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Thursday, December 01, 2016 3:24:08 AM
The placebo-controlled trials that the Agency relies on to support a finding of substantial evidence of effectiveness vary considerably in duration. Treatments designed to treat acute migraine headache typically study only a single headache (because subsequent headaches are intermittent and considered independent events that are expected to respond equally to treatment), while treatments for various forms of multiple sclerosis may have controlled portions of up to 2 years. As a general principle, studies of treatments for chronic conditions should (and do) assess drug effect for at least 3–6 months in a controlled setting, but the duration may need to be longer if the number of events necessary to be able to detect a drug-placebo difference are relatively rare (for example, studies of relapsing-remitting multiple sclerosis (MS) may need to be 1–2 years long in order for enough relapses to occur to be able to detect a between-treatment difference). Some studies of the acute phase of relatively chronic conditions [e.g., acute major depressive disorder (MDD), acute schizophrenia] are relatively brief (2–8 weeks), largely because patients cannot continue placebo treatment for very long (there are too many discontinuations after this duration to be able to adequately analyze the trial). In all instances in which prolonged treatment with placebo is untenable or clinically questionable, protocols contain contingencies to “rescue” patients with effective treatments.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534930/
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