Principles and practice of clinical research

"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 tra...

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Bibliographic Details
Other Authors: Gallin, John I. (Editor)
Format: Book
Language:English
Published: San Diego, CA Academic Press 2002
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Table of 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
  • Design and conduct of observation studies and clinical trials / Teri A. Manolio
  • Small clinical trials / Mitchell B. Max
  • Large clinical trials: clinical research institutes / Robert M. Califf
  • Using secondary data in statistical analysis / Bradley D. Freeman, Eric P. Gerstenberger, Steven Banks, and Charles Natanson
  • An introduction to survival analysis / Joanna H. Shih
  • Measures of function and health-related quality of life / Lynn H. Gerber
  • Economic analysis and clinical research / Martin L. Brown, Keven B. Knopf, Stephen E. Marcus, and Joseph Lipscomb
  • Overview of technology development / Bruce Goldstein
  • Technology transfer / James Clifford Haight
  • Telemedicine systems / Kenneth M. Kempner, Frank S. Govern, and Robert Martino
  • Animal models of human disease / Domenico Accili
  • Conducting and evaluating clinical research on complementary and alternative medicine / Wayne B. Jonas and Klaus Linde
  • Preparing scientific images for publication and display / Christopher Vargas
  • Writing a clinical protocol: the mechanics / Eddie Reed and Antoinette Jones-Wells
  • Getting the funding you need to support your research: successfully navigating the NIH peer review process for grants / Olivia T. Preble Bartlett and Elliot Postow.