A Case for Randomized, Double-Blinded, Sham-Controlled Class III Medical Device Trials

In this paper, I evaluate the ethical implications of the FDA’s move to en-courage randomized, double-blinded, sham-controlled trials for Class III devices when such studies are possible. In Part I, I describe the placebo effect and how researchers control for it. In Part II, I describe the results of studies of medical procedures and devices that have used a sham control. In Part III, I de-scribe the ethical concerns surrounding the use of sham surgeries to study medical devices.

In Part IV, I argue for the use of randomized, double-blinded, sham-controlled device trials, and propose an ethical framework for these studies.