Cancer Clinical Trials My Papers Pharmaceuticals Regulation

Should the FDA speed up or slow down approval of new cancer drugs?

That is the title of my recent piece in STAT News.

Earlier this month, the Food and Drug Administration announced the creation of Project Facilitate. This pilot program facilitates access to innovative treatments for cancer that have not yet been approved by individuals who aren’t able to enroll in clinical trials. This move suggests that the FDA finds the approval process for cancer drugs to be too slow…

Is the FDA correct in its approach? Research I have done with various colleagues argues that if you believe in patient-centered care, the FDA is indeed doing the right thing.

The rest of the article describes how my research can explain differences in patient and physician risk preferences, evidence on how much credibility we should give clinical trials with surrogate outcomes, and quantifying the cost of delaying approvals of new cancer drugs.

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