doi: 10.1080/10543409508835115.
A useful testing strategy in phase III trials: combined test of superiority and test of equivalence
Affiliations
- PMID: 8580930
- DOI: 10.1080/10543409508835115
Item in Clipboard
A useful testing strategy in phase III trials: combined test of superiority and test of equivalence
J Biopharm Stat.
1995 Nov.
Abstract
A useful testing strategy is proposed for a confirmatory phase III clinical trial. It consists of a combined test of superiority and test of equivalence, and it is easy to apply. By introducing the strategy, we can perform a post hoc analysis in a confirmatory experiment. Thus a more flexible decision will be possible than the usual single testing method provides. It is shown that the procedure needs no adjustment for multiplicity from the point of view of the closed testing procedure. The relationship between this strategy and a confidence interval is also discussed.
Comment in
-
Issues of simultaneous tests for noninferiority and superiority.J Biopharm Stat. 2003 Nov;13(4):629-39; discussion 641-62. doi: 10.1081/BIP-120024199. J Biopharm Stat. 2003. PMID: 14584713
Similar articles
-
Issues of simultaneous tests for noninferiority and superiority.J Biopharm Stat. 2003 Nov;13(4):629-39; discussion 641-62. doi: 10.1081/BIP-120024199. J Biopharm Stat. 2003. PMID: 14584713
-
Decision-theoretic views on simultaneous testing of superiority and noninferiority.J Biopharm Stat. 2005;15(6):943-55. doi: 10.1080/10543400500265694. J Biopharm Stat. 2005. PMID: 16279353
-
A confirmatory strategy for therapeutic equivalence trials.Int J Clin Pharmacol Ther. 1995 Jul;33(7):388-90. Int J Clin Pharmacol Ther. 1995. PMID: 7582393
-
Methodology of superiority vs. equivalence trials and non-inferiority trials.J Hepatol. 2007 May;46(5):947-54. doi: 10.1016/j.jhep.2007.02.015. Epub 2007 Mar 9. J Hepatol. 2007. PMID: 17412447 Review.
-
A 25-year review of sequential methodology in clinical studies.Stat Med. 2007 Jan 30;26(2):237-52. doi: 10.1002/sim.2763. Stat Med. 2007. PMID: 17139691 Review.
Cited by
-
Carboplatin versus two doses of cisplatin in combination with gemcitabine in the treatment of advanced non-small-cell lung cancer: Results from a British Thoracic Oncology Group randomised phase III trial.Eur J Cancer. 2017 Sep;83:302-312. doi: 10.1016/j.ejca.2017.05.037. Epub 2017 Aug 4. Eur J Cancer. 2017. PMID: 28780466 Free PMC article. Clinical Trial.
-
A randomized, controlled, multicentre clinical trial of post-extraction alveolar ridge preservation.J Clin Periodontol. 2016 Dec;43(12):1188-1199. doi: 10.1111/jcpe.12623. Epub 2016 Oct 21. J Clin Periodontol. 2016. PMID: 27617409 Free PMC article. Clinical Trial.
-
Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease.BMC Surg. 2010 Apr 9;10:14. doi: 10.1186/1471-2482-10-14. BMC Surg. 2010. PMID: 20380708 Free PMC article. Clinical Trial.
-
A randomised, double masked, multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension.Br J Ophthalmol. 2003 Jan;87(1):57-62. doi: 10.1136/bjo.87.1.57. Br J Ophthalmol. 2003. PMID: 12488264 Free PMC article. Clinical Trial.
-
Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial.Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x. Diabet Med. 2008. PMID: 18387078 Free PMC article. Clinical Trial.
MeSH terms
LinkOut - more resources
Full Text Sources
Medical