Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial |
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| Authors: | Christoph Bartl Dirk Stengel Thomas Bruckner Inga Rossion Steffen Luntz Christoph Seiler Florian Gebhard |
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| Affiliation: | 1. Statistics Collaborative, Inc., Suite 600, 1625 Massachusetts Avenue NW, Washington, DC, 20036, USA
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| Abstract: | Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration. |
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