NIH Clinical Trial Planning Grant Program (R34)

NATIONAL INSTITUTES OF HEALTH
Office of Extramural Research

Introduction

Introduced in the Fall of 2003, the NIH Clinical Trial Planning Grant Program was developed to provide support for the development of Phase III clinical trials. This program supports 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.

Some of the non-participating ICs may solicit R34 applications using Requests for Applications (RFAs) or special Program Announcements (PAs) in order to meet specific programmatic needs. In some cases those announcements may specify different application characteristics, review criteria, and receipt dates. All such announcements will be published in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/index.html. The PA for investigator-initiated R34 applications can be found at http://grants.nih.gov/grants/guide/pa-files/PA-04-008.html and articulates the policies and procedures that apply to this program. Applications that are assigned to an IC that does not participate in this program may be returned without review.

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 the development of other essential elements of a clinical trial as defined by the individual participating ICs.
lead to the timely submission of an application for support of a full-scale trial, incorporating the elements developed under the 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 the rationale for the future clinical trial, documenting the significance and need to perform the trial.
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