Summary

Subject attrition from randomized Schizophrenia trials is a significant problem and has been found in meta-analysis to be as high as 76% (Robinowitz et al., 2005). High drop-out rates introduce selection bias, decrease the validity of intent to treat (ITT) analysis, can lead to a decrease in statistical power, and can ultimately cloud signal detection. The problem of drop-out is typically not addressed until the statistical analysis stage of the study which can decrease the validity of the results, increasing the likelihood of failed and negative trials.

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Retrospective Analysis of the Effects of Protocol Design on Completion Rates in Phase 1 Studies in Subjects with Stable Schizophrenia

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