COLLECTING INFORMATION WITHOUT A RANDOMIZED TRIAL.

COLLECTING INFORMATION WITHOUT A RANDOMIZED TRIAL. I quoted yesterday a doctor’s statement that: “The only way to verify the hypothesis that skin rash predicts the benefit of cetuximab [Erbitux] is a randomized trial….” Another way to learn more about the predictive power of the skin rash is to increase greatly the use of Erbitux on patients suffering from this disease and to keep track of what happens to each of them during the course of treatment. In addition to what I think are ethical advantages, I think that you would get a lot more information more quickly. (Waiting to see if a randomized study confirms the initial result would seem to take some 15 months after the randomized test is designed.) The important number here is the increase of over 6 months in survival rates. If that holds up, it should be noticeable even in a large number of patients with a lot of statistical noise. And there would be a larger number of patients whose medical histories could be investigated for further leads. For that matter, there is no reason a broader study could also be done alongside a randomized trial.