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.
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.
Many of US FDA's outside vaccine advisors wanted to wait for more data before widespread inoculations of kids 5-11, but felt some high-risk populations should get access to vaccine right away. They urged CDC to provide additional guidance on which children should be targeted.