Pulmonary Trials Cooperative

In 2014, the National Institutes of Health (NIH) issued a pair of funding opportunity announcements for applications to create the Pulmonary Trials Cooperative (PTC). https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-15-015.html and https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-15-016.html. One announcement called for U01 applications to serve as the Protocol Leadership Group (PLG) and the other announcement called for a Network Management Core (NEMO) to serve as the clinical coordinating body for the PTC. The PTC was designed to conduct multiple simple, pragmatic Phase II and III studies to evaluate the potential benefits of new and existing treatment strategies. The primary responsibility of the NEMO, which is coordinated by investigators at the University of Pittsburgh, is to facilitate the trials conducted by the PTC. The primary responsibility of the PLGs is to develop a protocol and provide the necessary resources to support the conduct and data analyses for that project. The NEMO recruits and activates a number of clinical sites to identify and enroll patients depending on the study protocol. In general, the role of the clinical sites is to enroll participants, deliver the study intervention, complete study visits (in-person and phone calls), conduct procedures as defined in the study protocol, aid in data interpretation and participate in manuscript generation. Currently, the PTC is conducting four randomized controlled trials – three in patients with chronic obstructive pulmonary disease [INSIGHT-COPD ({"type":"clinical-trial","attrs":{"text":"NCT02634268","term_id":"NCT02634268"}}NCT02634268), LEEP ({"type":"clinical-trial","attrs":{"text":"NCT02696564","term_id":"NCT02696564"}}NCT02696564), and RETHINC ({"type":"clinical-trial","attrs":{"text":"NCT02867761","term_id":"NCT02867761"}}NCT02867761)] and one in patients with IPF, CleanUP-IPF (http://www.pulmonarytrials.org/). The CleanUP-IPF PLG is led by investigators from Weill Cornell Medicine, University of Virginia, and the Duke Clinical Research Institute.