Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol

Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol Publisher

Bang H¹ ; Flaherty SP² ; Kolahi J³ ; Park J²

Show Affiliations

1. Division of Biostatics and Epidemiology, Department of Public Health, Weill Medical College of Cornell University, New York, NY, United States
2. Asian Medicine and Acupuncture Research, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
3. Torabinejad Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

Source: Clinical Research and Regulatory Affairs Published:2010

Abstract

There is strong consensus in the clinical trial community that blinding is an important issue in randomized controlled trials. At present grossly incomplete reporting of procedures and the use of any assessment for blinding still prevails. The term 'double-blind' has almost become a convention without any checks or balances. Also there is a lack of consensus on quantitative procedures for evaluating the success of blinding in the literature. This article reviews statistical methods of blinding assessment along with software options, and discusses some of the most pressing issues surrounding the acquisition, interpretation, and reporting of blinding data. Finally, it proposes a sample blinding assessment protocol to address some of these issues. © 2010 Informa UK Ltd.

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Style	Citing Format
MLA	Bang H, et al.. "Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol." Clinical Research and Regulatory Affairs, vol. 27, no. 2, 2010, pp. 42-51.
APA	Bang H, Flaherty SP, Kolahi J, Park J (2010). Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol. Clinical Research and Regulatory Affairs, 27(2), 42-51.
Chicago	Bang H, Flaherty SP, Kolahi J, Park J. "Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol." Clinical Research and Regulatory Affairs 27, no. 2 (2010): 42-51.
Harvard	Bang H et al. (2010) 'Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol', Clinical Research and Regulatory Affairs, 27(2), pp. 42-51.
Vancouver	Bang H, Flaherty SP, Kolahi J, Park J. Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol. Clinical Research and Regulatory Affairs. 2010;27(2):42-51.
BibTex	@article{ author = {Bang H and Flaherty SP and Kolahi J and Park J}, title = {Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol}, journal = {Clinical Research and Regulatory Affairs}, volume = {27}, number = {2}, pages = {42-51}, year = {2010} }
RIS	TY - JOUR AU - Bang H AU - Flaherty SP AU - Kolahi J AU - Park J TI - Blinding Assessment in Clinical Trials: A Review of Statistical Methods and a Proposal of Blinding Assessment Protocol JO - Clinical Research and Regulatory Affairs VL - 27 IS - 2 SP - 42 EP - 51 PY - 2010 ER -

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Abstract