NIH/NHLBI – NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

The NHLBI is committed to identifying effective treatments, as well as prevention and disease management strategies for heart, lung, blood and sleep disorders by supporting well-executed clinical trials. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, intervention, outcome, or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent successful study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, disease, or venue.  Preparatory studies may be needed to fill information gaps and address unknowns, thereby improving trial design and knowledge of trial feasibility.

The purpose of this FOA is to support studies for the acquisition of data critical to complete the protocol of a full-scale Phase II or beyond trial.  While the immediate goal is that the proposed R34 pilot studies will yield information that is both scientifically necessary and also sufficient to permit final decisions about the design of the clinical trial, NHLBI expects the published results also to be of value to the research community for future planning. Examples of research topics include but are not limited to the following:

  • Perform studies to refine the appropriate study population, intervention, or outcome.
  • Collect information necessary to estimate available populations, attrition rate, or response rate.
  • Standardize the intervention or outcome across multiple sites.
  • 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 an intervention or outcome 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 at the time of submission. 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 to write a protocol or manual, develop infrastructure, implement an already fully designed trial, are purely mechanistic, or contain animal studies are not appropriate for this FOA. NHLBI supports other funding opportunities for early phase clinical trials, development of innovative clinical trial designs and single and multi-site Phase II and beyond trials-see for information on other NHLBI clinical trial funding opportunity announcements.  Applicants are encouraged to review responses to Frequently Asked Questions (FAQs) prior to submission.

Deadlines:  standard dates and standard AIDS apply.  Letters of intent due 30 days prior to the deadline.