I went looking for Placebo issues and came across this. Its Alzheimers related and looks to be a study assessment, even if the measurements and targets differ.
www.medavante.com\docs\default-source\pdf\placeholder-medavante-adas-cog-codr.pdf
I thought the conclusion very interesting:
Large variability and extreme outliers in visit-to-visit ADAS-Cog change scores, including those of a biologically implausible magnitude, were fairly common, suggesting significant error variance. Overall change on the ADAS-Cog over time was somewhat less than expected based upon published data. The percent of subjects who failed to worsen decreased over time with 45 percent of subjects not worsening by more than one point at 18 months. This is markedly less cognitive decline on placebo than previous
estimates3 and may therefore reflect a publication bias whereby failed trials are less likely to be reported in the peer-reviewed literature. Change on the ADAS-Cog was strongly dependent upon baseline MMSE, and visit-to-visit variability on the ADAS-Cog was fairly high. These findings suggest that accurate subject selection is critical for obtaining placebo decline on the ADAS-Cog, and that in-study quality control methodologies should be further explored for efficacy in reducing error variance.
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