RAPS

When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance

The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...
The BMJOpinion

When the SPIRIT moves you: protocol changes can introduce bias in non-inferiority trials

Protocol fidelity and transparency about changes are essential to the credibility of randomised controlled trials In recent ...
Nasdaq

Outlook Therapeutics Reports Positive 12-Week Results for ONS-5010 in Wet AMD Non-Inferiority Trial and Plans BLA Resubmission for 2025

ONS-5010 shows non-inferiority to Lucentis at 12 weeks; BLA resubmission planned for Q1 2025, with $20.4M in proceeds expected. ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, ...
Harvard Business School

Human-Level Clinical Communication: A Randomized Non-Inferiority Evaluation of a GPT-4o Agentic Workflow for Patient-Portal Message Management

Moura Junior, Valdery, Peter Hadar, Susanna Gallani, Maria A. Donahue, Mamoon Habib, Hadi Kobaissi, Yousif Alsaadi, Brenda W. Chia, Gaurdia Banister, Rebecca Mishuris ...