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ID#: PAR-10-184     Posted: 15 Mar 2011
NIAID Clinical Trial Implementation Grant (R01) PAR-10-184
Deadline: 14 Jan 2013
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Type of Grant: Other
Topics/Fields of Support: Social, ethical, access and regulatory issues, Other
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

Funding Opportunity Description

1. Research Objectives
This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for implementation of investigator-initiated non-high-risk 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 proposed trial must be hypothesis-driven, related to the research mission of the NIAID and address a research area considered a high priority by the Institute. 

This FOA will utilize the NIH research project (R01) award mechanism, and runs in parallel with two related FOAs, PAR-10-185 and PAR-10-186,, that invite applications for NIAID Clinical Trial Planning (R34) Grants, which support planning activities for investigator-initiated clinical trials, and  NIAID Clinical Trial Implementation (U01) Cooperative Agreements, which  support implementation of investigator-initiated, high-risk clinical trials, respectively.

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 to furthering the Institute’s research, NIAID recognizes that additional models of clinical research may be important to advancing its research mission; therefore, NIAID 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 (PAR-10-185) is not a prerequisite for either NIAID implementation award.   If a clinical trial is ready for implementation, and readiness is adequately supported by documentation, submission of an R01or U01 application may occur if prior approval has been provided by NIAID. 

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

Scope 

The NIAID Clinical Trial Implementation (R01) Grant supports implementation of trials that address high priority research related to the mission and goals of NIAID and that are considered non-high-risk by the NIAID.

A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:   

  • provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
  • administration of an unlicensed product; or
  • administration of a licensed product for an unapproved indication.

A non-high-risk trial would not have any of the attributes listed above; for example, it would involve provision of a routine intervention and administration of a licensed product for an approved indication. For the purposes of this FOA, examples of routine interventions might include, but would not be limited to: liver biopsy only to measure a research outcome and provision of anti-inflammatory agents and/or immunosuppressants to suppress and prevent transplant rejection, etc.

Implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:

  • training of study personnel;
  • enrollment and recruitment of study subjects;
  • data collection, management and quality control;
  • laboratory work and data analyses;
  • study management and oversight;
  • establishment of committees to manage the complexity of the trial
  • preparation of the final study report; and
  • other related post-enrollment activities.

Each NIAID Clinical Trial Implementation (R01) award will support the implementation of a single clinical trial.  Applications that include more than one clinical trial will not be reviewed.

Applicants must propose a time-sensitive, milestone-driven clinical trial and describe the clinical trial stages, criteria for completion of the stages and contingency plans for each stage.  Any anticipated impediments that could require a revision in the timeline must be identified and accompanied by a discussion of alternative approaches. The trial must be hypothesis- driven, include a randomized design, and have clear primary and secondary endpoints.  A description of the study population, why it is an appropriate group to study the research question(s) posed, subject eligibility, inclusion and exclusion criteria, and a feasible recruitment and enrollment plan must also be included. Statistical methods appropriate for the study design, and adequate plans for data monitoring and safety are required.  An overview of the state of the science, current status and relevance of the trial, and discussion of the clinical protocol must be presented in the application.

All clinical trial planning activities must be completed by the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

NIAID reserves the right to specify: 1) whether an IND/IDE application should be submitted to an appropriate regulatory agency; and 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE.

Investigators are referred to NIAID’s Clinical Research Toolkit website (http://www3.niaid.nih.gov/LabsAndResources/resources/toolkit/default.htm) for protocol templates and guidance, clinical research resources, and links to program divisions.   Investigators are strongly encouraged to contact NIAID’s program divisions (Section VII.1. Scientific/Research Contacts) for information rearding division-specific clinical research policies and procedures.

Milestones

Delineation of milestones is a key characteristic of the NIAID Clinical Trial Implementation (R01) Grant. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity.

Applications must include a series of milestones for completion of the clinical trial and provide contingency plans should there be delays in attaining them.  The milestones will undergo peer review and will be incorporated into the terms of award.

NIAID R01 clinical trial implementation grants will NOT support clinical trial planning tasks such as:

  • Development of study design
  • Identification of collaborators and enrollment sites
  • Development of the clinical protocol and informed consent
  • Development of the statistical analysis plan
  • Development of the data management plan
  • Development of the Investigator’s brochure or equivalent

Investigators seeking support for the planning and design of clinical trials should refer to the NIAID Clinical Trial Planning (R34) Grant FOA (PAR-10-185).

NIAID R01 clinical trial implementation grants will NOT support high-risk clinical trials.  Investigators seeking support for high-risk clinical trials should refer to the NIAID Clinical Trial Implementation (U01) Cooperative Agreement FOA (PAR-10-186).

NIAID R01 clinical trial implementation grants will NOT provide support for clinical trials that fall outside the mission and high-priority research areas of the NIAID.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

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 (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor 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 seehttp://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).  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.

Renewals.  Renewal applications may not be submitted under this FOA.

Pre-approval.  Pre-approval from NIAID is required for submission of the NIAID Clinical Trial Implementation (R01) 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 trial.  Technical and scientific merit will be determined during peer review. Applicants whose projects do not meet NIAID’s programmatic needs or are not appropriate as investigator-initiated clinical trials, will not be granted permission to submit an application. If the NIAID ascertains that substantial staff involvement may be necessary, submission of the application may be considered under the Clinical Trial Implementation (U01) Cooperative Agreement FOA (PAR-10-186), but will not be considered under this FOA.   NIAID reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by NIAID.

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





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