Poor animal study design and reporting thwarts the ethical review of proposed human drug trials, according to a study in PLOS Biology led by researchers at Hannover Medical School (Germany), in cooperation with researchers from McGill University (Canada). Less than one-fifth of “investigator brochures” referenced animal studies that had been through a peer-reviewed publication process. Less than 20% of animal studies that tested the efficacy of the new drug described the use of simple techniques, like randomization blinding or sample size calculation, that can reduce the effects of bias. Of the more than 700 animal studies that the authors found in the investigator brochures, only 4% did not show positive effects of treatment. Chance alone should have resulted in more studies being negative.
Do you think regulatory authorities need to develop standards to ensure the rigorous design and reporting of preclinical animal studies when new drug trials are launched?