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Good [2006] provides a series of anecdotes concerning the mythical Bumbling Pharmaceutical and Device Company that amply illustrate the results of inadequate planning. See also Andersen [1990] and Elwood [1998]. The opening chapters of Good [2001] contain numerous examples of courtroom challenges based on misleading or inappropriate samples. See also Copas and Li [1997] and the subsequent discussion.

Definitions and a further discussion of the interrelation among power and significance level may be found in Lehmann [1986], Casella and Berger [1990], and Good [2001]. You will also find discussions of optimal statistical procedures and their assumptions.

Lachin [1998], Lindley [1997], and Linnet [1999] offer guidance on sample size determination. Shuster [1993] provides sample size guidelines for clinical trials. A detailed analysis of bootstrap methodology is provided in Chapters 5 and 7 of this book.

Rosenberger and Lachin [2002] and Schulz and Grimes [2002] discuss randomization and blinding in clinical trials.

Recent developments in sequential design include group sequential designs, which involve testing not after every observation, as in a fully sequential design, but rather after groups of observations, for example, after every 6 months in a clinical trial. The design and analysis of such experiments is best done using specialized software such as S+SeqTrial from http://spotfire.tibco.com/products/s-plus/statistical-analysis-software.aspx. For further insight ...

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