Canadian Regulation, Safety Measures Stifling Clinical Research, Experts Say

The “one size fits all” approach to monitoring patient safety in clinical trials has led to a decline in the number of new research studies in developed countries and threatens access to new treatments, an editorial in the July Canadian Medical Association Journal (CMAJ) says. According to Paul Hebert, editor-in-chief of CMAJ, and Dean Fergusson, acting director of clinical epidemiology at Ottawa Hospital Research Institute, regulations aimed at protecting study participants “have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard.”
International Pharmaceutical Regulatory Monitor