Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity

Abstract

Background Eligibility criteria and screening procedures are designed to optimize the scientific yield and maximize the safety of clinical trials. However, they may also heighten trial complexity, hinder enrollment, decrease generalizability, and increase costs. We analyzed the types and number of eligibility criteria and screening procedures among thoracic oncology clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group (ECOG). Methods We identified trials and obtained protocols from the ECOG website. Eligibility criteria were grouped and categorized as comorbidity (classified by organ system), administrative requirements, prior treatment, and measurable disease requirement. Associations between trial characteristics and eligibility criteria were analyzed using Kruskal-Wallis and Wilcoxon tests. Results A total of 74 lung cancer trials activated 1986–2016 were identified. The total number of eligibility criteria was associated with trial principal therapy (median 9 for surgical, 18 for radiation, 20 for medical; P=0.02), trial primary endpoint (median 20 for OS, 28 for PFS, 17 for other; P=0.001), number of therapies (P=0.05), and year of activation (median 16 for 1986–1995, 19 for 1996–2005, 27 for 2006–2016; P<0.001). The increase in trial eligibility requirements over time was limited to medical therapy trials. Over time, there was also an increase in blood test screening procedures (P=0.05), but not for imaging, cardiac assessment, or pulmonary function screening procedures. Conclusions The number of eligibility criteria and screening procedures in medical therapy lung cancer clinical trials continues to rise. Continued efforts to simplify protocol eligibility and procedures are warranted to promote trial adherence, enrollment, completion, and generalizability.

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“…Adequate procedures, such as interpreting and periodically summarising the available information, should be evaluated. ECRO will employ the following methods to attain its objectives (box 1): 12 ; the occurrence and causes of excessive delays in starting treatment in cancer patients due to centralised molecular testing [13][14][15] ; the broadening of eligibility inclusion criteria in clinical trials, to avoid disparities in care [16][17][18] ; the consequences of outsourcing the monitoring of trials 7 ; the need to simplify informed consents 11 and so on. 3.…”

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