Fundamental Concepts for New Clinical Trialists

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Gewicht:
694 g
Format:
234x156x22 mm
Beschreibung:
With complete coverage of issues in all phases of clinical trials, including design, data monitoring, analyses, interpretation, and reporting, this book provides an overview of fundamental concepts important to statisticians working with clinical trials. It examines issues related to product development and regulation, and then discusses the attributes that statisticians can acquire to maximize their contribution to the research. The co-authors draw on their experience in industry and academia to provide balanced, practical guidance on how statisticians can apply their knowledge to address real world clinical trial issues.
Background: Clinical Trials. Product Development Process. Regulatory Review Organizations. Clinical Trial Statisticians. Scientific and Practical Issues: General Considerations in Clinical Trial Design. Clinical Trial Designs. Interim Data Monitoring. Analysis Considerations. Analysis of Safety, Benefit:Risk, and Quality of Life. Publishing Trial Results. Appendix. Index.

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