Pharmaceutical Industries

The U.S. Food and Drug Administration (FDA) issued a Guidance for Industry in 2008 defining pre-approval and post-approval requirements for the demonstration of cardiovascular safety for all new medications developed for glycemic management in type 2 diabetes. Seventeen large, prospective, randomized, controlled clinical trials involving more than 140,000 subjects thus far have been completed or are ongoing in accordance with this guidance. There is a need for reassessment of this situation (Smith et al, Diabetes Care 2016). Recruitment of high risk subjects, in line with FDA guidance, is feasible using our PRS as an inclusion criteria. The resulting increase of event rate by 2-fold for myocardial infarction, 3-fold for stroke and heart failure and for 4-fold for cardiovascular death will result in significant cost savings for Pharmas by either reducing the number of participants needed or by shortening trial duration.