Principles and Practice of Clinical Research

Edited By

  • John Gallin, National Institutes of Health, Director, Clinical Center Head, Clinical Pathophysiology Section, Laboratory of Host Defenses,National Institute of Allergy and Infectious Diseases Bethesda, MD


Clinical fellows and clinical researchers.


Book information

  • Published: January 2002
  • ISBN: 978-0-12-274065-7


"...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 essentially all of the basic information required by investigators involved in clinical research, from both a practical perspective and a regulatory is an excellent starting point for those embarking on a clinical research project, as well as a valuable reference that experienced investigators will probably want to have readily available."-THE NEW ENGLAND JOURNAL OF MEDICINE (April 2003) "...a comprehensive treatment of the subject of clinical research...current and asset to a library or personal collection...Dr. John Gallin, Editor, is also an NIH clinical researcher...he and the majority of the 42 contributors are employed by the NIH...therefore, much of the content of this book is in the public domain, an added plus for instructors and students...subject selectors would be interested in all three of the books...however, the work by Dr. Gallin is the most comprehensive of the three...although corporations and universities conduct their own clinical research, they receive funding from or partner with this government agency...this book is recommended for university and hospital can also serve as a textbook for undergraduate and graduate health sciences and science majors...faculty members who engage in clinical research would also benefit from having this volume in their personal collection."-E STREAMS(June 2003) "This book is much needed and provides essentially all of the basic information required by investigators involved in clinical research. important resource for institional libraries and IRBs." ┬┐THE NEW ENGLAND JOURNAL OF MEDICINE "...this volume provides an outstandingly comprehensive introduction to the field and can be recommended for virtually anyone who is interested in clinical research." ┬┐CLINICAL INFECTIOUS DISEASES "Full of practical advice, top tips and the ever useful "Supplemental Reading" section, it even has a sample face sheet and a study design "tick list"." ┬┐IMMUNOLOGY NEWS "...this book will benefit students, researchers, and clinical practitioners in allied health professions. It is recommended for larger academic and health science libraries." ┬┐AMERICAN REFERENCE BOOKS ANNUAL "Suitable for use as a supplementary textbook or reference." ┬┐BOOK NEWS

Table of Contents

A Historical Perspective on Clinical ResearchThe Earliest Clinical ResearchThe Greek and Roman InfluenceMiddle Ages and RenaissanceSeventeenth CenturyEighteenth CenturyNineteenth CenturyTwentieth Century and BeyondPart I: Ethical, Regulatory, and Legal IssuesEthical Principles in Clinical ResearchResearching a Bioethical QuestionIntegrity in Research: Individual and Institutional ResponsibilityInstitutional Review BoardsData and Safety Monitoring BoardsData and Data Management in Clinical Trials. Unanticipated Risk in Clinical ResearchThe Regulation of Drugs and Biological Products by the Food and Drug Administration Legal IssuesNIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical ResearchPart II: Biostatistics and Epidemiology An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample SizeDesign and Conduct of Observational Studies and Clinical TrialsSmall Clinical TrialsLarge Clinical Trials: Clinical Research InstitutesUsing Secondary Data in Statistical AnalysisAn Introduction to Survival AnalysisMeasures of Function and Health Related to Quality of LifeEconomic Analysis and Clinical ResearchPart III: Technology Transfer, Protocol Development and Funding Overview of Technology DevelopmentTechnology TransferTelemedicine SystemsAnimal Models of Human DiseaseConducting and Evaluating Clinical Research on Complementary and Alternative MedicinePreparing Scientific Images for Publication and DisplayWriting a Clinical Protocol: The MechanicsGetting the Funding You Need to Support Your Research: Successfully Navigating the NIH Peer Review Process for Grants