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.
You may also be interested in...
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.
Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling
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.
Guidance By Guidance, US FDA Is Reshaping The Look Of Cancer Drug Trials
Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is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.