Tools & techniques - Statistics: Non-inferiority trials

EuroIntervention

Volumn 10, Issue 4, 2014, Pages 526-527

  Collier, Timothy John ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CONTROL GROUP; DRUG ELUTING STENT; GOLD STANDARD; HUMAN; NON INFERIORITY CLINICAL TRIAL; NULL HYPOTHESIS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STATISTICAL ANALYSIS; STUDY DESIGN; METHODOLOGY; STATISTICS AND NUMERICAL DATA; TRENDS;

CLINICAL TRIALS AS TOPIC; HUMANS; RESEARCH DESIGN;

EID: 84930733285     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV10I4A90     Document Type: Article

References (4)

1. th General Assembly, Seoul, Korea, October 2008.
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): Choice of Control Group and Related Design and Conduct Issues in Clinical Trials (ICH E-10) Food and Drug Administration, DHHS, July 2000. http://www.fda.gov/ohrms/dockets/98fr/051401b.htm
3. von Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH, Stoel MG, Löwik MM, Linssen GC, Saïd SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet. 2014;383:413-23.
4. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295:1152-60.