The Use of Restricted Significance Tests in Clinical Trials

1. Front Matter

   Pages i-x

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2. Philosophical and Scientific Problems when Applying Statistical Methods to Clinical Data

   1. Front Matter

      Pages 1-1

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   2. The Randomized Controlled Clinical Trial

      • David S. Salsburg

      Pages 3-9

   3. Probability Models and Clinical Medicine

      • David S. Salsburg

      Pages 10-21

   4. Significance Tests Versus Hypothesis Tests

      • David S. Salsburg

      Pages 22-29

   5. Neyman’s Insights

      • David S. Salsburg

      Pages 30-38

   6. Reconciling Fisher and Neyman

      • David S. Salsburg

      Pages 39-46

3. Techniques for Applying Restricted Tests to Data from Randomized Controlled Clinical Trials

   1. Front Matter

      Pages 47-47

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   2. Continous Measures Taken over Time

      • David S. Salsburg

      Pages 49-59

   3. Combining Data Across Measures

      • David S. Salsburg

      Pages 60-77

   4. Counts of Events

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      Pages 78-88

   5. Permutation Tests and Resampling Techniques

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      Pages 89-96

   6. Neyman’s Restricted Chi Square Tests

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      Pages 97-103

   7. Miscellaneous Methods for Increasing Power

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      Pages 104-114

   8. Bayesian Estimation

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      Pages 115-125

   9. An Example of the Type of Analysis Suggested in This Book

      • David S. Salsburg

      Pages 126-160

4. Back Matter

   Pages 161-174

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The reader will soon find that this is more than a "how-to-do-it" book. It describes a philosophical approach to the use of statistics in the analysis of clinical trials. I have come gradually to the position described here, but I have not come that way alone. This approach is heavily influenced by my reading the papers of R.A. Fisher, F.S. Anscombe, F. Mosteller, and J. Neyman. But the most important influences have been those of my medical colleagues, who had important real-life medical questions that needed to be answered. Statistical methods depend on abstract mathematical theorems and often complicated algorithms on the computer. But these are only a means to an end, because in the end the statistical techniques we apply to clinical studies have to provide useful answers. When I was studying martingales and symbolic logic in graduate school, my wife, Fran, had to be left out of the intellectual excitement. But, as she looked on, she kept asking me how is this knowledge useful. That question, what can you do with this? haunted my studies. When I began working in bio­ statistics, she continued asking me where it was all going, and I had to explain what I was doing in terms of the practical problems that were being ad­ dressed.

• Master Patient Index
• Radiologieinformationssystem
• Resampling
• methodology
• statistics

"...A broad range of statistical methodologies is surveyed including restricted chi-square tests, normal theory tests, nonparametric tests, permutation and resampling methods and Bayesian estimation...For anyone who wants to think deeply about the basic issues involving the design and analysis of clinical trials, this book is a must read.."(Zentralblatt für Mathematik)

• Pfizer Research Division, Pfizer, Inc., Groton, USA

  David S. Salsburg

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