Clinical Trial Development Continuum

NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health of millions of people suffering from heart, lung, and blood disorders. NIH has recently implemented a series of reforms and initiatives to improve the stewardship of clinical trials. More about those efforts can be learned here. By engaging the research community and a broad group of stakeholders and advisory groups, NHLBI has received input and has established a multi-pronged approach (see “Optimizing our Clinical Trials Enterprise”) that will make our clinical trials enterprise even stronger.

NHLBI’s new funding announcements will help lead investigators to more interpretable, timely, and useful results, which in turn will improve public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including pilot studies.

Opportunities and Announcements

Early Phase Clinical Trials for Therapeutics and/or Diagnostics

• PAR-21-119, NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

• PAR-21-118, NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)

Multi-Site Investigator-Initiated Clinical Trials (Phase II and above)

• PAR-22-192, Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials

• PAR-22-193, Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

Single-Site Investigator-Initiated Clinical Trials (Phase II and above)

• PAR-22-189, Single-Site Investigator-Initiated Clinical Trial

Pilot Study

• PAR-21-079, NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

Mechanistic Clinical Trials

• Per NOT-HL-19-690, NHLBI will only accept mechanistic studies that meet NIH’s definition of a clinical trial in response to PA-18-345 NIH Research Project Grant (Parent R01 Clinical Trial Required) and its reissues.

• PA-20-183, Research Project Grant (Parent R01 Clinical Trial Required)