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

US FDA Will Leverage Current Clinical Trial Data In Deciding On Post-COVID Flexibilities

 
• By Sue Sutter

Oncology Center of Excellence’s Paul Kluetz says agency intends to explore the effects of decentralization, remote assessments and other approaches adopted mid-stream on safety evaluations, missing data and endpoint variability.

Yellow flag waving on the beach in the breeze against a blurred blue sky.
US FDA wants clinical datasets flagged for that period of time when a decentralized model was in place. • Source: Shutterstock

The US Food and Drug Administration has been lauded for the regulatory flexibility it has shown drug sponsors trying to navigate and mitigate the effects of the COVID-19 pandemic on ongoing and new clinical trials.

Agency guidance, issued quickly and regularly updated, has widely opened the door to decentralized trials with remote collection of efficacy...

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

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

More from R&D

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.