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Biomedical R&D can be strikingly complex. Through the persistent efforts of talented individuals from numerous fields we have a steady stream of medical innovation. Such fields include chemistry and clinical medicine, physics and pharmacokinetics, marketing, biology, toxicology, nursing, regulatory and finance. Statistical methods and concepts provide the means for processing the results which are intrinsic for clinical innovations.
Statistics gives life science the language to communicate its achievements and failures. Strategy and Statistics in Clinical Trials provides the tools for formulating judicious questions, designing optimal studies and testing succinct hypotheses.
Written in an accessible style with occasional humor, Strategy and Statistics makes for engaging reading and insightful discussion. The author presents the statistical view of clinical trials and provides a practical guide that contains extensive clinical case studies based on more than 20 years experience.
As biomedical research grows ever more complex, professionals need to understand their colleague’s work in order to communicate productively and move to the next step in the research process. Strategy and Statistics will provide the reader with the tools and framework to maximize efforts and reach objectives in this important process to achieve significant results.
• Enables non-statisticians to better understand research processes and statistics' role in these processes
• Offers real life case studies and provides a practical, "how to" guide to biomedical R & D
• Delineates the statistical building blocks and concepts of clinical trials
• Promotes effective cooperation between statisticians and important other parties
Chapter 1.) Clinical Development and Statistics: The General View
Chapter 2.) Questions when Planning Trials
Chapter 3.) Medical Product Attributes
Chapter 4.) Setting Research Objectives
Chapter 5.) Statistical Thinking
Chapter 6.) Estimation
Chapter 7.) From Description to Testing: A Beginning
Chapter 8.) Statistical Significance, Explanation and Prediction
Chapter 9.) Exploratory and Confirmatory Clinical Trials
Chapter 10.) One, Two, Three Testing: Hypothesis Testing and Multiplicity
Chapter 11.) Elements of Clinical Trial Design I: Putting it together
Chapter 12.) Elements of Clinical Trial Design II
Chapter 13.) Choosing Trial Endpoints
Chapter 14.) Determination of Sample Size
Chapter 15.) Concluding Remarks