Some cancer physicians say that the requirements to get patients into trials are too onerous and that the criteria should be relaxed, Nature reports.
It adds that a meeting is to take place this month between Food and Drug Administration officials and stakeholders to determine whether inclusion criteria prevent patients from getting experimental therapies. Nature notes that the requirements are in place to protect patients or the study. For instance, it says patients with liver issues are barred from drug studies that might affect it, but that that restriction was added when cancer drugs had broader toxicity and easing it might be important as the population ages.
Edward Kim, an oncologist at Atrium Health in North Carolina, says broadening requirements could make study populations better reflect the patient population. He and others from FDA, the American Society of Clinical Oncology, and the Friends of Cancer Research published a paper in the fall in the Journal of Clinical Oncology that outlined five criteria they thought could be eased: organ function, minimum age, HIV status, brain metastases, and prior and current malignancies.
“These patients have these characteristics and they’re going to be treated eventually by their doctors,” he tells Nature. “This is the real world.”