Monday, September 20, 2010

New Drugs Stir Debate on Basic Rules of Clinical Trials

http://www.nytimes.com/2010/09/19/health/research/19trial.html?_r=1&hp

If this was a randomized double-blind trial I could see Roche's argument, but what the hell is the point of having a control group if the study isn't blind? Needless suffering?

There are plenty of dead people from stage 3 and stage 4 melanom...a with the B-RAF mutation and tons of data on how long they survived on dacarbazine. Even if the FDA demanded a control group why not have the dacarbazine control group in Canada or another OECD country where Roche does not yet have approval nor is seeking approval for the new drug?If this was a randomized double-blind trial I could see Roche's argument, but what is the point of having a control group if the study isn't blind? Needless suffering?

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