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I'm an undergraduate statistics student looking for a good treatment of clinical trials analysis. The text should cover the fundamentals of experimental design, blocking, power analysis, latin squares design, and cluster randomization designs, among other topics.

I have an undergraduate knowledge of mathematical statistics and real analysis, but if there's a fantastic text that requires a bit higher level of statistics or analysis, I can work up to it.

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up vote 6 down vote accepted

I would definitively recommend Design and Analysis of Clinical Trials: Concepts and Methodologies which seems actually the most complete one given your request.

Statistical Issues in Drug Development also covers a broad range of concepts but is less oriented toward design of experiment. Statistics Applied to Clinical Trials includes more technical stuff, but mainly focus on crossover trials and applications in epidemiology. And there is always the most famous Rothman, Modern Epidemiology, which provides valuable help for interpretation and examples of application of clinical biostatistics. Finally, The Design and Analysis of Clinical Experiments is more centered onto the analysis of specific experimental settings, but it does not address other points and is a bit older.

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It's difficult to go past Piantadosi's Clinical Trials: A Methodologic Perspective at least as a starting point. It is quite comprehensive and covers the topics you want and much more - including ethics, history, reporting, fraud, meta-analyses, randomisation, phases, suopping rules etc. - at an advanced undergraduate to early post-grad level.

The few times I was frustrated with it (the 1st edition anyway) where when it lacked sufficient detail - eg the derivations for sample size calculations. A comprehensive starting point!

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Experimental Design for the Life Sciences, by Ruxton & Colegrave, is a nice book and is aimed primarily at undergraduates.

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I was using "Fundamentals of Clinical Trials" when I was in PhD program.

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