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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Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective
Most Recent Flipbooks
Save the Data. Protect the Patients. Prepare for What Comes Next: Remote Clinical Research Coordinators
Clinical Research Trends & Insights for 2020
16 industry experts share shifts and trends that will inform clinical research in 2020 and beyond.

Advances in Oncology Extend Lives, but Lead to New Safety Considerations for Sponsors and Investigators
From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations.

The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design

Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

Part 12: Public Awareness of Clinical Research and the Path to Diversity in Clinical Trials

Part 10: Unique Challenges and Opportunities for Emerging Biopharma Companies with Focused Pipelines

Part 6: Going Remote During COVID-19: Considerations When Moving Studies Out of the Clinic Setting