Program Strategy
- Program Strategy
  We provide comprehensive services to guide you through the development and execution of a program strategy, across all stages of development and life cycle management, for drugs, biologics, and medical devices.
  Overview
Clinical Trials
- Clinical Trials
  Our global solutions leverage decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of international regulatory landscapes. Rho’s global team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more efficiently.
Marketing Applications
- Marketing Applications
  Marketing application submissions, including NDAs, BLAs, and MAAs, are the culmination of years of research and the final hurdle before a product makes it to market. Let our integrated team of experts get your product across the finish line.
  Overview
Government Partnerships
Why Rho
- Why Rho
Resources
- Resources
Careers
- Careers

Article

FDA Guidance on Non-Inferiority Clinical Trials to Establish Effectiveness

Heather Kopetskie

In November 2016, the FDA released final guidance on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness, along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. The guidance does not provide recommendations for how to evaluate the safety of a drug using a non-inferiority trial design. This article provides background on a non-inferiority trial design along with assumptions, advantages and disadvantages of the trial design.