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Comparative Study
Good statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices.
- Nelson Lu, Yunling Xu, and Lilly Q Yue.
- a Food and Drug Administration, Center for Device and Radiological Health, U.S ., Silver Spring , MD , USA.
- J Biopharm Stat. 2019 Jan 1; 29 (4): 580-591.
AbstractObservational (non-randomized) comparative studies have been adopted in the pre-market safety/effectiveness evaluation of medical devices. There has been an increased interest in utilizing this design with the growing available real-world data. However, in such studies, biases that are introduced in every stage and aspect of study need to be addressed. Otherwise, the objectivity of study design and validity of study results will be compromised. In this paper, challenges and opportunities are discussed from the regulatory perspective. Considerations and good statistical practice to mitigate the potential bias are presented.
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