The PRMRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on a disease or condition addressed in at least one of the Congressionally directed FY20 PRMRP Topic Areas.

Clinical trials may be designed to evaluate promising

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new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies.

Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

This outcome represents a direct effect on the subject of that intervention or interaction.

The term "human subjects" is used in this Program Announcement to refer to individuals who will be recruited for or who will participate in the proposed clinical trial.

For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.

Applicants seeking funding for a preclinical research project should consider one of the other FY20 PRMRP Program Announcements being offered.

Funding from this award mechanism must support a clinical trial and cannot be used for animal studies.

Two different application categories, based on the phase of planning for the clinical trial, are available under this Program Announcement