Medical Studies in Humans Often Launched on Faulty Evidence Base

April 9, 2018

(Reuters) – New research reveals serious flaws in the animal studies that regulators and ethicists use to decide if an experimental drug should be tested in humans. Dr. Daniel Strech, a bioethicist and professor at Hannover Medical School in Germany and his colleagues are the first to take an independent look at so-called investigator brochures (IBs), which regulatory agencies review to weigh the risks and benefits of the experimental treatment and determine whether trials in humans should move forward.

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