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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Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing ev
Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing ev

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

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DMC Regulations May Change, but Principles Won't
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