PubMed · 5326437
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A B Hill. 1966. Reflections on controlled trial.. https://doi.org/10.1136/ard.25.2.107
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Existing methods for power and sample size estimation for longitudinal and other clustered study designs have limited applications. In this paper, we review and extend existing approaches to improve these limitations. In particular, we focus on power analysis for the two most popular approaches for clustered data analysis, the generalized estimating equations and the linear mixed-effects models. By basing the derivation of the power function on the asymptotic distribution of the model estimates, the proposed approach provides estimates of power that are consistent with the methods of inference for data analysis. The proposed methodology is illustrated with numerous examples that are motivated by real study designs.
Most pharmaceutical statisticians make a contribution to drug development at the study level by designing and analysing clinical studies. There is less involvement at the drug project level, especially when it comes to making a strategic decision for a drug development program. Motivated by the assessment of drug safety, this paper presents a new decision rule on whether or not to continue developing a new drug based on a cost function. The cost function takes into account both type I and type II errors in a decision making problem. It also incorporates both the cost and benefit from a drug development program. This cost-benefit approach enables company senior management to evaluate a drug program objectively and make decisions in a quantitative and rational manner. The probabilities of making correct decisions are illustrated by using a real data example.
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