Requiring an amyloid-β1-42 biomarker may improve the efficiency of a study, and simulations may help in planning studies 英文参考文献.docVIP

Hendrix Alzheimer’s Research Therapy 2011,3:10 /content/3/2/10 VIE WPOINT Requiring an amyloid-β biomarker may improve 1–42 the e? ciency of a study, and simulations may help in planning studies Suzanne B Hendrix* e di? er ence between group means divided by the SD is Abstract called a standardised di? erence (or Cohen’s D value [2]) A recent article by Schneider and colleagues has generated a lot of interest in simulation studies as a way to improve study design. The study also illustrates the foremost principal in simulation studies, which is that the results of a simulation are an embodiment of the assumptions that went into it. This simulation study assumes that the e?ect size is proportional to the mean to standard deviation ratio of the Alzheimer Disease Assessment Scale – cognitive subscale in the population being studied. Under this assumption, selecting a subgroup for a clinical trial based on biomarkers will not a?ect the e?ciency of the study, despite achieving the desired increase in the mean to standard deviation ratio. and allows estimation of power based on a t test. If you take the placebo group mean and subtract the treatment group mean and then divide that di? erence by the placebo SD, using numbers that are all shown in the table, you obtain the e? ect size shown in the third column, within the rounding err is exercise illustrates that the e? ect size used in this simulation study increases and decreases proportionally to the standardised di? erence, which is tied mathe mati- cally to the power. In other words, although the sensi- tivity of the ADAS-cog to decline over time is increased with the biomarker selection methods, the treatment di? erence was decreased in order to maintain the same standardised di? erence. Although this same type of approach seems to have been taken for the Clinical Dementia Rating scale sum of boxes (CDR-sb), calculatin