Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

Touch the future,Interface technology, the future of user experience.

External or historical control arms are at the forefront of real-world use of real-world evidence (RWE) in regulatory decisions about efficacy. And Roche, having acquired Flatiron Health Inc. and its database of electronic health records, is at the head of the pack.

The company has already used external control arms generated from electronic health records (EHR) data in reimbursement negotiations for Alecensa...

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

Who Does What? EU RADIAL Study Exposes Oversight Challenges In Decentralized Trials

 
• By 

Decentralizing clinical research demands rethinking accountability and logistics to prevent gaps that could compromise safety and trial integrity.

France To Offer 14-Day Clinical Trial Reviews To Attract Research

 

France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.

Europe’s Trials@Home Findings Show Remote Recruitment Is Complicated

 
• By 

Europe’s RADIAL study comparing fully decentralized, hybrid and conventional trial approaches reveals why online recruitment is not simple.

UK Tests Standardized Site Selection Process For Streamlining Clinical Trial Setup

 
• By 

Sponsors and CROs planning commercial trials in the UK can now use a standardized template to confirm NHS site selection and start study setup activities in parallel with formal contracting and regulatory approvals.

More from R&D

UK Tests Standardized Site Selection Process For Streamlining Clinical Trial Setup

 
• By 

Sponsors and CROs planning commercial trials in the UK can now use a standardized template to confirm NHS site selection and start study setup activities in parallel with formal contracting and regulatory approvals.

Getting Comfortable With The Black Box: Explainable AI Techniques Build Trust

 

A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.

Pharma Needs Incentives To Optimize Cancer Drugs, EMA Oncology Chair Says

 

Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.