- Non-inferiority studies should be done when a new treatment (or diagnostic modality) requires less resources (cost or time), is easier for the patient or has a lower side-effect profile.
- Non-inferiority study design largely negates the protections against bias added by blinding and randomization.
- Non-inferiority studies can be used to manipulate clinicians when a superiority study would be more appropriate.
REBEL Core Cast 8.0 – The NEJM + Non-Inferiority Studies
Click here for Direct Download of Podcast
Links:
- REBEL EM: Omadacycline, the NEJM and Non-Inferiority Studies
- First 10 EM: Andexanet Alfa: More Garbage Science in the New England Journal of Medicine
- EM Nerd: The Case of the Scientific Ruse
References:
- Stets R et al. Omadacycline for Community-Acquired Bacterial Pneumonia. NEJM 2019; 380(6): 511-27. PMID: 30726692
- O’Riordan W et al. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections. NEJM 2019; 380(6): 528-38. PMID: 30726689
- Lundh A et al. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Med 2018; 44(10): 1603-12. PMID: 30132025
Show Notes Written By: Miguel Reyes, MD (Twitter: @Miguel_ReyesMD)
Post Peer Reviewed By: Salim R. Rezaie, MD (Twitter: @srrezaie)
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