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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

Scope

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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Popular Q&A

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What entity or individual is the responsible party for an applicable clinical trial supported by an NIH grant (including cooperative agreements)?


The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. NINDS supports both pilot clinical trials and clinical trials planning grants. The purpose of the NINDS Pilot Clinical Trial Grant For Neurological Disease is to obtain preliminary data and conduct studies to support the rationale for a subsequent full-scale clinical trial. The NINDS Clinical Trial Planning Grant allows for early peer review of the rationale and design for clinical trials of treatments for neurological disorders and provides support for the …

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