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The highest standards of clinical evidence are phase III randomised, double-blind, controlled clinical trials. Their significance to clinical medicine is given theoretically by the fact that patients as well as doctors are blind to the treatment and no bias can subvert patients’ assignments to either treatment arm. Their practical significance is established by the fact that a large majority of potential treatments that are apparently effective in early phase trials fail in phase III trials. The reasons for failure of phase III trials are multiple: from the clinical translation of potential therapies of doubtful significance even in animal models and the clinical testing of drugs that were only tested in vitro during preclinical development, to inadvertent bias in patient selection in early phase trials (sometimes mandated by the characteristics of early phase clinical protocols).1
Dey et al2 provide …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.