Cutting Edge or Cutting Corners? Innovative Care

Abstract

Despite an ever-increasing body of scientific evidence, clinical situations often arise for which there are no well-accepted therapies. A physician may respond, for example, by using a drug “off-label” (i.e. to treat a condition for which it is not FDA-approved) or develop a new procedure with the aim of providing more benefit to the patient with less harm than standard approaches permit [1]. An innovative therapy is an unproven treatment approach used in clinical practice for the benefit of a patient. It contrasts with clinical research, which aims at testing the efficacy of an investigational therapy. However, since clinical practice and research often take place in the same facility under the supervision of the same physicians and the use of a novel therapy may both benefit a patient and generate new scientific knowledge, it is not always clear whether a novel therapy is innovative or investigational.