Clinical and Translational Science

Clinical and Translational Science

Principles of Human Research

1st Edition - December 15, 2008

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  • Editors: David Robertson, Gordon Williams
  • eBook ISBN: 9780080920191

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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. Clinical and Translational Science 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.

Key Features

  • Clinical research is one of the fastest growing fields in private practice and academic medicine with practical biological, physiological, cellular, and therapeutic applications
  • Contributions from international leaders provide insight into background and future understanding for clinical and translational science
  • Provides the structure for complete instruction and guidance on the subject from fundamental principles, approaches and infrastructure to human genetics, human pharmacology, research in special populations, the societal context of human research, and the future of human research


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

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


Product details

  • No. of pages: 600
  • Language: English
  • Copyright: © Academic Press 2008
  • Published: December 15, 2008
  • Imprint: Academic Press
  • eBook ISBN: 9780080920191

About the Editors

David Robertson

Dr. Robertson graduated from Vanderbilt University in 1969, with a B.A. in Germanic and Slavic Languages. He attended the Arnamagnaen Institute in Copenhagen, Denmark before receiving his medical degree from Vanderbilt University Medical School in 1973. He went on to complete an internship and residency in Medicine at Johns Hopkins Hospital. Robertson was a postdoctoral fellow in Clinical Pharmacology at Vanderbilt for two years before accepting a position as assistant chief of Service in Medicine and instructor in Medicine at Johns Hopkins in 1977.

In 1978, Robertson returned to Vanderbilt as assistant professor of Medicine and Pharmacology, became an associate professor in 1982, then rose to professor in 1986. He spent one year as a visiting professor in the Department of Molecular Endocrinology at National, then served as a visiting professor in the Department of Anatomy and Embryology at University College in London. In 1993, Robertson became director of the Medical Scientist Training Program at Vanderbilt University and also took the position of director of the Division of Movement Disorders in the Department of Neurology, which he held until 2000.

Along with his current roles as professor of Medicine and Pharmacology and professor of Neurology, Robertson is currently the Elton Yates Professor of Autonomic Disorders, director of the General Clinical Research Center and director of the Center for Space Physiology and Medicine for Vanderbilt University.

Robertson currently serves on the Board of Advisors for the World Life Foundation, the NASA Microgravity Human Research Committee, the Merck Advisory Board, and the editorial boards of American Journal of Medicine, Autonomic Neuroscience and Clinical Autnomic Research. He is also associate editor for the Journal of Pharmacology and Experimental Therapeutics.

Affiliations and Expertise

Departments of Medicine, Pharmacology, and Neurology, Clinical Research Center, Vanderbilt University, Nashville, TN, USA

Gordon Williams

Dr. Williams’ group’s first major goal is the identification of the genetic underpinnings of endocrine factors related to cardiovascular (CV) risk in hypertension and diabetes with the ultimate goal of using genetic markers to develop individualized, personal treatment programs for patients with these diseases. His is a translational research group with interdisciplinary focus in humans and at the bench. The group's major focus in human studies is on careful phenotyping of patients with hypertension and diabetes relative to cardiovascular risk factors. The research focuses on evaluating hormones that can modify vascular contractility and/or salt handling. The major current thrusts are the renin-angiotensin-aldosterone system (RAAS), kallikrein, cortisol, adducin, the beta-2 adrenergic receptor and ion transport systems. The second major goal is to determine the role of aldosterone in producing CV disease at molecular, cellular, organ, whole animal and clinical levels. Recent studies suggest that aldosterone has a wide range of effects including inducing microvascular ischemia, thrombosis, fibrosis, and inflammatory responses many of them potentially mediated by aldosterone’s interaction with caveolins and two recently discovered proteins---striatin and lysine specific demethylase 1 (LSD1). Techniques employed include whole animal physiological studies using normal animals, those made hypertensive and those genetically modified (e.g. knock-outs and transgenics). Molecular and cellular techniques include gene arrays using chip technology, proteomics, confocal microscopy, electrophysiology and in situ hybridization. Finally, the group has just begin the first proof of concept clinical trial for using genetic information to provide personalized medicine.

Affiliations and Expertise

Chief, Endocrine Hypertension Division, Brigham and Women's Hospital, Boston, MA, USA

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