Cancer Trials: Broader Eligibility Criteria Could Mean Novel Labeling Claims
Enrolling patients with stable brain metastases, HIV-positive status and other traditionally excluded groups could give sponsors a marketing edge, but trials should be designed to examine drug effects on such populations separately from the more traditional study population, stakeholders said.
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Oncology Clinical Trial Eligibility Expansion A Focus For US FDA; Sponsors Overcoming Initial Hesitation
US FDA plans to release a second set of guidances to industry; sponsors caution that tradeoffs need to be clear from onset.
Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.
Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is coming soon on master protocols, adaptive designs and novel endpoints, FDA's Gottlieb says.