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|All Authors / Contributors:||
John I Gallin
|Description:||xv, 490 s. : ill. ; 29 cm.|
|Contents:||Preface. Acknowledgements. Historical Perspective and Introduction. Part I: Ethical, Regulatory and Legal Issues Ethical Principles in Clinical Research. Researching a Bioethical Question. Integrity in Research: Individual and Institutional Responsibility. Institutional Review Boards. Data and Safety Monitoring Boards. Data and Data Management in Clinical Trials. Unanticipated Risk in Clinical Research. The Regulation of Drugs and Biological Products by the Food and Drug Administration. Legal Issues. NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. Part II: Biostatistics and Epidemiology An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size. Design and Conduct of Observational Studies and Clinical Trials. Small Clinical Trials. Large Clinical Trials Clinical Research Institutes. Using Secondary Data in Statistical Analysis. An Introduction to Survival Analysis. Measures of Function and Health Related to Quality of Life. Economic Analysis and Clinical Research. Part III: Technology Transfer, Protocol Development and Funding Overview of Technology Development. Technology Transfer. Telemedicine Systems. Animal Models of Human Disease. Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine. Preparing Scientific Images for Publication and Display. Writing a Clinical Protocol The Mechanics. Navigating the Peer Review Process for Grants.|
|Responsibility:||John I. Gallin|
"...this book clearly fulfills an important function for anyone involved in clinical research...this book will be accessible to a wide range of readers...this book is much needed and provides