Cancer Drug Trials Could Benefit From ‘Rational’ Eligibility Criteria
US FDA drug reviewers argue that enrolling more heterogeneous patient populations could result in fewer postmarketing requirements and earlier satisfaction of pediatric study obligations.
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ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men
Exploratory analysis suggests cancer patients with poorer baseline status can be enrolled in clinical trials without endangering registration prospects for the drug. Older prostate cancer patients derived a similar benefit to younger patients in metastasis-free survival with androgen-receptor inhibitors, FDA researchers found in an exploratory subgroup analysis of three registrational trials.
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Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is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.