Clinical and Translational Science

1st Edition

Principles of Human Research

Editors: David Robertson Gordon Williams
Paperback ISBN: 9780123736390
eBook ISBN: 9780080920191
Imprint: Academic Press
Published Date: 15th December 2008
Page Count: 600
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Description

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.

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

Readership

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 Foreword Acknowledgments 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

Details

No. of pages:
600
Language:
English
Copyright:
© Academic Press 2009
Published:
Imprint:
Academic Press
eBook ISBN:
9780080920191
Paperback ISBN:
9780123736390

About the Editor

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

Reviews

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.