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NIDCD Clinical Trial Planning Grant RELEASE DATE: August 27, 2002 PA NUMBER: PAR-02-158 EXPIRATION DATE: October 1, 2005 National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.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 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: The National Institute on Deafness and Other Communication Disorders (NIDCD) is committed to fostering the development, and funding, of meritorious applications seeking to improve health by supporting well-executed phase III clinical trials (see definition in PHS 398 rev. 5/2001) in its mission areas of hearing, balance, smell, taste, voice, speech and language. Investigators who submit applications for phase III clinical trials for consideration by the NIDCD (see the NIDCD Investigator- Initiated Phase III Clinical Trials Program Announcement at (http://grants.nih.gov/grants/guide/pa-files/PA-02-157.html) are expected to provide detailed information regarding the study rationale, design, protocols and procedures, and collaborative arrangements. Much of this information is best presented in a complete Manual of Operations and Procedures (MOP) submitted as part of the application. It is recognized that the development of a MOP is a time-consuming and expensive activity. The NIDCD Clinical Trial Planning Grant is intended to help support this and other related activities necessary to develop a clinical trial. The Planning Grant also allows for peer review of the rationale for, and design of, clinical trials of interventions aimed at preventing or treating diseases and disorders of hearing, balance, smell, taste, voice, speech and language. Applicants should be aware that the award of a Clinical Trial Planning Grant does not guarantee NIDCD acceptance of the full-scale phase III clinical trial for peer review, nor subsequent funding of the trial following peer review. It is expected that the applicant will develop a full-scale phase III clinical trial application if the Clinical Trial Planning Grant is funded. This PA supersedes PAR–00-007 (October 20, 1999). RESEARCH OBJECTIVES The objective of the NIDCD Clinical Trial Planning Grant is to address preliminary design and methodological issues for specific clinical trials intended to evaluate interventions for the treatment or prevention of disease and disorders of hearing, balance, smell, taste, voice speech and language. The NIDCD Clinical Trial Planning Grant supports the development of specific elements essential to the conduct of a successful phase III clinical trial, particularly one that involves multiple centers. Examples of these elements include 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 for 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). MECHANISM OF SUPPORT This PA will use the NIH R21 award mechanism, which will provide up to $100,000 in direct costs for one year. The award cannot be renewed. 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). 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 (domestic applications may include a foreign component; however, the domestic component must constitute the majority of the application). Foreign institutions are not eligible to apply. 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. 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: Staff Contact: A. Julianna Gulya, MD Division: Division of Extramural Research Institute: NIDCD Building: EPS Room 400D Bethesda, MD 20892-7180 Telephone: (301) 435-4085 FAX: (301) 402-6251 Email: gulyaj@mail.nih.gov o Direct your questions about peer review issues to: Name: Craig Jordan, PhD Division: Division of Extramural Research Institute: NIDCD Building EPS, Room 400C Bethesda, MD 20892-7180 Telephone: (301)496-8683 FAX: (301) 402-6250 Email: jordanc@mail.nih.gov o Direct your questions about financial or grants management matters to: Name: Sara Stone Division: Division of Extramural Research Institute: NIDCD Building EPS, Room 400B Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: stones@nidcd.nih.gov 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) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. As with most applications to NIH, the research plan is limited to 25 pages. All information for review of the NIDCD Clinical Trial Planning Grant application must be included in the body of the application; appendices will not be considered during the review for this mechanism. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 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) In order to facilitate the review of applications assigned to the NIDCD, the applicant should, at the same time, mail or deliver TWO copies of the application to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders EPS, 400C Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened 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: 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 appropriate national advisory council or board 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. 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 is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? 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 or the environment, to the extent they may be adversely affected by the project proposed in the application. In keeping with NIH policy (see "MONITORING PLAN AND DATA SAFETY AND [sic] MONITORING BOARD" below) all clinical trials require data and safety monitoring. 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) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: (1) Rationale. The background and significance of the application must address the rationale for the future phase III clinical trial (CT) including: o a clear statement of the question that the CT would address; o information adequate to determine the significance and timeliness of, as well as the need to perform, the CT; o the biological mechanisms and clinical data that support conducting a CT; o impact on health care; o reasons for selection of intervention and mode of delivery, including specific details such as dose or a particular procedure; o competitive therapies including both clinical and economic advantages and disadvantages of each; and, o the ethical issues surrounding the CT and the disease/condition under study. (2) Study Design. The application for a planning grant must include a full description of the experimental design of the CT, including such elements as the following: o translation of the clinical question into a statistical hypothesis; o endpoint(s) and data to be collected including relevance to the clinical and statistical hypothesis being tested; o sample size and duration of the CT; o randomization, masking (if appropriate), and inclusion/exclusion criteria; o strengths and weaknesses of the proposed methods and possible alternatives; o ancillary therapies; o plans to standardize and monitor adherence to the clinical protocol in each center; and, o methods for standardization of procedures for data management and quality control. Whereas the criteria listed above apply to all clinical trials, there are specific issues of particular relevance to multicenter trials, which must also be addressed, such as standardization/quality control of, and adherence to, the clinical protocol and data collection or distribution guidelines, and the use of a data coordinating center. (3) Plans for Patient Recruitment/Retention. The application must include an assessment of the following items: o availability of the requisite eligible patient pool; o availability of children, women and minority individuals as trial participants and specific recruitment and retention plans for their inclusion; o the status of evidence showing whether or not clinically important sex/gender and race/ethnicity differences in the intervention effect are to be expected (see INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH below) ; and, o plans for recruitment outreach and, as appropriate, follow-up procedures to ensure collection of data at stated intervals. (4) Investigators. The application must include a clear statement of the leadership and proposed organization of the CT, including: o identification of a principal investigator, and, for multicenter trials, a core of potential center investigators and staffing for a coordinating center; o professional training and experience of the CT organizers in such areas as the clinical problem under study, administration of complex projects and study design; o inclusion of statisticians, data managers and study coordinators; o plans to add or drop centers; o essential committee structure appropriate to the complexity of the trial (e.g., Planning, Steering, Executive Committees); and, o for multicenter trials, the organizational structure of the trial, especially the organizational relationships among the enrollment centers and between the coordinating center and the enrollment centers. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. 93.173, 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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