Cancer Trials: Broader Eligibility Criteria Could Mean Novel Labeling Claims

06 Dec 2016

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.

Broadening the eligibility criteria for cancer clinical trials could enable sponsors to pursue novel labeling claims that help differentiate their products on the market.

However, sponsors must take care in how they design studies to incorporate populations that traditionally have been excluded from cancer...