DENVER -Eligibility criteria continue to increase in number and complexity for lung cancer clinical trials.
Cancer clinical trials have complex requirements for design, study, and eligibility criteria that often act as a barrier to the development of new clinical trials as well as patient enrollment. With the advent of molecular targeted therapies and immunotherapy, requirement criteria have continued to increase in number and complexity. Despite calls to streamline cancer clinical trial processes and efforts to improve cancer clinical trial patient accrual, completion rates and generalizability, fewer than two percent of adults with cancer in the United States participate in clinical trials.
A group of investigators in the United States conducted a retrospective study to evaluate contemporary trends in cancer clinical trial inclusiveness and complexity. The group quantified and categorized eligibility criteria in lung cancer clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group (ECOG) Thoracic Committee from 1986 through 2016. Associations between clinical trial characteristics and eligibility criteria were analyzed by nonparametric statistical methods, such as the Wilcoxon two-sample test and the Kruskal-Wallis test.
The results of the study were published in the Journal of Thoracic Oncology, the official journal of the International Association for the Study of Lung Cancer (IASLC) . A total of 74 lung cancer clinical trials sponsored or endorsed by the ECOG Thoracic Committee with full study protocols were identified. Medical therapy trials (targeted therapy and immunotherapy) had an increase in eligibility criteria over time from 17 in 1986-1995 to 28 in 2006-2016 (p<0.001), whereas there was no significant change in eligibility criteria…