Literature DB >> 28797360

Challenges in the Design and Interpretation of Noninferiority Trials: Insights From Recent Stent Trials.

Fernando Macaya1, Nicola Ryan1, Pablo Salinas2, Stuart J Pocock3.   

Abstract

The noninferiority design is used extensively in current clinical research, but its complex features may hamper the appropriate interpretation of such trials. Thus, understanding the pillars of noninferiority design is indispensable. The authors discuss fundamental concepts regarding the design and interpretation of noninferiority trials and then explore some common methodological criticism by analyzing a sample of contemporary coronary stent trials. Finally, the authors give an overall perspective to enhance the design and conduct of future trials.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Keywords:  clinical trial; clinical trial design; coronary stent; noninferiority margin; sample size

Mesh：

Year:  2017        PMID： 28797360     DOI： 10.1016/j.jacc.2017.06.039

Source DB:  PubMed          Journal:  J Am Coll Cardiol        ISSN： 0735-1097            Impact factor:   24.094


  7 in total

1.  Journal Club Review of "Avacopan for the Treatment of ANCA-Associated Vasculitis".

Authors:  William Daniel Soulsby
Journal:  ACR Open Rheumatol       Date:  2022-02-15

2.  A critical analysis of the noninferiority design of the TALENT trial.

Authors:  S Saha; P Kerkar; N J Gogtay
Journal:  Indian Heart J       Date:  2020-02-14

3.  A German climbing study on depression: a bouldering psychotherapeutic group intervention in outpatients compared with state-of-the-art cognitive behavioural group therapy and physical activation - study protocol for a multicentre randomised controlled trial.

Authors:  Lisa Dorscht; Nina Karg; Stephanie Book; Elmar Graessel; Johannes Kornhuber; Katharina Luttenberger
Journal:  BMC Psychiatry       Date:  2019-05-17       Impact factor: 3.630

4.  Validation of an Independent Web-Based Tool for Measuring Visual Acuity and Refractive Error (the Manifest versus Online Refractive Evaluation Trial): Prospective Open-Label Noninferiority Clinical Trial.

Authors:  Robert P L Wisse; Marc B Muijzer; Francesco Cassano; Daniel A Godefrooij; Yves F D M Prevoo; Nienke Soeters
Journal:  J Med Internet Res       Date:  2019-11-08       Impact factor: 5.428

5.  Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation.

Authors:  Matteo Quartagno; A Sarah Walker; Abdel G Babiker; Rebecca M Turner; Mahesh K B Parmar; Andrew Copas; Ian R White
Journal:  Trials       Date:  2020-02-06       Impact factor: 2.279

6.  Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial.

Authors:  Seth Adu-Afarwuah; Rebecca R Young; Anna Lartey; Harriet Okronipa; Per Ashorn; Ulla Ashorn; Brietta M Oaks; Kathryn G Dewey
Journal:  J Nutr       Date:  2020-02-01       Impact factor: 4.798

7.  Two-Week Protocol Biopsy in Renal Allograft: Feasibility, Safety, and Outcomes.

Authors:  Manuel Lim; Byung Kwan Park; Kyo Won Lee; Jae Berm Park; Kyeong Deok Kim; Jaehun Yang; Jieun Kwon; Eun Sung Jeong; Seunghwan Lee
Journal:  J Clin Med       Date:  2022-01-31       Impact factor: 4.241
  7 in total

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