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.
This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “...
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This publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
Dr. Seltzer, president and founder of ACI Clinical, and chief scientific officer of WCG Clinical, shared his insights on expert committees during a recent conversation with Bill Stedman.
What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Scientific Officer of WCG Clinical, shared his insights on expert committees during a recent...
Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”.
This article provides a practical guide to sponsors, institutions, and individuals responsible for, or serving on, a DMC.