FDA’s real-time clinical trials initiative may have real, but unexpected, benefits

FDA launched its real-time clinical trials initiative with promises of sweeping away 60 years of tradition. Former agency leaders say the program’s real payoff is likely to be its unglamorous data plumbing. The benefits of real-time transfer to FDA are more uncertain. 

The RTCT program is essentially a multivariate experiment. One variable involves process improvements, while the other changes the relationship between regulators and sponsors by turning trials into continuously supervised events. ...