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Replicating the results of an animal study in large-scale human trials that then lead to regulatory approval has a success rate of around five to 10 per cent, based on several analyses

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"Nonetheless, our findings suggest that strengthening oversight and aligning incentives for timely reporting of results from clinical trials outlined in postmarketing requirements and commitments may be necessary to ensure postapproval evidence fulfills its intended role in promoting evidence-based clinical decision-making." JAMA

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