Research methodology and practical issues relating to the conduct of a medical device registry

Volume: 16, Issue: 5, Pages: 490 - 501
Published: Jun 11, 2019
Abstract
Background The postmarket research goal is to assess “generalizability” or “external validity” to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal. Methods Although registries are common, in practice they follow the regulatory processes that appear designed primarily for...
Paper Details
Title
Research methodology and practical issues relating to the conduct of a medical device registry
Published Date
Jun 11, 2019
Volume
16
Issue
5
Pages
490 - 501
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