FDA staff call for broader cancer trial eligibility criteria

Richard Pazdur, director of FDA's Oncology Center of Excellence, called for rational approaches to broadening clinical trial eligibility criteria, including enrolling patients aged under 18 in adult trials, to improve cancer studies by capturing the heterogeneity of patient populations that would use therapies after they are approved. The comments were published Thursday in a The New England Journal of Medicine perspective, co-authored by Julia Beaver and Gwynn Ison of FDA's Center for Drug Evaluation and Research.

The article called out "unnecessarily restrictive" trial enrollment criteria, including the exclusion of patients from oncology trials if they have had prior cancers. The authors argued that rational steps could be taken to broaden criteria without endangering patients or compromising results, such as enrolling patients whose prior cancers have low potential for recurrence. ...