Sample Size Estimation in Clinical Trial IAPSMUPUK：样本大小的估计在临床试验iapsmupuk.docVIP

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Sample Size Estimation in Clinical Trial IAPSMUPUK：样本大小的估计在临床试验iapsmupuk.doc

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Sample Size Estimation in Clinical Trial IAPSMUPUK：样本大小的估计在临床试验iapsmupuk

The Sample Size Estimation and its SAS Code For Binary Response Endpoints Clinical Study- A Review * Singh Rajneesh 1, Namdev Kuldeep Kumar 2 and Dr. Deepak 3 1 Biostatistician, Fortis Clinical Research Ltd, 2 Pharmacokinetic Scientist, Fortis Clinical Research Ltd, 3 Head Clinical Operation, Fortis Clinical Trial Clinical Research Ltd. Abstract: The aim of this article is to provide basic idea about sample size estimation in clinical study of binary response endpoints. Every clinical trial must be planned and it describes the objective, primary and secondary endpoint, method of collecting data, inclusion exclusion criteria, sample size with scientific justification, statistical methodology. The calculation of sample size with sufficient levels of significance and power is an essential part of protocol which needs to be submitted to drug authorities for approval. In this review emphasis has been made to describe the different kind of design i.e. equivalence, non-inferiority, superiority and equality and their SAS codes for sample size calculation in clinical study. Key: Significance Level (a), Power, Margin, Non-inferiority, Superiority. Introduction: The most important aspire of a sample size calculation is to determine the number of participants needed to detect a clinically relevant treatment effect. The determinants of sample size are the study design and the clinical end points scale level. *Correspondence Address: Rajneesh Singh, Biostatistician Fortis Clinical Research Ltd.,Sunflag Hospital Research Centre, Sector 16-A Faridabad – 121 002 India E-Mail:rajneesh.singh@ However, information needed to determine sample sizes are power, level of significance; size of the treatment effect, variation and others factors (e.g. drop-out rate or withdrawn rate). Statistical study designs are available to achieve objectives. Typical designs that may be employed are parallel group design, crossover design etc. The description of primary study end point should cover