Abstract

FDA guidance outline methods for measuring meaningful change, and the results are increasingly used to inform regulatory decisions. Current best practice is to compute meaningful within-patient change (MWPC) using an anchor-based approach. The relationship between change scores and anchor groups is visualized via empirical cumulative distribution functions (eCDFs). However, when sample sizes within anchor groups are small, it may be difficult to compute the distribution function. In contrast, a scatterplot approach does not require any computation.

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