title: Clinical trial: a clinician's perspective.
abstract: As a result of my participation in several clinical trials at The University of Iowa, I have now redrawn what I perceive to be the algorithm for conduct of a clinical trial. Of note, I have excluded the development of the new device, in vitro device testing, in vivo animal experimentation, clinical protocol development, granting of an Investigational Device Exemption, and the process by which clinical sites are selected. Following my algorithm I have made no mention of the commercialization of an experimental device, including the Pre-Market Approval process and FDA panel meetings. In summary, I believe there are a variety of reasons why a principal investigator would choose to participate in a clinical trial. With tongue in cheek, I would offer fame and fortune as two possible motivating factors. Obviously, both are double-edged swords. Should a trial not turn out as hoped, celebrity can instantly turn to notoriety. With respect to fortune, administrative and clinical activity performed by the principal investigator on behalf of the clinical trial does not generate income, and, in fact, can place a considerable financial drain on the investigator's department. I believe that investigators are strongly driven by intellectual curiosity, but it is important to maintain perspective when participating in a clinical trial. The real reason we seek clinical trial site designation is to allow us to offer new, innovative therapeutic modalities to our patients. By so doing, it is imperative that we conduct the clinical trial in as thoughtful and as safe a manner as possible, with our patients' well being always foremost in our minds.
authors.affiliation: Division of Cardiothoracic Surgery, The University of Iowa College of Medicine, Iowa City, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Richenbacher
mesh_terms: D002986:Clinical Trials as Topic; D004864:Equipment and Supplies; D006801:Humans