Tag: adaptive clinical trials

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Clinical trials Medicine Politics Popular culture Skepticism/critical thinking

The 21st Century Cures Act: Old vinegary wine in a new bottle

The 21st Century Cures Act: Familiar old promises that we'll have all sorts of new cures if only the FDA would stop being so pesky about requiring rigorous evidence of efficacy and safety before approving a drug.

The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces […]

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Cancer Clinical trials Medicine Science

Clinical trials do still work, but need to evolve

As I write this, I’m winging my way home from TAM, crammed uncomfortably—very uncomfortably—in a window seat in steerage—I mean, coach). I had thought of simply recounting the adventures of the contingent of skeptics with whom I’m associated who did make it out to TAM to give talks at workshops and the main stage and […]