Placebo data and weighting

From: Gobburu, Jogarao V Subject: Placebo data and weighting Date: Friday, January 18, 2002 8:36 AM Hello, Now, I do not know anything about your drug and the population from the email. But I have some general comments to make. 1. Why do you consider that getting negative drug effect is nonsense in some individuals? It could be that they are non-responders. 2. You talk about placebo effect, what about disease progression? May be this is why in some patients, who either did not receive 'enough' drug or poor responders, the drug effect is over-shadowed by the disease progression. 3. It would benefit if you explained what 'weight' function was used and its rationale. 4. Ideally simulataneous analysis of all the data is preferred. Regards, Joga Gobburu, Pharmacometrics, CDER, FDA