Edward S. Kim, MD, chair, Department of Solid Tumor Oncology, Levine Cancer Institute, discusses clinical trial eligibility criteria in lung cancer.
Kim led a task force that evaluated the impact of eligibility criteria on clinical trial enrollment and found that if there were less than 27 eligibility criteria, the trial had a higher likelihood of enrolling faster. Since then, ASCO teamed up with Friends of Cancer Research to expand on this work. Kim led the effort to see which eligibility criteria were truly necessary. A minimum age of 18 and HIV negativity serve as current criteria, but they shouldn’t be, says Kim. Additional criteria that were evaluated included the presence of brain metastases and organ function like creatinine clearance and liver enzymes. Instead of barring these patients from clinical trials because it’s been copied and pasted over from the previous protocol, the field should find clinical reasons why these patients should not be eligible to enroll on specific trials.
This research was published in the Journal of Clinical Oncology in October 2017. As a result, the Cancer Therapy Evaluation Program revised their protocol templates in 2018, and the FDA issued guidance documents in 2019. Moreover, cooperative groups have endorsed this notion as well. The last step will be to get industry on board, concludes Kim.