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Chunk #15 — Two Examples — Case 1: Tarenflurbil for AD: Insufficient preparations for a CT

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Lost in translation: neuropsychiatric drug development.
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for the phase 2 trial failed to benefit from the drug, the investigators selected alternative outcomes (activities of daily living and global function ratings) that favored further tarenflurbil development. Drawing in this way on multiple comparisons (as a result of the post hoc analysis) increases the risk of positive outcomes as a result of chance and undermines the soundness of predictions based on the conclusions. The investigators may not have served themselves and their drug well by going into phase 3 trials without confirmation of the animal findings, with post hoc changes in statistical analyses, without confirming the phase 2 study, and with designs and analyses vulnerable to multiple comparisons.