Clinical Trial Eligibility Criteria: Barriers for People With Lung Cancer
A retrospective study of lung cancer clinical trials found that trials continue to increase their eligibility criteria, creating barriers to patient access.
The number of eligibility criteria required by clinical trials for lung cancer continues to increase, according to a study published in The Journal of Thoracic Oncology.
Screening and eligibility criteria are implemented to maximize trial efficiency and patient safety, but they also impact other factors critical to clinical trials such as enrollment, complexity, and cost.
For this retrospective study, investigators identified and compiled data from 74 lung cancer clinical trials conducted from 1986 to 2016. Trials were stratified to 3 groups by the years in which they were conducted: 1986-1995, 1996-2005, and 2006-2016.
Results of the study demonstrated that the number of eligibility criteria significantly increased over time for medical trials only. Median eligibility criteria was 16 in 1986-1995 compared with 19 in 1996-2005 (P =.05), and increased again to 27 in 2006-2017 (P <.001).
Surgery and radiation therapy trials sustained stable numbers of eligibility criteria over time.
Trials assessing cardiac, concurrent medication, gastrointestinal, hematologic, hepatic, inflammatory, neurologic, renal, or prior cancer therapy had significant increases in eligibility criteria (P <.05), but increases were not observed in pulmonary and endocrine categories.
The total number of eligibility criteria was also correlated with the principal therapy assessed by the trial (median 9 for surgical procedures, 18 for radiation, 20 for medical; P =.02), trial primary end point (median 20 for overall survival, 28 for progression-free survival, 17 for others; P =.001), and number of therapies (P =.05).
Although there was a significant increase in the number of required blood tests (median 11 in 1986-1995, 15 in 1996-2005, 19 in 2006-2016; P =.006), other screening requirements did not have any significant increases, or decreased over time.
The investigators conclude saying “with federal funding for cancer clinical trials decreasing and substantial proportion of NCI-sponsored cancer clinical trials not completing accrual, ongoing efforts to simplify eligibility and procedures will be critical moving forward.”
Garcia S, Bisen A, Yan J, et al. Thoracic oncology clinical trial eligibility criteria and requirements continue to increase in number and complexity [published online August 9, 2017]. J Thorac Oncol. doi: 10.1016/j.jtho.2017.07.020