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

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.

Previous Flipbook
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 “...

Next Flipbook
Small Biotechs, Big Safety Data Responsibility
Small Biotechs, Big Safety Data Responsibility

New Blog: "Ask the IRB Experts"

Visit Blog