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ID#: PAR-10-185     Posted: 15 Mar 2011
NIAID Clinical Trial Planning Grant (R34) PAR-10-185
Deadline: 14 Jan 2013
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Type of Grant: Other
Topics/Fields of Support: Clinical trial site challenges, Prevention strategies, Social, ethical, access and regulatory issues
National Institute of Allergy and Infectious Diseases, NIH, HHS

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID is one of the 27 Institutes and Centers of the National Institutes of Health (NIH). NIH, like the Centers for Disease Control and Prevention (CDC), is part of the U. S. Department of Health and Human Services (HHS). NIH is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, please visit NIH (www.nih.gov).


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DETAILS

Research Objectives: This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites applications that propose planning, design, and preparation of documentation necessary for implementation of investigator-initiated clinical trials.  A clinical trial is defined by NIH as:

“a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective”.

The NIAID Clinical Trial Planning Grant will support planning for clinical trials that address high-priority research questions related to the mission and goals of the NIAID.  Sufficient pre-clinical data to support the planning of the clinical trial should be available prior to submission of the R34 grant application.  The trials must be hypothesis-driven and milestone-defined

The NIAID Clinical Trial Planning (R34) Grant is not a prerequisite for submission of the R01 or U01 application for implementation of investigator-initiated clinical trials.

Background

In FY2009 NIAID funded $1.36 billion in clinical research.  A subset of this funding was devoted to clinical trials, which is one research strategy NIAID uses to improve the understanding of the clinical mechanisms of infectious, immunologic, and allergic diseases and to improve prevention, diagnosis, and treatment.  For additional information about the mission, strategic plan, and research interests of the NIAID, applicants are encouraged to consult the NIAID web site http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.

Clinical Trial Infrastructure

Historically, NIAID has supported a wide variety of clinical research activities through a clinical trial infrastructure funded through cooperative agreements, solicited under NIAID Requests for Applications (RFAs), and contracts, solicited under NIAID Requests for Proposals (RFPs).  This infrastructure focuses on high-priority disease research areas.   Examples include the HIV/AIDS Clinical Trial Networks supported by the Division of AIDS (http://www3.niaid.nih.gov/about/organization/daids/Networks/daidsnetworks.htm), the Division of Microbiology and Infectious Diseases Clinical Trials Programs and Networks (http://www3.niaid.nih.gov/about/organization/dmid/programs.htm), and the Immune Tolerance Network supported by the Division of Allergy, Immunology and Transplantation (http://www.immunetolerance.org/).   NIAID’s clinical research infrastructure includes coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources.    

Investigator-Initiated Clinical Trials

Although the clinical research infrastructure is crucial in furthering the Institute’s research, NIAID recognizes that additional models of clinical trial research may be important in furthering its goals for the next decade.  Within this framework, the Institute has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial infrastructure.  This program consists of support for the NIAID Clinical Trial Planning (R34) Grant, the NIAID Clinical Trial Implementation (R01) Grant and the NIAID Clinical Trial Implementation (U01) Cooperative Agreement.   The NIAID Clinical Trial Implementation (R01) Grant (PAR-10-184) is designed to support non-high-risk clinical trials, while the NIAID Clinical Trial Implementation (U01) Cooperative Agreement (PAR-10-186) is designed to support high-risk clinical trials, as defined by NIAID below and in the associated policy statement (see NOT-AI-10-024).  

The NIAID Clinical Trial Planning Grant (R34) is available to support planning activities associated with either high- or non-high-risk clinical trials.  However, the NIAID Clinical Trial Planning (R34) Grant is not a prerequisite for either NIAID implementation award. The planning grant is designed to:  (1) permit early peer review of the rationale for the proposed clinical trial; (2) permit assessment of the design/protocol of the proposed trial in a preliminary form; (3) provide support for the development of a complete study protocol and associated documents, including a manual of operations and (4) support the development of other essential elements of a clinical trial. If a clinical trial is ready for implementation, and readiness is adequately supported by documentation, submission of an R01 or U01 application may occur if prior approval has been provided by NIAID.  Note that funding of the Clinical Trial Planning Grant does not guarantee or imply pre-approval to submit an application for or funding of a subsequent NIAID Clinical Trial Implementation (R01) Grant or  NIAID Clinical Trial Implementation (U01) Cooperative Agreement.  

