Drug and device trials: should we ask more.

摘要

Drug and Device development are often different, especially since a device is frequently modified, while once a drug enters clinical trials its chemical composition remains constant. Additionally, device therapy is often impossible to blind without using techniques such as sham procedures, which can be ethically unacceptable. This inability to blind a procedure and the need to compare to an alternative therapy often leads to non inferiority studies. While non inferiority studies are more difficult to design, they are useful and can effectively evaluate one therapeutic approach over another. While some argue for superiority trials, it is incorrect to believe an intervention must be superior to another to be approvable by a regulatory body or used by clinicians.