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FABAD
J. Pharm. Sci.
ISSN 1300-4182
Copyright Ó 2005
FABAD. All rights reserved
FABAD
J. Pharm. Sci., 28(2), 113-122, 2003. PDF
(217 KB)
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Scientific
Reviews
ABSTRACT
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REDUCING
THE BIAS IN CLINICAL TRIALS (RANDOMIZATION AND BLINDING)
Reha ALPAR*,o, Ali Kerem ULUDAĞ*
*Hacettepe
University, Faculty of Medicine, Department of Biostatistics,
06100 Sıhhiye, Ankara TURKEY
oCorresponding Author e-mail: ralpar@hacettepe.edu.tr
Summary:
The term bias in clinical trials describes the systematic
influence of any factors associated with the design, conduct
analysis, and interpretation of teh results. The two common
methods that are used to reduce the bias are randomization
and blinding. Randomization aims to obviate the systematic
differences (or bias) between groups due to the factors
other than the treatment. Randomization gives each patient
a known (usually egual) chance of being assigned to any
of the groups and it is based on the premise that the
group assignment cannot be predicted. Blinding (or masking)
is intended to limit the occurrence of conscious and unconscious
bias in the conduct and interpretation of a clinical trial
arising from the influence that the knowledge of treatment
may have on the recruitment and allocation of patients,
the responses of subjects to the treatments, the evaluation
of responses, the handling of withdrawals, the exclusion
of data from analysis , and so on. There are different
randomization and blinding methods. In this review, the
randomization and blinding methods used to reduce bias
will be discussed with appropriate examples.
Keywords:
Clinical trials, Bias, Randomization, Blinding.
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