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Justification for clinical trials often substandard, study finds

Many of the animal studies that precede human clinical drug trials do not report sufficient evidence to justify those trials, a review has found.

The study, published in the journal PLOS Biology on 5 April, examined investigator brochures—the evidence presented to regulators and review boards to prove that a trial is justified.

It found that less than 5 per cent of a sample of these brochures included the information necessary to fully judge the efficacy of the proposed therapy in animal studies, such as on sample sizes and control groups. Furthermore, 89 per cent of the preclinical animal studies referred to were never published.

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