NIH Clinical Trial Planning Grant Program (R34)

This Funding Opportunity Announcement (FOA) invites applications under the NIH Clinical Trial Planning Grant Program, the purpose of which is to provide support for the development of a Phase III clinical trial. This includes the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and other essential elements of the study included in a manual of operations/procedures. The Clinical Trial Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial. -All investigator-initiated grant applications described in this FOA will be assigned to NIH Institutes and Centers (ICs) according to standard Public Health Service (PHS) referral guidelines and specific program interests. -This FOA will use the Clinical Trial Planning Grant (R34) mechanism. -Special Research Interests: Investigators are strongly encouraged to consult the list of participating ICs and special research interests. See http://grants.nih.gov/grants/guide/contacts/pa-06-363_contacts.htm See also the NIH R34 Web site at http://grants.nih.gov/grants/funding/r34.htm. -Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. -Project Period and Award Levels: The total project period for an application submitted in response to this funding opportunity is one year. Direct costs of up to $100,000 may be requested for the one-year period -Renewal (formerly competing continuation or Type 2 ) applications are not permitted. -Eligible Organizations: For profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals and laboratories; Units of State government; Units of local government; Eligible agencies of the Federal government; Domestic institutions/organizations; Foreign institutions/organizations; Faith-based or community-based organizations; Indian/Native American Tribal government (Federally recognized); Indian/Native American Tribal government (other than Federally recognized); and Indian/Native American Tribally Designated Organization. -Eligible Project Directors/Principal Investigators (PDs/PIs): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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 support. -Applicants may submit more than one application, provided each application is scientifically distinct.