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Re: Could someone discuss the placebo-reducing prescreening process? (I didn't quite understand what Daly described.)Response on Yahoo via Huck: I think the multi-step process goes like: 1. The MDD patient is recommended by their doctor based on trial inclusion criteria 2. There's additional vetting by subjecting the MDD patient/ candidate to a "survey" developed by Dr. Fava's group at MGH 3. During the trial, patients in the placebo group that do not get benefit will be re-randomized back into the trial I think that the four possible categories of participants are: Never Responders (Neither the drug nor placebo would show a benefit), Always Responders (they claim feeling a benefit regardless of whether being on drug or placebo), Placebo Only Responders (They start in the Placebo Group, say they feel a benefit) and Drug Only Responders (They are on drug and it works for them). The re-randomization of people from the placebo group who do not feel a benefit, is recognizing that those people are not affected by the "placebo effect", and it gives them another random chance to be put onto the drug. It makes sure, that if they are put into a drug cohort and given exposure to the drug, and then it failed them, that they truly were, "Never Responders". Likewise, if they were put into a drug cohort and it showed benefit, where placebo did not, that improves the drug's efficacy numbers and they become, "Drug Only Responders" |
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