FDA unveils 5 guidances on broadening cancer clinical trial eligibility
As part of a push to transform clinical trial eligibility criteria that have been accepted over time without a clear scientific or clinical rationale, the FDA on Tuesday published four draft guidance documents on cancer clinical trial eligibility criteria and one final guidance on including adolescents in adult oncology trials.
The four drafts, developed by the FDA with input from the American Society of Clinical Oncology and Friends of Cancer Research, focus on minimum age for pediatric patients; patients with HIV, hepatitis B or C viruses; patients with organ dysfunction or prior or current malignancies; and patients with brain metastases.
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