NHLBI Clinical Trial Pilot Studies
Funds pilot work that is both necessary and sufficient to plan a later phase II, III or IV trial โ with no further studies needed in between.
The demand in this notice is unusual, and it is a double one.
The work has to be **necessary** to plan a later phase II, III or IV trial โ the applicant must describe that planned trial and show this research is scientifically required to design it.
And it has to be **sufficient**. The results must inform the future trial without further studies. A pilot that would leave one more question open dโฆ
Studies both necessary and sufficient to inform the planning of a later phase II, III or IV clinical trial testing efficacy, safety, clinical management or implementation of interventions preventing or treating heart, lung, blood and sleep disorders, with the planned trial described and no further studies required in between. Clinical trials are optional.
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