Patients with incurable cancers should have an easier time getting into clinical trials under new FDA guidance on developing criteria for trial eligibility.
The final guidance marks the latest effort by the Food and Drug Administration to expand the criteria for who can participate in cancer studies. Enrollment has remained an ongoing challenge in oncology research and drug development—a problem that’s only exacerbated by health disparities.
“Particularly for patients with advanced cancers, clinical trials present an important opportunity to receive potentially groundbreaking treatments and optimized care,” Jeff Allen, president and CEO of Friends of Cancer Research, said.
“This latest guidance from the FDA lays out additional ways in which eligibility criteria can be expanded to enable patient access to such trials earlier in the course of their treatment,” he said.
Julie R. Gralow, executive vice president and chief medical officer of the American Society of Clinical Oncology, said the guidance represents a critical step in moving towards equity in clinical trial access. It will provide “potentially life-saving options for patients who may otherwise have limited access to treatments.”
Expanded criteria should be combined with additional risk-benefit assessment “to ensure optimal patient-clinician decision-making and informed consent,” Gralow added.
The guidance offers recommendations for enrolling patients who have a tumor that can’t be removed, or leukemia, lymphoma, or multiple myeloma with a low chance of long-term survival.
The latest document finalizes a draft issued in June. The FDA said Tuesday in a Federal Register notice that it includes additional recommendations on how to evaluate safety in early stage studies to figure out what the proper dose is.
Companies and investigators often transfer eligibility criteria from study to study. Friends and the American Society of Clinical Oncology have advocated for expanding clinical trials by better tailoring who can participate to the study at hand.
Over the past five years, FDA has issued guidance to expand criteria to patients who have been historically left out, such as HIV patients and those whose cancers have spread.
ASCO and Friends will continue to work with the FDA and other stakeholders to broaden eligibility criteria for cancer clinical trials, Gralow said.
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