did the applicant adequately explain the impact of the future RCT on health care? o Was there adequate discussion included of advantages and disadvantages of competitive therapies? o Is the discussion of the ethical issues surrounding an RCT and the disease under study complete and thorough, and are there adequate safeguards in place to protect the welfare of human subjects? o Did the applicant provide the estimated direct costs of the future Trial? (2) EXPERIMENTAL DESIGN: o Are the conceptual framework, design, methods, and analyses adequately developed and appropriate for the aim of the future RCT? o In evaluating the experimental design, the reviewers will consider the adequacy of the following: 1) translation of the clinical question into a statistical hypothesis; sample size and duration of the RCT; 2) selection of endpoint(s) and data to be collected; 3) randomization and masking; and inclusion/exclusion criteria; 4) strengths and weaknesses of the proposed methods, and possible alternatives; 5) ancillary therapies; 6) capability to develop methods for standardization of procedures for data management and quality control. (3) PLANS TO ADDRESS PATIENT RECRUITMENT/RETENTION: o Are there adequate plans for documenting the availability of the requisite eligible patient pool and for including women, children, and minority individuals, (as appropriate) as trial participants? o Has the applicant provided adequate plans for recruitment outreach, as appropriate, and for follow-up procedures to ensure collection of data at stated intervals? (4) INVESTIGATORS: o Is there a clear statement of the leadership and proposed organization of the RCT, including: identification of a principal investigator, and for multi-center trials, a core of potential center investigators? o Is there evidence of professional training and experience of the RCT organizers in such areas as the clinical problem under study, administration of complex projects, and study design? o Are there plans for inclusion of statisticians, data managers and study coordinators? o Has the applicant developed plans to add or drop centers? o Are there adequate plans for essential committee structure, i.e., Planning, Steering, and Executive committees? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 and 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. Furthermore, we caution reviewers 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 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.853, 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. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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