Clinical Investigation Of Medical Devices In Dentistry: Specification, Interpretation And Practical Guidance

Two German professors and one from Creighton University review the legal bases and requirements that should be observed when testing dental materials and devices in Europe and the U.S., and offer guidelines for designing and conducting a clinical study. They discuss contractual regulations between the clinical research unit and the sponsor, risk management, patient insurance, the ethics of the physician-patient relationship, common principal study designs, and statistical considerations. Annotation ©2004 Book News, Inc., Portland, OR (booknews.com)