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Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective

February 19, 2019

In this issue of the journal, Jonathan Seltzer presents an important review of the rationale and best practices for event adjudication in medical device clinical trials. The concepts presented in this work are well aligned with Food and Drug Administration's (FDA's) expectations for an adjudication process that enhances clinical study quality.

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This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “...

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