Statistical Review – Non-Inferiority Trials with Dr. David Harrington

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Ever read a paper and feel a bit confused about all the statistical jargon and how to properly interpret the findings? At NEJM Resident 360, we’re bringing you Statistical Review which aims to cover some key areas in research methodology and trial design. On this episode, Dr Dave Harrington, our statistical editor here at the NEJM discusses non-inferiority trials, what they are and how they should be interpreted.

00:00 Introduction
02:15 What are non-inferiority trials?
03:12 Why do we use non-inferiority trials?
04:20 Key components
05:00 Non-inferiority margins, what are they and what do they mean?
05:22 How are non-inferiority margins defined?
06:38 Why use a 1-sided alpha?
07:10 How to interpret non-inferiority trials
08:23 Can non-inferiority trials demonstrated superiority?
09:40 What can’t a non-inferiority trial show?
10:22 How to interpret failed non-inferiority trials
11:50 Takeaways

Listen to the related podcast on Cardiovascular and Renal Outcomes in Type 2 Diabetes Medications with Dr. Marie McDonnell.

The Curbside Consults series complements the foundational information in NEJM R360 Rotation Prep by taking a deep dive into key clinical topics with expert clinicians and educators. These podcasts explore and critique the evidence behind clinical practice and break down statistical concepts for the busy clinical trainee.

 David Harrington is Emeritus Professor of Biostatistics and Statistics at Harvard T.H. Chan School of Public Health

 Angela Chen is a 2018-2019 NEJM editorial fellow. She is an endocrine fellow who trained at Flinders Medical Centre and the Royal Adelaide Hospital. Angela recieved her medical degree from the University of Adelaide, and masters of public health from the University of Sydney. Her clinical and research interests are in the areas of glucocorticoid and cardiovascular endocrinology and diabetes medicine.

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