Multi Site Clinical Trials for the Pulmonary Trials Cooperative (PTC) (U01) | Apply Online

Opportunity Summary:

The NIH funding opportunity RFA-HL-15-015, titled "Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (PTC) (U01)," supports one main thing: a single, pragmatic, multi-site clinical trial in adults with chronic pulmonary disease. The award mechanism is a U01 cooperative agreement, which means the project is funded like a grant but carried out in close collaboration with NIH staff and within a larger coordinated program. Rather than funding a broad center or a portfolio of studies, this FOA is built around proposing one clearly defined clinical trial that can realistically be executed across multiple sites and that is designed to produce results with direct real-world clinical relevance.

A key feature of this FOA is that each funded application becomes a Protocol Leadership Group (PLG) within a larger clinical research network called the Pulmonary Trials Cooperative (PTC). The PTC is structured as a cooperative program made up of multiple PLGs (each responsible for its own trial protocol) plus a separate Network Management Core known as NEMO. In practical terms, PLGs are the groups that originate, refine, and lead specific trials, while NEMO provides centralized network operations and coordination. NIH designed this model to make it easier to run several pragmatic pulmonary trials in parallel, using a shared network infrastructure rather than rebuilding trial operations from scratch each time. A companion FOA (RFA-HL-15-016) solicits applications specifically to operate NEMO, while this FOA focuses only on the PLGs.

The types of studies envisioned are "simple, pragmatic" clinical trials that may fall into Phase 2 and Phase 3 categories. The emphasis on pragmatic design signals an interest in trials that reflect routine clinical care as much as possible, potentially using streamlined procedures, broadly representative participants, and clinically meaningful endpoints that can support decision-making in real practice settings. Trials can be conducted in inpatient and/or outpatient environments, which allows applicants to target interventions relevant to hospital care, ambulatory management, or transitions between settings. The studies are meant to test the efficacy or real-world effectiveness of promising new therapies or existing therapies being applied in new ways, with an overall goal of generating actionable evidence for chronic lung disease management.

The eligible disease areas are adult chronic pulmonary diseases, with examples explicitly including interstitial lung disease (ILD), pulmonary hypertension (PH), chronic obstructive pulmonary disease (COPD), sarcoidosis, and obstructive sleep apnea. At the same time, the FOA clearly draws boundaries: it excludes asthma, and it excludes acute lung injury and critical care topics. So the target space is chronic, adult pulmonary conditions outside those excluded categories, and applicants are expected to align their proposed trial to that scope.

Within the PTC structure, the PLG funded under this FOA is expected to take primary responsibility for developing the clinical protocol and supporting a designated Lead Investigator through trial conduct and analysis. In other words, awardees are not simply contributing sites; they are leadership entities responsible for the intellectual and operational direction of the specific trial they propose. Because the PTC is meant to host multiple trials, a PLG must also be prepared to operate within a networked environment where coordination with NIH and with the network management core is part of the award expectations.

Administratively, this opportunity is a discretionary NIH program using the cooperative agreement funding instrument and a health-related activity category. It lists CFDA numbers 93.233 (National Center on Sleep Disorders Research) and 93.838 (Lung Diseases Research), reflecting the respiratory and sleep-related domains the program touches. The announcement indicates no cost sharing or matching requirement. The total estimated funding listed in the source data is $1,000,000 for the FOA, which suggests a limited number of awards and reinforces the idea that each funded application is intended to stand up a complete, multi-site pragmatic trial rather than smaller exploratory projects.

Eligibility is broad and includes many common applicant types: state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), and several designated institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities. Faith-based or community-based organizations and eligible federal agencies are also included. However, the FOA draws a firm line on foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. That means the trial leadership and supported activities must be structured to avoid foreign components and remain domestically based under NIH rules.

In terms of timing, the FOA was posted on August 14, 2014, with an original and current closing date of October 20, 2014, and it was archived November 20, 2014. While those dates indicate the specific announcement cycle has passed, the description still captures the model NIH was implementing: a cooperative network designed to efficiently run multiple pragmatic, multi-site adult chronic pulmonary trials, with PLGs leading individual protocols and a separate centralized core (NEMO) managing network operations.

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Previous opportunity: Network Management Core (NEMO) for the Pulmonary Trials Cooperative (PTC) (U01)

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