OpportunityTitle: NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply  Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: This Funding Opportunity Announcement (FOA) is to support studies that are scientifically essential, yet also sufficient, for investigators to make definitive decisions that inform the final designs of important Phase II and beyondclinical trials within NHLBI&apos;s mission; that is, clinical trials with the primary intent of testing the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and treatment of heart, lung, blood, and sleep disorders. This mechanism may be used to test the feasibility of novel and efficient (pragmatic) trial designs, as well as determine the feasibility of an intervention, intervention parameters, subject availability, or other information essential to complete the design of a trial. Applications should demonstrate that the proposed studies are both necessary and sufficient to permit definitive decisions about the final design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations,to develop infrastructure for a clinical trial, or implement a fully designed trialwill not be considered appropriate for this announcement. Please note that NHLBI supports other funding opportunities for clinical trials-see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization for information on other NHLBI clinical trial funding opportunity announcements. In contrast to the planning or study start up phase of other NHLBI clinical trial FOAs, the R34 mechanism is intended to provide new i?n?f?o?r?m?a?t?i?o?n that answers a scientific question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial.
GrantorContactEmailDescription: If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV