Expert-opinion on non-inferiority margin: A case study of oral anti-coagulant agents for prophylaxis of venous thromboembolic events after orthopedic surgery

Thrombosis Research

Volumn 131, Issue 4, 2013, Pages 368-371

  Wangge, Grace ^a   De Boer, Anthonius ^a   Klungel, Olaf H ^a   Hoes, Arno W ^b   Knol, Mirjam J ^b,c  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; ENOXAPARIN;

ATTRIBUTABLE RISK; CLINICAL DECISION MAKING; HUMAN; LETTER; ORTHOPEDIC SURGERY; PRIORITY JOURNAL; RISK FACTOR; THROMBOSIS PREVENTION; VENOUS THROMBOEMBOLISM;

CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; MALE; MIDDLE AGED; ORTHOPEDIC PROCEDURES; QUESTIONNAIRES; RISK ASSESSMENT; VENOUS THROMBOEMBOLISM;

EID: 84875747081     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2013.01.013     Document Type: Letter

References (8)

1. G. Wangge, O.H. Klungel, K.C.B. Roes, A. de Boer, A.W. Hoes, and M.J. Knol Room for Improvement in Conducting and Reporting Non-Inferiority Randomized Controlled Trials on Drugs: A Systematic Review PLoS One 5 2010 e13550
2. D.R. Holmes Jr., J.A. Becker, C.B. Granger, M.C. Limacher, Robert Lee Page II, and C. Sila ACCF/AHA 2011 Health Policy Statement on Therapeutic Interchange and Substitution A Report of the American College of Cardiology Foundation Clinical Quality Committee J Am Coll Cardiol 58 2011 1287 1307
3. V.L. Murthy, N.R. Desai, A. Vora, and D.L. Bhatt Increasing Proportion of Clinical Trials Using Noninferiority End Points Clin Cardiol 35 2012 522 523
4. ICH Expert Working Group Stastical principles for clinical trials E9 1998 1998
5. ICH Expert Working Group Choice of Control Group and Related Issues in Clinical Trials. E-10 2001 2001
6. Committee for Medicinal Products for Human Use (CHMP) Guideline on the choice of the non-inferiority margin EMEA/CPMP/EWP/2158/99 2005
7. Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) DRAFT GUIDANCE: Guidance for Industry Non-Inferiority Clinical Trials 2010
8. G. Wangge, K.C. Roes, A. de Boer, A.W. Hoes, and M.J. Knol The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants CMAJ Aug 20 2012 [Epub ahead of print]