Innovations in surgery. A proposal for phased clinical trials.
There is an urgent need for the staged, controlled, introduction of new technology and new procedures to surgery. A classification system in four stages is proposed, which would allow for prospective assessment of new devices or methods before they are released for use by the surgical community. The proposal recognises the unique nature of a surgical operation and its learning curve. The issues of randomisation and of informed consent are discussed, and are shown not to be barriers to clinical trials, but necessary adjuncts to orderly testing. The importance of continued surveillance of innovations is emphasised.
Gross
M
M
Dalhousie University, Halifax, Nova Scotia, Canada.
D000818:Animals; D015331:Cohort Studies; D004195:Disease Models, Animal; D005500:Follow-Up Studies; D006801:Humans; D007258:Informed Consent; D009985:Orthopedics / Q000379:methods / Q000592:standards*; D011159:Population Surveillance; D016032:Randomized Controlled Trials as Topic; D012106:Research / Q000145:classification / Q000592:standards; D012107:Research Design / Q000592:standards; D013514:Surgical Procedures, Operative / Q000379:methods / Q000592:standards*