Dr. David Gerber, University of Texas Southwestern, and LUNGevity Foundation Publish Recommendations to Simplify and Harmonize Lung Cancer Clinical Trials

Paper offers framework for standardizing eligibility criteria for lung cancer clinical trials

WASHINGTON, Aug. 30, 2022 /PRNewswire/ -- LUNGevity Foundation, the nation's leading lung cancer-focused nonprofit organization, convened a team of oncology thought leaders, the United States Food and Drug Administration, the National Cancer Institute, and industry sponsors to develop recommendations for a framework for lung cancer clinical trial eligibility criteria. The eligibility template recommendations, published recently in JAMA Oncology, will help simplify eligibility criteria and make searching for and comparing clinical trials easier for patients and clinicians.

Since 2016, LUNGevity Foundation has been convening a multi-stakeholder working group of researchers, regulators, and policymakers from the US Food and Drug Administration (FDA), National Cancer Institute, and leading cancer institutions as part of the Foundation's Scientific and Clinical Research Roundtable to streamline lung cancer clinical trials and make them more accessible to patients. The eligibility template recommendations discussed in the article build on previously developed eligibility criteria developed by the National Cancer Institute, American Society of Clinical Oncology, and Friends of Cancer Research as well as previous LUNGevity work, and received feedback from international regulatory authorities, clinicians, and industry sponsors.

Currently, clinical trial eligibility criteria are not listed in a consistent, uniform manner, which makes searching on public websites, such as clinicaltrials.gov, difficult for patients. "When patients are looking for a clinical trial to consider participating in, the eligibility criteria are often confusing and difficult to navigate. Additionally, eligibility criteria can be inconsistent across trials, making it difficult to compare data and results for a researcher. There is also a tendency for researchers to 'copy and paste' restrictive criteria from previous protocols, potentially excluding patients who could otherwise participate," said David Gerber, MD, of UT Southwestern Medical Center, lead author of the paper. "Given all of these challenges, we wanted to find a way to prioritize eligibility criteria for lung cancer clinical trials and recommend standardized language that can improve consistency across the research community."

The recommendations are expected to make it easier to for patients to search for clinical trials on public websites and help researchers compare criteria across trials, and suggest that: 

• Eligibility categories should be clearly laid out on public websites displaying clinical trials in an easily searchable format and in a specific priority order.
  
  
• Criteria should incorporate recommended language, and any deviation from the recommended eligibility criterion language should be explained

"LUNGevity's Scientific and Clinical Research Roundtables aim to make clinical trials more patient-centric and accessible, so that all patients have an opportunity to engage with and benefit from clinical trials," said Upal Basu Roy, PhD, MPH, Executive Director of LUNGevity Research and another author of the paper. "Through previous publications, the Foundation has advocated for expanding eligibility criteria and removing restrictive eligibility in lung cancer clinical trials to increase the number of patients able to access livesaving therapies in clinical development. This manuscript is the culmination of a body of work around eligibility criteria that LUNGevity has been spearheading, and we are eager to review the DRAFT guidance that is expected from the US FDA later this year."

Other authors of the paper are Harpreet Singh, MD, and Erin Larkins, MD, of the FDA; LUNGevity Scientific Advisory Board member Patrick M. Forde, MD, of Johns Hopkins University; Andrea Ferris of LUNGevity Foundation; and Wendy Selig of WSCollaborative LLC.

LUNGevity Foundation is the nation's leading lung cancer organization focused on improving outcomes for people with lung cancer. The foundation works tirelessly to advance research into early detection and more effective treatments, and to ensure that patients have access to these advances. LUNGevity seeks to make an immediate impact on quality of life and survivorship for everyone touched by the disease—while promoting health equity by addressing disparities throughout the care continuum. LUNGevity provides information and educational tools to empower patients and their caregivers, promote impactful public policy initiatives, and amplify the patient voice through research and engagement. The organization provides an active community for patients and survivors—and those who help them live better and longer lives.

Comprehensive resources include a medically vetted and patient-centric website, a toll-free HELPLine for support, the International Lung Cancer Survivorship Conference, and an easy-to-use Clinical Trial Finder, among other tools. All of these programs are to achieve our vision—a world where no one dies of lung cancer. LUNGevity Foundation is proud to be a four-star Charity Navigator organization.

• About 1 in 17 Americans will be diagnosed with lung cancer in their lifetime.
• More than 236,000 people in the US will be diagnosed with lung cancer this year.
• About 60%-65% of all new lung cancer diagnoses are among people who have never smoked or are former smokers.
• Lung cancer takes more lives in the United States than the next two deadliest cancers (colorectal and pancreatic) combined.
• Only about 23% of all people diagnosed with lung cancer in the United States will survive 5 years or more, BUT if it is caught before it spreads, the chance of 5-year survival improves dramatically.

Please visit LUNGevity.org to learn more.

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SOURCE LUNGevity Foundation