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Chunk #9 — The Problems — Adherence to current CT norms does not prevent threats to validity

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Lost in translation: neuropsychiatric drug development.
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Consolidated Standards of Reporting Trials (CONSORT) were adopted to ensure that CT reports meet major journal editors’ standards for completeness of reporting (33), and CT registrations were undertaken to provide a record of human drug research (34). Nevertheless, these measures do not control fraudulent advertising (35), inadequate descriptions of methods in trial registrations (34), deviations from protocols (6, 24), failures to publish negative CT data (35 “spin” or misrepresentations of CT outcome implications (7), selective publications of data from a CT (8), measurement errors that undermine estimates of the magnitude of drug effects (3–6), and effects from inadequate preclinical preparations (2, 9, 10).