Posted by Michael Wonder on 29 Apr 2017
The wider role of regulatory scientists
27 April 2017 - Why they must help us improve the evidence base.
In 1990, a research scientist at the US FDA wrote in a letter to the New England Journal of Medicine, “I review many clinical-trial protocols. The results of some of these trials subsequently appear in the medical literature. On occasion, the published description of the study may differ from the prospective protocol in important aspects of study design or statistical analysis—eg, study size, clinical end-points, and statistical tests used. The potential for misuse … is tremendous.
