View all available purchase options and get full access to this article. Published in print: February 01, 1997 Published online: September 21, 2016 Request permissions for this article. Critical role of phase I clinical trials in cancer treatment. American Society of Clinical Oncology.. JCO 15, 853-9 (1997). DOI: 10.1200/JCO.1997.15.2.853 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility