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Tag: Precision Medicine

A Rosa Parks Moment is Coming in Phase 1 Cancer Trials

By DAVID C. NORRIS, MD

I want to tell you about the most exciting discovery I’ve made in 2+ years of research on dose individualization methods for phase 1 cancer trials. This discovery has nothing to do with any of the technical problems I’ve confronted and solved along the way. It involves no gigantic equation, no table of simulations results, and no colorful plot. Rather, it’s a discovery about sources of power to innovate in drug development.

In general, how would you describe the balance of power between Big Pharma and the individual patient? The question seems ludicrous—maybe even offensive—in light of ongoing scandals with price-hikes and shortages for critical drugs. But in the special area of trial methodology, I’ve got a real surprise for you…

One result from my DTAT research has been a clear demonstration that 1-size-fits-all dose finding in phase 1 cancer trials can cut the value of a drug in half, or even drop it to zero by setting the drug up for failure in phase 2 or 3. Although this economic argument has never been made quite so explicit and rigorous, I am certain the underlying principle comes as no surprise to anyone. (I note hardly anyone bats an eye when I detail the math.) Continue reading…

Three Recommendations for President Obama’s Precision Medicine Initiative

One of the pleasantly surprising announcements President Obama made during his 2015 State of the Union address was “a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes.”

Given precision medicine’s potential to solve many outstanding health care issues and lower costs without compromising clinical quality and performance, the President’s proposal is a welcome initiative. Many of the challenges we face practicing symptom-focused intuitive medicine could be overcome by turning toward precision medicine, a process of precisely diagnosing and targeting disease.

However, announcing the initiative is one thing. As with all policy discussions, the devil is in the details – and there are three details specifically that could make the difference between political rhetoric and a policy that truly improves the health of American citizens.Continue reading…

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