Clinical and Translational Science

Principles of Human Research

Edited by

  • David Robertson, Departments of Medicine, Pharmacology, and Neurology, Clinical Research Center, Vanderbilt University, Nashville, TN, USA
  • Gordon Williams, MD, Chief, Endocrine Hypertension Division, Brigham and Women's Hospital, Boston, MA

Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health.This book is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this resource begins with experimental design and investigative tools to set the scene for readers. It then moves on to human genetics and pharmacology with a focus on statistics, epidemiology, genomic information, drug discovery and development, and clinical trials. Finally, it turns to legal, social, and ethical issues of clinical research concluding with a discussion of future prospects to provide readers with a comprehensive view of the this developing area of science.
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Investigators and clinicians involved in endocrinology, immunology, virology, microbiology, cell biology, pharmacology, and genetics research; post-doctoral fellows and graduate researchers; instructors and trainees in national and international technical clinician and degree programs


Book information

  • Published: December 2008
  • ISBN: 978-0-12-373639-0


Clinical and Translational Science - Principles of Human Research by Robertson and Williams is as much an important textbook as a guide for translational research in the current era. The book covers a whole breadth of topics written by well known authorities which are of practical relevance to the day-to-day conduct of translational research. Given that more and more translational research is being conducted in more and more developing countries, this book would also find relevance for efforts in developing countries. I am sure many will find this a welcome addition to the current array of books on research methodology, clinical trials and clinical epidemiology. This superbly written textbook full of relevant information and refreshing thoughts and ideas (will) be appreciated by students and teachers of medicine, clinical researchers and policy makers.

Khalid Yusoff
Professor of Medicine and Dean Faculty of Medicine
Universiti Teknology MARA
Shah Alam, Malaysia

Table of Contents

List of Contributors



Introduction to Clinical Research

Part I Fundamental Principles

1 Patient-Oriented Research: Clinical Pathophysiology and Clinical Therapeutics

2 Clinical Trials

Part II Approaches

3 Experimental Design

4 Introduction to Biostatistics Ideas

5 Measurement of Biological Materials

6 Imaging Tools in Human Research

7 Imaging Tools in Cardiovascular Research

8 Nanotechnology in Clinical and Translational Research

9 The Use of Questionnaires and Surveys

10 Information Technology

Part III Infrastructure

11 Clinical and Translational Science Infrastructure

12 Industry-Sponsored Clinical Research in Academia

Part IV Education, Training and Career Choices

13 Training Basic, Clinical and Translational Investigators

14 A Stepwise Approach to a Career in Translational Research

15 Physician Careers in Industry

Part V Funding

16 Governmental Support of Research

17 Support of Health Research by Private Philanthropy

18 Pharmaceutical and Biotechnology Sector Support of Research

Part VI Human Genetics

19 Introduction to Human Genetics

20 Epidemiologic and Population Genetic Studies

21 Pharmacogenetics of Drug Metabolism

Part VII Human Pharmacology

22 Introduction to Clinical Pharmacology

23 Toxicology and Genetics of Adverse Drug Events

24 Good Clinical Practice and Good Laboratory Practice

25 Modern Drug Discovery and Development

Part VIII Societal Context of Human Research

26 Translating Science to the Bedside: The Innovation Pipeline

27 Regulatory Environment

28 Ethical Issues in Translational Research and Clinical Investigation

29 Clinical Research in the Public Eye

Part IX Research in Special Populations

30 Acute Illnesses, Critical Care, Emergency and Surgical Patients

31 Psychiatric Disorders

32 Geriatrics

33 Pediatrics

Part X Population-Based Research

34 Pharmacoeconomics: The Economic Evaluation of New Medical Technology

35 Introduction to Epidemiology

36 Health Services Research: Translating Discovery and Research into Practice and Policy

Part XI Prospectus

37 The Future of Clinical Research