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Lung Cancer Clinical Trial Eligibility and Requirements

Based upon a recent retrospective study published in the Journal of Thoracic Oncology, researchers concluded that eligibility and requirements to enroll in lung cancer–related trials have continued to increase in number and complexity. This assessment tends to affirm the reason why only 2% of patients in the United States participate in clinical trials.

“Medical therapy lung cancer trials are becoming more complex, with growing numbers of eligibility criteria and screening procedures,” stated study lead author David E. Gerber, MD, of the Harold C. Simmons Cancer Center, The University of Texas Southwestern Medical Center, in an interview. “The increase in eligibility criteria appears to reflect contemporary practice of adding new criteria relevant to newer treatments such as immunotherapy and targeted therapies without removing criteria not pertinent to these interventions.”

A total of 74 lung cancer clinical trials were identified. Medical therapy trials that centered on targeted or immunotherapeutic agents had an increase in eligibility criteria that went from 17 in 1986 to 1995 to 28 in 2006 to 2016. There was no significant change in eligibility criteria for surgery or radiation therapy trials.

In conclusion, Dr. Gerber noted: “This trend may hinder patient accrual, decrease study completion rates, limit generalizability, and increase costs.”