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LUNGevity, FDA Launch Lung Cancer Patient Research Project


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LUNGevity Foundation, a nonprofit organization focused on lung cancer, recently announced the launch of a new longitudinal study in collaboration with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. The project, understanding the lung cancer patient experience in the real-world setting (Project PEER), is focused on comprehending the experiences of patients with lung cancer at all stages and histologies outside of the clinical trial setting.

About Project PEER

The Project PEER collaboration seeks to systematically understand how patients with lung cancer feel and function and whether this experience is affected by their specific diagnosis and treatment. The real-world data from Project PEER will be used to explore patterns in patient experiences and to compare those patterns with what is seen in clinical trial data within the same patient population.

Investigators from the FDA’s Oncology Center of Excellence will have the opportunity through the collaboration to understand the impact of a lung cancer diagnosis on physical role-functioning, emotional well-being, and other aspects of the patient experience in a real-world setting. The group will use standardized patient-­reported outcome instruments; de-identified data will be collected through Project PEER and made available to the FDA’s Center for Drug Evaluation and Research investigators as well as third-party investigators at no cost.

“In the past few years, science has progressed at an unprecedented rate as new categories of therapies have become available and the application of existing therapies has expanded,” said Upal Basu Roy, PhD, MPH, Vice President of Research at LUNGevity and project lead of Project PEER at LUNGevity. “However, reasons for treatment discontinuation … are not well documented beyond a clinical trial context. Similarly, how patients experience their disease in terms of symptoms, impacts, outcomes, and quality of life throughout their disease progression is unclear. We are excited to launch this study to better understand these issues and, ultimately, help provide the best care possible to the lung cancer community.”

Upal Basu Roy, PhD, MPH

Upal Basu Roy, PhD, MPH

Andrea Ferris

Andrea Ferris

Paul Kluetz, MD

Paul Kluetz, MD

“LUNGevity is proud to collaborate with the FDA to better understand the lung cancer patient experience,” said Andrea Ferris, President and Chief Executive Officer of LUNGevity. “Project PEER provides the agency real-world data about how our patient population, particularly those underrepresented in clinical trials, respond to therapies.”

“Characterizing how patients with lung cancer experience treatment in the real-world setting is an important opportunity to improve our understanding of cancer therapy,” said Paul Kluetz, MD, Deputy Director of the FDA’s Oncology Center of Excellence.

More information is available at studylc2.empiramed.org/pub/study/lc2.

 


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