Editorial

. 2023 Oct;37(15):3059-3060.

doi: 10.1038/s41433-023-02465-4. Epub 2023 Mar 3.

Noninferiority randomised trials in ophthalmology

Collaborators, Affiliations

Collaborators

Retina Evidence and Trials INternational Alliance (R.E.T.I.N.A.) Study Group:
Sobha Sivaprasad, Peter Kaiser, David Sarraf, Sophie J Bakri, Rishi P Singh, Frank G Holz, Tien Y Wong

Affiliations

¹ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
² Population Health Research Institute, Hamilton, ON, Canada.
³ Division of Internal Medicine, McMaster University, Hamilton, ON, Canada.
⁴ Retina Consultants of Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.
⁵ Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, PA, USA.
⁶ Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, VIC, Australia.
⁷ Department of Surgery (Ophthalmology), The University of Melbourne, Melbourne, VIC, Australia.
⁸ Biostatistics Unit, St. Joseph's Healthcare-Hamilton, Hamilton, ON, Canada.
⁹ Department of Surgery, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.
¹¹ Department of Surgery, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.

^# Contributed equally.

PMID: 36869135
PMCID: PMC10564920
DOI: 10.1038/s41433-023-02465-4

Editorial

Noninferiority randomised trials in ophthalmology

Kevin Kim et al. Eye (Lond). 2023 Oct.

. 2023 Oct;37(15):3059-3060.

doi: 10.1038/s41433-023-02465-4. Epub 2023 Mar 3.

Authors

Collaborators

Retina Evidence and Trials INternational Alliance (R.E.T.I.N.A.) Study Group:
Sobha Sivaprasad, Peter Kaiser, David Sarraf, Sophie J Bakri, Rishi P Singh, Frank G Holz, Tien Y Wong

Affiliations

¹ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
² Population Health Research Institute, Hamilton, ON, Canada.
³ Division of Internal Medicine, McMaster University, Hamilton, ON, Canada.
⁴ Retina Consultants of Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.
⁵ Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, PA, USA.
⁶ Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, VIC, Australia.
⁷ Department of Surgery (Ophthalmology), The University of Melbourne, Melbourne, VIC, Australia.
⁸ Biostatistics Unit, St. Joseph's Healthcare-Hamilton, Hamilton, ON, Canada.
⁹ Department of Surgery, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.
¹¹ Department of Surgery, McMaster University, Hamilton, ON, Canada. vchaudh@mcmaster.ca.

^# Contributed equally.

PMID: 36869135
PMCID: PMC10564920
DOI: 10.1038/s41433-023-02465-4

No abstract available

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

**Fig. 1. Illustration of Possible Outcome Scenarios in Non-Inferiority Trials.**
Listed possible outcome scenarios in non-inferiority trials (A–E) interpreted based on the “line of no difference” and the noninferiority margin.

See this image and copyright information in PMC

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References

1. ICH. International Council for Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human (ICH) Use Topic E 10—choice of control group in clinical trials. 2001;1999. 10.1299/kikaic.61.4696
1. US Food and Drug Administration, CDER. Non-inferiority clinical trials to establish effectiveness guidance for industry. 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...
1. Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399:729–40. doi: 10.1016/S0140-6736(22)00010-1. - DOI - PubMed
1. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–31. doi: 10.1056/NEJMoa054481. - DOI - PubMed
1. Coassin M, De Maria M, Mastrofilippo V, Braglia L, Cimino L, Sartori A, et al. Anterior chamber inflammation after cataract surgery: a randomized clinical trial comparing bromfenac 0.09% to dexamethasone 0.1% Adv Ther. 2019;36:2712–22. doi: 10.1007/s12325-019-01076-4. - DOI - PubMed

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Noninferiority randomised trials in ophthalmology

Collaborators

Affiliations

Noninferiority randomised trials in ophthalmology

Authors

Collaborators

Affiliations

Conflict of interest statement

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