Poor animal study design and reporting thwarts the ethical review of proposed human drug trials, according to a study led by researchers at Hannover Medical School, Germany, in cooperation with researchers from McGill University, Canada. The study, publishing 5 April in the open access journal PLOS Biology, analyzed the descriptions of animal studies found in "investigator brochures" - the documents used by regulatory authorities and ethics committees to assess the potential efficacy of drugs that are being tested in patients for the first time.
Independent assessments of animal evidence are key to ensuring that patients are not exposed to undue risk when volunteering in trials. Based on documents obtained from three prominent German medical research centers, the study authors recommend that regulators need to develop standards to ensure the rigorous design and reporting of preclinical animal studies when trials of new drugs are launched.
Read more: http://www.worldpharmanews.com/research/4354-human-drug-trials-are-compromised-by-poor-reporting-of-animal-research