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Clinical trial sponsors rely on eligibility criteria to control the characteristics of patients in their studies, promote the safety of participants, and optimize the interpretation of results. However, in recent years, complex and often overly restrictive inclusion and exclusion criteria have created substantial barriers to patient access to novel therapies, hindered trial recruitment and completion, and limited generalizability of trial results. A LUNGevity Foundation working group developed a framework for lung cancer clinical trial eligibility criteria. The goals of this framework are to (1) simplify eligibility criteria, (2) facilitate stakeholders’ (patients, clinicians, and sponsors) search for appropriate trials, and (3) harmonize trial populations to support intertrial comparisons of treatment effects.
Clinicians and representatives from the pharmaceutical industry, the National Cancer Institute, the US Food and Drug Administration (FDA), the European Medicines Agency, and the LUNGevity Foundation undertook a process to identify and prioritize key items for inclusion in trial eligibility criteria. The group generated a prioritized library of terms to guide investigators and sponsors in the design of first-line, advanced non–small cell lung cancer clinical trials intended to support marketing application. These recommendations address disease stage and histologic features, enrollment biomarkers, performance status, organ function, brain metastases, and comorbidities. This effort forms the basis for a forthcoming FDA draft guidance for industry.
Conclusions and Relevance
As an initial step, the recommended cross-trial standardization of eligibility criteria may harmonize trial populations. Going forward, by connecting diverse stakeholders and providing formal opportunity for public input, the emerging FDA draft guidance may also provide an opportunity to revise and simplify long-standing approaches to trial eligibility. This work serves as a prototype for similar efforts now underway for other cancers.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: December 13, 2021.
Published Online: August 4, 2022. doi:10.1001/jamaoncol.2022.1664
Corresponding Author: David E. Gerber, MD, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Mail Code 8852, Dallas, TX 75390-8852 (firstname.lastname@example.org).
Author Contributions: Dr Gerber had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Gerber, Singh, Ferris, Forde, Selig, Basu Roy.
Acquisition, analysis, or interpretation of data: Gerber, Larkins, Ferris, Forde, Basu Roy.
Drafting of the manuscript: Gerber, Forde, Selig, Basu Roy.
Critical revision of the manuscript for important intellectual content: All authors.
Administrative, technical, or material support: Gerber, Ferris, Selig, Basu Roy.
Supervision: Gerber, Ferris, Forde, Selig.
Conflict of Interest Disclosures: Dr Gerber reported nonfinancial support from Sagimet Biosciences; grants from Karyopharm and AstraZeneca; personal fees from Janssen, Sanofi, Regeneron, and Catalyst; and stock ownership in Gilead Sciences outside the submitted work. Dr Forde reported personal fees from Amgen, AstraZeneca, Janssen, Bristol Myers Squibb, Kyowa, Daiichi Sankyo, Genentech, iTeos, and Sanofi, as well as grants from Corvus outside the submitted work. Ms Selig reported personal fees from the LUNGevity Foundation during the conduct of the study as well as personal fees from Pfizer, Daiichi Sankyo, TriSalus Life Sciences, and Cytokinetics outside the submitted work. Dr Basu Roy reported grants from Boehringer Ingelheim, Takeda, Genentech, Janssen, Amgen, Bristol Myers Squibb, Merck, Blueprint Medicine, G1 Therapeutics, Jazz Pharmaceuticals, Eli Lilly, and AstraZeneca, as well as personal fees from AstraZeneca and serving as a noncompensated board member for ROS1ders outside the submitted work. No other disclosures were reported.
Additional Contributions: We thank Gisele Sarosy, MD, Andrea Denicoff, RN, MS, ANP, Shakuntala Malik, MD, and Sheila Prindiville, MD, MPH, from the National Cancer Institute for their participation in the working group and feedback on the development of the template, as well as See Phan, MD, and Barbara Gitlitz, MD (Genentech), Nabil Chehab, PhD, MBA (AstraZeneca), and Troy Sarich, PhD (Janssen), for their feedback on the eligibility template. There was no compensation provided for these contributions.
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