For additional information about NIAID’s investigator-initiated clinical trial program, see http://funding.niaid.nih.gov/ncn/clinical/iict.htm.

Although the NIAID Clinical Terms of Award will not be applied to planning grant awards, applicants are encouraged to review the NIAID Clinical Terms of Award and associated guidance documents while preparing applications for submission under this FOA (see http://www.niaid.nih.gov/ncn/clinical/clinterm.htm).

Scope

The NIAID Clinical Trial Planning (R34) Grant will support timely development of all materials required for implementation of the future clinical trial.  

Awards made under this FOA will support all clinical trial planning activities, including, but not limited to:

  • establishment of the research team
  •   identification of collaborators and enrollment sites
  • design of the study
  • development of the complete clinical protocol
  • development of the statistical analysis plan
  • development of the data management plan
  • development of the informed consent(s) and assent, if applicable,  form(s)
  • development of the investigator’s brochure or equivalent
  • development of a manual of operations
  • development of a data sharing plan
  • development of milestones
  • development of a plan for the acquisition and administration of study agent(s)
  • obtaining required Office of Human Research Protections (OHRP) assurances, if not already in place
  • determination of whether the trial will be conducted under an IND/IDE and who will hold the IND/IDE (NIAID reserves the right to decide whether the applicant should apply for an IND/IDE, as well as the right to hold the IND/IDE.)
  • development of a complete set of suitable documents for submission to the appropriate regulatory authorities
  • development of a data and safety monitoring plan
  • development of a detailed budget for conduct and completion of the clinical trial including funding for preparation of a final study report
  • development of training materials and training plans for study staff

The R34 planning grant will not support planning for more than one clinical trial or collection of preliminary (clinical or pre-clinical) or prospective data to support the rationale for a clinical trial.

See grant posting webpage on NIH website for application details.

ELIGIBILITY

Application Due Date(s) for AIDS & Non-AIDS:May 13, 2011, September 13, 2011, January 13, 2012, May 14, 2012, September 13, 2012, January 14, 2013

Eligibility Information

1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply:

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
  • State Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribally Designated Organizations
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • U.S. Territory or Possession
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Organizations)
  • Other(s):
    • Eligible Agencies of the Federal Government
    • Faith-based or Community-based Organizations.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such applications must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. Resubmissions require pre-approval by the NIAID.

Applicants who submitted a new application in response to PAR-06-384 may submit a resubmission application in response to this FOA.

Renewals. Renewal applications are not allowed under this FOA. 

Pre-approval.  Pre-approval from NIAID is required for submission of the NIAID Clinical Trial Planning (R34) Grant application, including new and resubmission applications.   NIAID staff will consider whether the proposed clinical trial meets the goals and mission of the Institute and whether it is appropriate to conduct it as an investigator-initiated clinical trial, but will not evaluate the technical and scientific merit of the proposed planning grant or associated  trial.  Technical and scientific merit will be determined during peer review. Applicants whose projects are not appropriate as investigator-initiated clinical trials, will not be granted permission to submit a planning grant application. NIAID reserves the right to determine that support for planning of  clinical trials may be obtained through other mechanisms.

CONTACT INFORMATION

Agency Contacts:

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Matthew J. Fenton, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 6503, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973, Fax: (301) 480-5824
Email: fentonm@niaid.nih.gov  

Mr. Martin Gutierrez
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases
Room 4258, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 451-2703, Fax: (301) 402-1506
Email: mgutierrez@niaid.nih.gov

Ms. Elizabeth Holloman
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4504, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-8339, Fax: (301) 480-0728
Email: hollomone@niaid.nih.gov

2. Peer Review Contact(s):

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Telephone: (301) 435-9369, (301) 496-2550, Fax:  (301) 480-2408
Email: pm158b@nih.gov  

3. Financial/Grants Management Contact(s):

Ms. Laura Eisenman
Division of Extramural Activities
National Institute of Allergy and  Infectious Diseases
Room 2120, MSC-7614
6700-B Rockledge Drive
Bethesda, Maryland 20892-7614
Telephone: (301) 402-5541, Fax:  (301) 493-0597
Email: le55d@nih.gov