Poster Presentation: New FDA Guidance on Data Monitoring Committees (DMCs) and Recommended Unblinded Data Reporting Practices for Effective Clinical Trial Oversight
24 Jun 2024
Salon C
Clinical Studies
![Poster Presentation: New FDA Guidance on Data Monitoring Committees (DMCs) and Recommended Unblinded Data Reporting Practices for Effective Clinical Trial Oversight](https://cdn.asp.events/CLIENT_HubXchan_638DBA0F_0C6E_8D3C_A444829FC0C4B73E/sites/HubXChange/media/libraries/partners/IDDI.png/fit-in/1500x9999/filters:no_upscale())
The new FDA draft guidance on Data Monitoring Committees (DMCs) aims to update recommendations after nearly two decades, replacing the 2006 guidance.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.
Industry Expert