Sample Size Calculations in Clinical Research (2nd Edition) by Jun Shao, Shein-Chung Chow, Hansheng Wang

By Jun Shao, Shein-Chung Chow, Hansheng Wang

A finished and unified presentation of statistical ideas and functional purposes, this e-book highlights the interactions among clinicians and biostatisticians, encompasses a well-balanced precis of present and rising scientific concerns, and explores lately constructed statistical methodologies for pattern measurement calculation. at any time when attainable, every one bankruptcy presents a quick background or history, regulatory requisites, statistical designs and strategies for information research, real-world examples, destiny examine advancements, and comparable references.

Focusing on an essential component of pharmaceutical improvement, pattern dimension Calculations in medical study, moment version offers statistical techniques for appearing pattern measurement calculations in the course of numerous levels of medical study and improvement. It presents pattern measurement formulation and approaches for trying out equality, noninferiority/superiority, and equivalence.

One of the few books to systematically summarize scientific study strategies, this variation includes new chapters that concentrate on 3 key parts of this box. Incorporating the fabric of this booklet on your paintings can help make sure the validity and, eventually, the luck of your medical experiences.

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Additional info for Sample Size Calculations in Clinical Research (2nd Edition) (Chapman & Hall/CRC Biostatistics Series)

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N2 (control). Assume that x1i and x2i are independent and normally distributed with means µ1 and µ2 and common variances σ 2 , respectively. The hypotheses of interest are H0 : µ1 = µ2 versus H1 : µ1 = µ2 . When σ 2 is known, we reject H0 at the 5% level of significance if and only if |T | > tn−2 , where tn−2 is the (1 − α/2)th percentile of the t-distribution with n − 2 degrees of freedom, n = n1 + n2 , T = ¯2 x ¯1 − x (n1 −1)s21 +(n2 −1)s22 n−2 , 1 n1 + 1 n2 and x ¯i and s22 are the sample means and variances calculated based on data from the ith group, respectively.

If there are one or more successes in stage 1, then stage 2 is implemented by including the other n2 subjects. A decision is then made based on the response rate of the n1 +n2 subjects. The drawback of Simon’s design is that it does not allow early termination if there is a long run of failures at the start. To overcome this disadvantage, Ensign et al. (1994) proposed an optimal three-stage design which modifies the Simon’s two-stage design. Let p0 be the response rate that is not of interest for conducting further studies and p1 be the response rate of definite interest (p1 > p0 ).

Formulas are derived under different hypotheses testing for equality, superiority, non-inferiority, and equivalence with equal or unequal treatment allocation. In addition, sample size calculation based on Bayesian approach is also considered in this chapter. Chapter 4 deals with sample size calculation for comparing proportions based on large sample tests. Formulas for sample size calculation are derived under different hypotheses testing for equality, superiority, noninferiority, and equivalence with equal or unequal treatment allocation.

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