TY - JOUR
T1 - Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity
AU - Garcia, Sandra
AU - Bisen, Ajit
AU - Yan, Jingsheng
AU - Xie, Xian Jin
AU - Ramalingam, Suresh
AU - Schiller, Joan H.
AU - Johnson, David H.
AU - Gerber, David E.
N1 - Funding Information:
This study was funded in part by the University of Texas Southwestern Medical Student Summer Research Program (to Ms. Garcia), a National Cancer Institute (NCI) Midcareer Investigator Award in Patient-Oriented Research ( K24CA201543-01 [to Dr. Gerber]), and a NCI National Clinical Trials Network Lead Academic Site Award (5U10CA180870-02 [to Dr. Gerber]). Biostatistical support was provided by the Biostatistics and Bioinformatics Shared Resource at the Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, which is supported in part by a NCI Cancer Center Support Grant, 1P30 CA142543-03. Research reported in this publication was also supported by the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) under award TL1TR001104 and Clinical and Translational Science Awards NIH Grant UL1-RR024982. The contents of this study are solely the responsibility of the authors and do not necessarily represent the official views of the NCI. For their assistance obtaining clinical trial protocols, the authors thank BilliSue Sawyer, Laura Gagnon, and Elizabeth O'Conner from the Coordinating Center of the Eastern Cooperative Oncology Group (Peter J. O'Dwyer, MD, chair), which is supported in part by Public Health Service Grant CA23318 from the NCI, NIH, and the Department of Health and Human Services. The authors also thank Helen Mayo, MLS, from the University of Texas Southwestern Medical Center Library for her assistance performing literature searches and Ms. Dru Gray for assistance with manuscript preparation.
Publisher Copyright:
© 2017 International Association for the Study of Lung Cancer
PY - 2017/10
Y1 - 2017/10
N2 - Introduction 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. Methods We identified trials and obtained protocols from the Eastern Cooperative Oncology Group website. Eligibility criteria were grouped and categorized as comorbidity (classified by organ system), administrative requirements, prior treatment, and measurable disease requirements. Associations between trial characteristics and eligibility criteria were analyzed by using the Kruskal-Wallis and Wilcoxon tests. Results A total of 74 lung cancer trials activated in 1986–2016 were identified. The total number of eligibility criteria was associated with trial principal therapy (a median of nine for surgical, 18 for radiation, and 20 for medical therapy [p = 0.02]), trial primary end point (a median of 20 for overall survival, 28 for progression-free survival, and 17 for other [p = 0.001]), number of therapies (p = 0.05), and year of activation (a median of 16 for 1986–1995, 19 for 1996–2005, and 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 in 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.
AB - Introduction 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. Methods We identified trials and obtained protocols from the Eastern Cooperative Oncology Group website. Eligibility criteria were grouped and categorized as comorbidity (classified by organ system), administrative requirements, prior treatment, and measurable disease requirements. Associations between trial characteristics and eligibility criteria were analyzed by using the Kruskal-Wallis and Wilcoxon tests. Results A total of 74 lung cancer trials activated in 1986–2016 were identified. The total number of eligibility criteria was associated with trial principal therapy (a median of nine for surgical, 18 for radiation, and 20 for medical therapy [p = 0.02]), trial primary end point (a median of 20 for overall survival, 28 for progression-free survival, and 17 for other [p = 0.001]), number of therapies (p = 0.05), and year of activation (a median of 16 for 1986–1995, 19 for 1996–2005, and 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 in 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.
KW - Accrual
KW - Clinical research
KW - Enrollment
KW - Exclusion criteria
KW - Inclusion criteria
KW - Lung cancer
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U2 - 10.1016/j.jtho.2017.07.020
DO - 10.1016/j.jtho.2017.07.020
M3 - Article
C2 - 28802905
AN - SCOPUS:85029509557
SN - 1556-0864
VL - 12
SP - 1489
EP - 1495
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 10
ER -