1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Data Monitoring Committees Can Support Certain Adaptive Design Trials, US FDA Says

 
• By Brenda Sandburg

Draft guidance describes evolution of DMCs and their responsibilities for monitoring trial conduct, internal analyses and external data.

Clinical trial monitoring
FDA issues draft guindance on use of data monitoriing committees in clinical trials • Source: Shutterstock

Almost 18 years after its last formal recommendations on the topic, the US Food and Drug Administration notes the significant changes in the structure and practice of clinical trial data monitoring committees in new draft guidance for sponsors.

Key Guidance Recommendations

  • Using a DMC instead of an independent adaptation body to support adaptive trials might best be reserved for relatively straight forward designs.

  • DMCs...

The draft guidance, “Use of Data Monitoring Committees in Clinical Trials,” revises a guidance issued in 2006. (Also see "Data Monitoring Committees" - Pink Sheet, 29 March, 2006.)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

More from R&D

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.