Based on a Cardiac Safety Research Consortium Think Tank held in October 2017 on “Detection, Assessment, and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development, this publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
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Q&A: The Role of Expert Committees and the Regulatory Landscape
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.
The Role of Expert Committees: An interview with Dr. Seltzer
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...
Unique Challenges for Medical Device Clinical Trials
Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.
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 “The Role of Endpoint Adjudication in Medical Device Clinical Trials”.
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.
DMC Regulations May Change, but Principles Won't
Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials
Clinical event adjudication in cardiovascular device trials-FDA Perspective
Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development
Responsibilities of Data Monitoring Committees: Consensus Recommendations