NIH – NHLBI Clinical Trial Pilot Studies (R34)

November 24, 2015 by School of Medicine Webmaster   |   Leave a Comment

This is a reissue of an existing program. The purpose of this FOA is to support pilot studies for the acquisition of data critical to complete the design of a full-scale trial. The goal is that the proposed R34 pilot studies will yield information that is both necessary and sufficient to permit the design of the clinical trial. Examples of research topics include but are not limited to the following:

  • Perform studies to determine the appropriate study population, intervention, or outcome.
  • Collect information necessary to estimate available populations, attrition rate, or response rate.
  • Refine the intervention.
  • Test the feasibility of an outcome or intervention in the field.
  • Determine whether adequate adherence to a treatment is achievable.
  • Standardize and validate survey instruments.
  • Standardize and test effectiveness of training tools.
  • Adapt and test a survey instrument or protocol for a population that differs culturally from the population for which the instrument was originally designed.

It is anticipated that, if indicated, applicants will have appropriate U.S. Food and Drug Administration approval and any necessary agreements. This FOA is intended to support applications that address research questions that are within the mission of the NHLBI; research questions addressing prevention or treatment of malignancies are not within NHLBI’s mission. This FOA is not intended to support first-in-human studies. Applications that are first-in-human studies, propose solely to write a protocol or manual, develop infrastructure, are mechanistic, or are animal studies are not appropriate for this FOA.

Deadlines:  standard dates apply


Filed Under: Funding Opportunities



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