Noninferiority trials in clinical practice

被引:0
作者
Marko, Monika [1 ]
Pawliczak, Rafal [1 ]
机构
[1] Uniwersytet Med Lodzi, Zaklad Immunopatol, Wydzial Lekarski, Oddzial Nauk Biomed, Ul Zeligowskiego 7-9,Bud 2,Kl 2,Pok 177, Lodz, Poland
关键词
noninferiority trials; clinical practice; drugs' efficacy; SYSTEMATIC REVIEWS; EQUIVALENCE;
D O I
10.5114/pja.2019.91219
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
With the development of new therapeutic strategies, it is becoming increasingly difficult to develop drugs that show better efficacy. That is why new treatments are being sought that have similar efficacy, but in other respects show better quality. This trend stimulates the development of clinical trials aimed at demonstrating that experimental treatment is not (much) worse than control treatment. Such studies are called noninferiority trials, which we describe in this paper in relation to superiority trials and equivalence trials. We also pay attention to the problems you may encounter when conducting noninferiority trials.
引用
收藏
页码:152 / 159
页数:8
相关论文
共 24 条
[1]   Incorporating Patient Preferences in Noninferiority Trials [J].
Acuna, Sergio A. ;
Chesney, Tyler R. ;
Baxter, Nancy N. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2019, 322 (04) :305-306
[2]   Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival A Pooled Analysis [J].
Addeo, Alfredo ;
Weiss, Glen J. ;
Gyawali, Bishal .
JAMA NETWORK OPEN, 2019, 2 (05)
[4]  
[Anonymous], 1998, STAT PRINC CLIN TRIA
[5]  
[Anonymous], DRAFT GUID IND NON C
[6]   Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics [J].
D'Agostino, RB ;
Massaro, JM ;
Sullivan, LM .
STATISTICS IN MEDICINE, 2003, 22 (02) :169-186
[7]   Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial [J].
Diercks, Gillian R. ;
Comins, Jill ;
Bennett, Kara ;
Gallagher, Thomas Q. ;
Brigger, Matthew ;
Boseley, Mark ;
Gaudreau, Philip ;
Rogers, Derek ;
Setlur, Jennifer ;
Keamy, Donald ;
Cohen, Michael S. ;
Hartnick, Christopher .
JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY, 2019, 145 (06) :494-500
[8]   Communication of Nonefficacy Benefits of NewDrugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017 [J].
Doshi, Peter ;
Spence, O'Mareen ;
Kuzucan, Aida ;
Powers, John H., III .
JAMA INTERNAL MEDICINE, 2019, 179 (05) :719-721
[9]   Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011 [J].
Doshi, Peter ;
Hur, Peter ;
Jones, Mark ;
Albarmawi, Husam ;
Jefferson, Tom ;
Morgan, Daniel J. ;
Spears, Patricia A. ;
Powers, John H., III .
JAMA INTERNAL MEDICINE, 2017, 177 (10) :1452-1459
[10]   Indirect comparisons of treatments based on systematic reviews of randomised controlled trials [J].
Edwards, S. J. ;
Clarke, M. J. ;
Wordsworth, S. ;
Borrill, J. .
INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, 2009, 63 (06) :841-854