Principles-Based vs Prescriptive: How US & EU Compare In Their Approach To Decentralized Trials

In this regional comparison, regulatory experts at a US-based decentralized clinical trials (DCT) firm discuss their views on how the FDA’s draft DCT guideline compares with the pan-EU recommendation paper on this topic. This first segment of a two-part article dwells on the thinking behind why US and EU regulators tend to go down different paths. 

USA EU flag cracked wall background
US And EU Recommendations On Decentralized Trials Reflect The Philosophical Differences Between Regulators In The Two Regions • Source: Shutterstock

Both US and EU regulators recognize the important potential benefits and value of decentralized clinical trials (DCTs) and are keen to support such studies. Their respective guidelines on DCTs - issued just five months apart - are largely similar but have some notable differences.

The US Food and Drug Administration published its draft DCT guideline in May, with stakeholder comments being accepted until 1...

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

More from Clinical Trials

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By 

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By 

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

More from R&D

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By 

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.