OpportunityTitle: Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (PTC) (U01)
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 not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Description: This funding opportunity announcement (FOA) requests U01 applications proposing a single, pragmatic clinical trial in adults with chronic pulmonary diseases. Each successful applicant will serve as a Protocol Leadership Group (PLG) for a new type of clinical research network: the Pulmonary Trials Cooperative (PTC). The PTC is a cooperative program that includes multiple PLGs and a Network Management Core (NEMO). The PTC is designed to conduct multiple clinical trials in both inpatient and outpatient settings in adults with a variety of chronic pulmonary diseases, including but not limited to interstitial lung disease (ILD), pulmonary hypertension (PH), chronic obstructive pulmonary disease (COPD), sarcoidosis, and obstructive sleep apnea, but excluding asthma and acute lung injury and critical care. Studies, which may include both Phase 2 and Phase 3 simple, pragmatic clinical trials, will evaluate the efficacy or effectiveness of promising new or existing therapies. This FOA solicits applications for PLGs, which will have primary responsibility for developing a protocol and supporting a Lead Investigator for that protocol in the conduct and analyses of the related trial. A companion FOA (RFA-HL-15-016) requests applications for NEMO.
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