Title: Principles and practice of clinical research /
Authors: Gallin, John I.
Publisher: Academic Press,
Year: 2002
Subjects: Clinical medicine Research; Biomedical Research methods; Research Design
Abstract: Publisher Description (unedited publisher data) Counter Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues biostatistics and epidemiology technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research. Key Features * Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology * Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display * Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH * Excellent companion text for courses on clinical research.
Contents: A historical perspective on clinical research / John I. Gallin -- Ethical principles in clinical research / Christine Grady -- Researching n bioethical question / Ezekiel J. Emanuel -- Integrity in research: individual and institutional responsibility / Alan N. Schechter -- Institutional review boards / Alison Wichman and Alan L. Sandler -- Data and safety monitoring boards / Lawrence M. Friedman -- Data and clinical management clinical trials / Jane Cassidy -- Unanticipated risk in clinical research / Stephen E. Straus -- The regulation of drugs and biological products by the Food and Drug Administration / Kathryn C. Zoon and Robert A. Yetter -- Legal issues / Patricia A. Kvochak -- NIH policy on the inclusion of women and minorities as subjects of clinical research / Eugene G. Hayunga and Vivian W. Pinn -- An introduction to biostatistics: randomizations, hypothesis testing, and sample size / Paul S. Albert and Craig B. Borkowf --^