Pitt investigators to lead $15 million federal initiative to manage breathing disorder clinical trials

The University of Pittsburgh Graduate School of Public Health and School of Medicine investigators will be leading a $15 million, five-year federal initiative to manage national clinical trials aimed at developing new treatments for breathing disorders. The effort is funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).

The Network Management Core - or NEMO - will coordinate and support trials related to the Pulmonary Trials Cooperative (PTC), which will carry out multiple clinical studies on a variety of chronic lung conditions, including interstitial lung disease, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, sarcoidosis and obstructive sleep apnea.

"The PTC program brings together expertise in lung disease research and treatment across the nation in one single, dynamic enterprise," said Tony Punturieri, M.D., Ph.D., program officer in the Division of Lung Diseases at NHLBI. "This novel structure should facilitate efforts to get tested clinical care to patients in dire need of new treatments across a broad spectrum of lung diseases."

Chronic lung diseases are some of the most common medical conditions in the world, with more than 15 million people in the U.S. suffering from COPD alone, a condition which is the third-leading cause of death nationwide, according to the American Lung Association.

The NEMO will be led by Stephen Wisniewski, Ph.D., epidemiology professor in Pitt Public Health, and Frank Sciurba, M.D., director of Pitt's Emphysema COPD Research Center in the Division of Pulmonary, Allergy and Critical Care Medicine.

"Across the country, multiple clinical trials will be in operation to address the urgent need for new treatments and to test existing treatments for people with chronic lung conditions, all managed under one program," said Dr. Wisniewski, also Pitt's associate vice provost for planning. "This will create a massive amount of data and requires diligent coordination and collaboration among trial sites, which we at Pitt have extensive experience facilitating."

"Investigators in our pulmonary division have offered leadership in many clinical trials over the years and have successfully translated the latest scientific findings into improved patient care," said Dr. Sciurba, also an associate professor in Pitt's School of Medicine. "This expertise will be a great asset as we recruit and organize several dozen medical centers to work together to test new treatments for pulmonary patients."

The PTC has letters of support from over 100 clinical research programs nationwide with registries totaling 72,000 people.

Through the NEMO, Pitt will recruit and manage the clinical centers that will carry out specific trials awarded separately by NHLBI with cooperative agreement grant mechanisms. To improve efficiency and expedite the trials, the NEMO will develop and distribute study-specific manuals, train staff at the clinical centers, manage a bank of biospecimens, provide a secure Web portal for communication among researchers and coordinate meetings, among many other responsibilities.