Many studies are now more inclusive, thanks to the work of experts at UT Southwestern.
Clinical trials in the U.S. struggle to enroll patients. Fewer than 5% of adults with cancer in the U.S. enroll in clinical trials, and a substantial proportion of clinical trials close before they finish because they are unable to meet accrual targets or, because it takes so long to meet the accrual numbers, the study is no longer relevant. [1,2] On top of that, a general criticism of clinical trials is that their eligibility criteria are so selective that the results are not generalizable to real-world patients.
Under this pretext, I grew increasingly frustrated that a number of my patients who came to see me for lung cancer clinical trials were not eligible because they had a history of an earlier cancer, and this often was the only reason they were ineligible. The referring physicians shared this frustration, and it was especially so for the patients because they didn’t understand why a prior cancer should prevent them from participating in a study.
I began to wonder: (1) How common is this practice? (2) How does this practice affect enrollment in clinical trials? and (3) Is this practice justified? In other words, what proportion of lung cancer clinical trials exclude patients with a prior cancer? How common is a prior cancer diagnosis among patients with lung cancer? And do lung cancer patients who had an earlier cancer have worse outcomes than patients who did not have a prior cancer?
These questions led me to reach out to other experts, including health outcomes expert Ethan Halm, M.D., M.P.H., Professor of Internal Medicine and Population and Data Sciences, epidemiologist Sandi Pruitt, Ph.D., Associate Professor of Population and Data Sciences, and statistician Lei Xuan, Ph.D.