On August 27, 2020 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported the launch of new longitudinal study in collaboration with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) titled Understanding the lung cancer Patient ExperiEnce in the Real-world setting (Project PEER) (Press release, LUNGevity Foundation, AUG 27, 2020, View Source [SID1234564120]). The overarching goal of Project PEER is to understand the lung cancer patient experience, irrespective of diagnosis (stage/histology), outside of the clinical trial setting.

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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 compare those patterns to what is seen in clinical trial data within the same patient population.

LUNGevity and the FDA have signed a multi-year Research Collaboration Agreement to work together on Project PEER. FDA OCE investigators will have the opportunity through the collaboration to understand different aspects of patient experience (e.g., impact of a diagnosis on physical role-functioning, emotional well-being) in a real-world setting using standardized patient-reported outcome (PRO) instruments commonly used in cancer clinical trials. De-identified data collected through Project PEER will be available to FDA-CDER investigators as well as third-party investigators free of charge. The data collected is not meant for registrational purposes and is meant to be exploratory and hypothesis-generating only.

"In the last 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," says Dr. Upal Basu Roy, PhD, MPH, Vice President of Research at LUNGevity and project lead of Project PEER at LUNGevity. "However, reasons for treatment discontinuation (adverse events, progression, mechanisms of resistance, etc.) 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."

The project will be using the EmpiraMed PRO Portal Software Platform that deploys 100% site-less virtual studies to better evaluate patient experience in the real world. The EmpiraMed PRO Portal will be used to allow study participants to participate in Project PEER more easily while compensating them for their data and time in an engaging manner.

"LUNGevity is proud to collaborate with the FDA to better understand the lung cancer patient experience," says Andrea Ferris, President and CEO of LUNGevity. "Project PEER provides the Agency real-world data about how our patient population, particularly those underrepresented in clinical trials, respond to therapies. Our collaboration with the FDA has the potential to make an impact on the future of treatment for lung cancer, resulting in better outcomes for patients."

"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. "We are pleased to collaborate with LUNGevity to explore alternative data sources and increase our understanding of the patient experience."

You can find more information on Project PEER at the study website: View Source

Project PEER is an international study and open to any adult participant with lung cancer or caregiver who is able to read and respond to questions in English. There is no limit on the number of participants or countries included in Project PEER. LUNGevity hopes to enroll around 1,200 patients and 300 caregivers.