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

New Global GCP Standard Puts Proportionality In Focus For Trial Sponsors

 
• By Vibha Sharma

Pharma industry representative at the ICH expert working group that drew-up the new international good clinical practice standard is advising trial sponsors to focus on proportionality and a risk-based approach throughout their trial design, conduct, analysis and reporting.

Stack of zen stones in balance at seashore
All aspects of a clinical trial should match the risks to participants and results (Shutterstock)
Key Takeaways
  • Trial sponsors are being urged to review and update their standard operating procedures to comply with the new ICH E6(R3) guideline, which emphasizes a risk-based, proportionate approach to clinical trials.
  • Sponsors should focus on critical-to-quality factors throughout the trial, ensuring data integrity, clear responsibilities, and appropriate agreements to mitigate risks and ensure participant safety and data reliability.
  • In the EU, the E6(R3) guideline is set to come into force on 23 July 2025.

Clinical trial sponsors are being urged to review their standard operating procedures (SOPs) to ensure compliance with the International Council for Harmonisation’s revised good clinical practice guideline,

The updated guideline, which will replace the ICH’s E6(R2) as the GCP standard, will usher in major changes as it requires that clinical trial processes should be proportionate to the...

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

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

More from International

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.