Clinical investigations: taking a global approach, part I.
Clinical investigations are a vital part of the development process of a medical device.  A number of advantages can be gained by initiating a global approach to clinical investigation and implementing a well-designed, multinational, multicentred programme.  It can mean that market approval can be accelerated and that the marketing effort is supported in specific countries, which can lead to greater market share. This article, which will be published in two parts, outlines the strategy that is required to set up and implement an effective global clinical investigation.  Part I considers the elements that are involved and defines the advantages of adopting this approach.
Schaefer
J F
JF
Davis & Geck Division, American Cyanamid, Wayne, New Jersey.
Jessup
G
G
D002986:Clinical Trials as Topic / Q000592:standards*; D004867:Equipment Design / Q000592:standards*; D004869:Equipment Safety; D006801:Humans; D007391:International Cooperation; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000379:methods / Q000592:standards; D011786:Quality Control