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Simply eliminating Phase I is the wrong solution. Entering a Phase II study before Phase I is a great way to maim or kill people. Anti-cancer drugs are often

Simply eliminating Phase I is the wrong solution. Entering a Phase II study before Phase I is a great way to maim or kill people. Anti-cancer drugs are often severely toxic; even the new spate of immunocentric therapies proved highly dangerous when first administered. Several early recipients died due to clueless drug administration protocols. THAT's the reason we have Phase I. Humans usually respond differently to a drug than the animals who have gone before. That said, I think the FDA should approach cancer differently than other diseases, probably by establishing a new experimental model entirely (eliminating the Phase I/II/III system). Given that canger drugs and patients and protocols must ALWAYS be administered sensitively, circumstantially, and adaptively, the current 3 phase system seems to be serving cancer patients poorly, locking them into ineffective treatments for too long, based on too much emphasis on inflexible trial policy. Experimental protocols that are more adaptive and personalized are needed. Of course, this will be very hard technically and insanely expensive clinically. How to begin this? Like Obama, I'd love to see a 'moon shot' reinvention of the cancer business. Perhaps a project-based redesign of the system is possible, by engaging the most innovative cancer research clinicians and data analysts to explore alternative models for cancer research and drug trials. If that's what Obama has in mind, I support his wish. Now how do we make it work?

sjg007 11y ago
I meant in cases where the drug is already FDA approved e.g. Phase I trial has already been completed in other cancer types. There is no need to do another Phase I trial just because it is another cancer type. The restrictions on using an approved drug for a new cancer type or stage is silly. The original NCI program for treating Leukemias worked pretty well. The FDA is extremely risk adverse which is not what you want for terminal cancer treatment.

sjg007 11y ago

I meant in cases where the drug is already FDA approved e.g. Phase I trial has already been completed in other cancer types. There is no need to do another Phase I trial just because it is another cancer type. The restrictions on using an approved drug for a new cancer type or stage is silly. The original NCI program for treating Leukemias worked pretty well. The FDA is extremely risk adverse which is not what you want for terminal cancer treatment.