Thursday, July 04, 2019 1:02:48 PM
LESSON 5: PLACEBO DECLINE PROVIDES INSIGHT INTO THE POPULATION RECRUITED TO THE TRIAL
AD is a progressive disease and failure to observe decline in the placebo group in trials of 6 months or more duration is indicative of a failed trial.21 For DMTs, efficacy is determined by less rapid decline in the group on active therapy; lack of placebo decline indicates that the hypothesized superior efficacy of the active treatment was not tested and no conclusion regarding efficacy can be drawn. Lack of decline may sometimes be attributed to inclusion of non-AD patients into the trial (see Lesson 7 below). The lesson suggested is that failure of decline in a placebo group indicates operational flaws and a failed trial.
Note this comment in the paper:
Conflict of Interest
Dr Cummings has provided consultation to Abbvie, Acadia, Adamas, Anavex, Avanir, Avid, Axovant, Biogen, Boehinger-Ingelheim, Bracket, Dart, Eisai, Genentech, Lilly, Lundbeck, Medavante, Merck, Neurocog, Novartis, Otsuka, Pfizer, QR Pharma, Roche, Takeda, and Toyama pharmaceutical and assessment companies.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5866992/
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