What does 'non-inferior to' really mean? A clinician thinking out loud

Cerebrovascular Diseases

Volumn 29, Issue 6, 2010, Pages 607-608

  Ricci, Stefano ^a  

^a ASL 1 Dell' Umbria Ospedale   (Italy)

Author keywords

Clinical trials; Non inferiority trials; Treatment comparison

Indexed keywords

ACETYLSALICYLIC ACID; PLACEBO;

CLINICAL RESEARCH; CONFIDENCE INTERVAL; HEART INFARCTION; HUMAN; PRIORITY JOURNAL; RISK FACTOR; SAMPLE SIZE; SHORT SURVEY; STROKE;

CLINICAL TRIALS AS TOPIC; DRUG THERAPY; HUMANS; PAIN; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; TERMINOLOGY AS TOPIC;

EID: 77951086640     PISSN: 10159770     EISSN: None     Source Type: Journal    
DOI: 10.1159/000312869     Document Type: Short Survey

References (5)

1. Garattini S, Bertelè V: Non-inferiority trials are unethical because they disregard patients' interest. Lancet 2007; 370: 1875-1877.
2. European Medicines Agency: Guideline on the choice of the non-inferiority margin. 2006. www.ema.europa.eu/pdfs/human/ ewp/215899en.pdf (accessed February 9, 2010).
3. Piaggio G, Elbourne D, Altman D, Pocock S, Evans S; for the Consort group: Reporting on non inferiority and equivalence randomised trials. An extension of the CONSORT statement. JAMA 2006; 295: 1152-1160.
4. Hou Y, WU X, LI K: Issues on the selection of non-inferiority margin in clinical trials. Chin Med 2009; 122: 466-470.
5. Snappin S: Non-inferiority trial. Curr Control Trials Cardiovasc Med 2000; 1: 19-21