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Infuse Open-Access Project A Model For The Future? Medtronic Thinks So

 
• By David Filmore

Two independent analyses published on Medtronic’s Infuse biologic bone graft do not paint a positive picture for the device, but they do represent an important model for the future of open-access data analysis for drugs and devices, both Medtronic and academic proponents say.

Medtronic is touting data for its Infuse bone graft that is not particularly positive for the product. Not only that, it heralded the release of the data as a paradigm-shifting event.

Industry analysts don’t expect that findings from two independent analyses of the product, based on raw data handed over by...

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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.

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