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 ...
RAPS

EMA proposes new guideline on non-inferiority trials

The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new drugs in clinical trials. The proposal aims ...
BMJ

Economic evaluations in ‘non-inferiority’ trials: can costs guide decisions between surgical and non-surgical interventions?

Correspondence to Professor Steven M McPhail, Australian Centre for Health Services Innovation, Queensland University of Technology, Kelvin Grove, QLD 4059, Australia; steven.mcphail{at}qut.edu.au ...
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, ...
ascopubs.org

ROCC/GOG-3043: A randomized non-inferiority trial of robotic versus open radical hysterectomy for early-stage cervical cancer.

Randomized controlled trial of the efficacy of lymph node dissection on stage IIICr of cervical cancer (CQGOG0103). Background: Minimally invasive surgery (MIS) is associated with improved ...