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PS01.02: Thoracic Oncology Clinical Trial Eligibility Criteria: Ongoing Increase in Recent Years
Conference poster   Open access   Peer reviewed

PS01.02: Thoracic Oncology Clinical Trial Eligibility Criteria: Ongoing Increase in Recent Years

David Gerber, Sandra Garcia, Jingsheng Yan, Xian-Jin Xie, Suresh Ramalingam, Joan Schiller and David H Johnson
Journal of Thoracic Oncology, Vol.11(11 S), pp.S270-S271
IASLC 2016 Chicago Multidisciplinary Symposium in Thoracic Oncology (Chicago, IL, 09/22/2016–09/24/2016)
2016
DOI: 10.1016/j.jtho.2016.09.038
PMID: 27969469
url
https://doi.org/10.1016/j.jtho.2016.09.038View
Abstract of Poster Session Open Access

Abstract

<p>Background: Eligibility criteria are designed to optimize the scientific yield and maximize the safety of clinical trials. However, they may also heighten trial complexity,hinder enrollment, and decrease generalizability of results. We analyzed the types and number of eligibility criteria among thoracic oncology clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group (ECOG). </p> <p>Methods: We identified trials and obtained protocols from the ECOG website (www.ecog.org). Trial eligibility criteria were quantified by two investigators (SG, DEG)Journal of Thoracic Oncology Vol. 11 No. 11S: S270-S322 and categorized as comorbidity, administrative requirements, prior treatment, and measurable disease requirement. Comorbidity was further characterized by organ system. Associations between trial characteristics and eligibility criteria were analyzed using Kruskal-Wallis and Wilcoxon tests. </p> <p>Results: A total of 92 thoracic oncology trials activated1986-2016 were identified. Of these, 11 were categorized as surgical, 14 as radiation, 64 as medical, and 3 asother. Trial primary endpoint was overall survival (OS)in 28, progression-free survival (PFS) in 18, and other in46. Trial activation year was as follows: 1986-1999(n¼43), 2000-2009 (n¼30), 2010-2016 (n¼19). Thetotal number of eligibility criteria was associated withtrial principal therapy (median 7 for surgical, 18 for radiation, 20 for medical;P¼0.001), trial primary endpoint (median 20 for OS, 23 for PFS, 15 for other;P<0.001), and year of activation (median 16 for 1986-1999, 19 for 2000-2009, 24 for 2010-2016; P<0.001). Over time, there was a statistically significant increase inthe number of eligibility in the following categories:hepatic, renal, hematologic, gastrointestinal, neurologic, rheumatologic, concurrent medications, prior cancer therapy, and legal. There was no significant change in the number of eligibility criteria in the cardiovascular, pulmonary, endocrine, and administrative categories. </p> <p>Conclusion:Despite calls to simplify trial enrollment processes, the number of eligibility criteria in thoracic oncology clinical trials continues to rise. This increase occurs across a variety of organ comorbidities, as well asconcurrent and prior therapy exposure. Continued attention to the number and nature of eligibility criteriais warranted to promote trial enrollment, completion, and generalizability. </p>

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