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[Discussion on Design of Clinical Trial Protocol of Laser Medical Devices]
Jianyuan Wu1, Zhimin Huang2, Junlong Cai1
1Clinical Trial Center of Zhongnan Hospital, Wuhan University, Wuhan, 430071.
Abstract:
Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.
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