NIH clinical Trial Planning Grant Program
The NIH Clinical Trial Planning Grant Program (R34) supports development of Phase III clinical trials. This program supports
- establishment of the research team,
- development of tools for data management and research oversight
- definition of recruitment strategies,
- finalization of the protocol
- preparation of an operations/procedures manual
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.
This website describes the use of the investigator-initiated R34 and describes the NIH Institutes and Centers (ICs) that intend to accept such applications.
Parent R34 Application Characteristics
- a project period of one year
- a budget for direct costs of up to four $25, 000 modules or $100, 000 per year
- include a rationale for a future clinical trial, documenting significance and need.
- describe the potential impact of the clinical trial on health care, policy or practice.
- provide adequate information for reviewers to evaluate how the trial would be conducted
- address the availability and population description of the requisite patient population
- plans for recruitment outreach and follow-up
- address issues and challenges regarding adherence to the proposed intervention protocol
The planning grant is designed to:
- permit early peer review of the rationale for the proposed clinical trial;
- permit assessment of the design/protocol of the proposed trial in its current, early form;
- provide support for the development of a detailed MOP; and
- support development of essential elements of a clinical trial defined by the individual participating ICs.
- lead to an application for support of a full-scale trial, based on elements developed under the R34.
R34 Participating Institutes and Centers
R34 Non-Participating Institutes and Centers
ICs may solicit R34 applications using Institute/Center specific Funding Opportunity Announcements (FOAs) that may have different application characteristics, review criteria, and receipt dates. These announcements are published in the NIH Guide for Grants and Contracts at .
- NIH Institutes and Centers that DO NOT accept investigator initiated applications in response to this Parent R34 Announcement but ONLY accept Institute/Center specific Funding Opportunity Announcements for Clinical Trial Planning Grant: NCCAM, NCI, NCRR, NHGRI, NHLBI, NIAID, NIBIB, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR, NLM, and FIC.
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