Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs
US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.
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US FDA’s ‘Project Optimus’ Will Encourage Move Away From Conventional Dose-Finding For Modern Cancer Therapies
Simply carrying forward the maximum tolerated dose into later-stage trials does not account for the importance of long-term tolerability – and the fact that higher doses are not necessarily better for patients.
“Breakthrough” Dose-Finding In Oncology
The “Breakthrough” era in oncology drug development creates new stress points in the effort to accelerate time-to-market. One important one involves the age-old challenge of finding the right dose – particularly in an era when the old idea of pushing the dose no longer makes sense.
Medicare Price Negotiations: Competitors’ Net Prices, Clinical Benefit Are ‘Starting Point’ For Initial Offer
CMS chose the prices of therapeutic alternatives and these competitors’ comparative benefits as the ‘foundation and starting point’ for setting an initial offer for drugs subject to negotiation, ahead of other factors Congress laid out it could consider that are more singularly focused on the specific drug at issue.