The IDDI team is excited to present our latest scientific poster about the new FDA guidance on DMCs (Data Monitoring Committees) and recommendations for Data Reporting Practices.
Poster Title:
New FDA Guidance on Data Monitoring Committees (DMCs) and Recommended Unblinded Data Reporting Practices for Effective Clinical Trial Oversight
Abstract:
The new FDA draft guidance on Data Monitoring Committees (DMCs) aims to update recommendations after nearly two decades, replacing the 2006 guidance. With evolving technology, study design shifts, and advancing industry standards, DMCs play an increasingly vital and complex role in clinical trials. This poster highlights key aspects of the updated FDA guidance, outlining the latest recommendations for DMC oversight, conduct, and best practices to consider when planning DMC involvement in clinical studies. It further offers recommendations for effectively reporting unblinded data to DMCs, facilitating informed decision-making to protect patient safety, upholding scientific integrity, and meeting economic needs of the sponsor.
Author: Kirby Morgan, Senior Biostatistician, IDDI
The poster was published and presented during the CNS Therapeutics Xchange 2024 taking place in Boston, MA on 24 June, 2024.