Clinical and Translational Science: Principles of Human Research

by David Robertson (Editor), Gordon H. Williams MD (Editor)

Overview

This is the definitive text introducing the new discipline of clinical and translational science. It covers all aspects of this new field, and captures the excitement of novel approaches to investigation of human health and disease, emphasizing drug discovery, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health.

This book begins with experimental design and investigative tools. It moves on to human genetics and pharmacology with a focus on genomic science, clinical trials, epidemiology, outcomes, research, drug discovery and development, and clinical trials. It addresses legal, social and ethical issues of clinical research.

* Discusses practical biological, physiological, cellular, and therapeutic applications for one of the fastest growing fields in private practice and academic medicine

* Includes contributions from international leaders providing insight into background and future understanding for clinical and translational science

* Presents 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

Product Details

ISBN-13:	9780080920191
Publisher:	Elsevier Science & Technology Books
Publication date:	03/02/2009
Sold by:	Barnes & Noble
Format:	eBook
Pages:	600
File size:	9 MB

About the Author

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.

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.

Table of Contents

Section I. Fundamental Principles
1. Introduction to Clinical Research
2. Patient-Oriented Research
3. Clinical Trials
4. Introduction to Epidemiology
5. The Patient-Centered Outcomes Research Institute: Current Approach to Funding Clinical Research and Future Directions
6. Health-Care Technology Assessment (HTA)
7. Health Services Research: Translating Discovery and Research Into Practice and Policy

Section II. Approaches
8. Measurement of Biological Materials
9. Imaging Tools in Clinical Research: Focus on Imaging Technologies
10. Imaging Tools in Human Research: Focus on Image-Guided Intervention
11. Nanotechnology in Clinical and Translational Research
12. The Use of Questionnaires and Surveys
13. Information Technology
14. Principles of Biostatistics
15. Good Clinical Practice and Good Laboratory Practice

Section III. Human Genetics
16. Introduction to Human Genetics
17. Epidemiologic and Population Genetic Studies
18. Pharmacogenetics of Drug Metabolism
19. Statistical Techniques for Genetic Analysis

Section IV. Human Pharmacology
20. Introduction to Clinical Pharmacology
21. Adverse Drug Events

Section V. Societal Context of Human Research
22. Translating Science to the Bedside: The Innovation Pipeline
23. Regulatory Environment
24. Ethical Issues in Translational Research and Clinical Investigation
25. Clinical Research in the Public Eye

Section VI. Research in Special Populations
26. Research in Special Populations: Acute Illnesses; Critical Care; and Surgical Patients
27. Research in the Emergency Care Environment
28. Psychiatric Disorders
29. Research in Special Populations: Geriatrics
30. Clinical Research in Neurology
31. Research in Pediatrics
32. Cancer as a Paradigm for Translational and Clinical Biomedical Research
33. Maintaining an Emphasis on Rare Diseases With Research Initiatives and Resources at the National Center for Advancing Translational Sciences

Section VII. Infrastructure
34. Clinical and Translational Science Infrastructure

Section VIII. Education, Training and Career Choices
35. Education, Training and Career Choices: Training Basic, Clinical, and Translational Investigators
36. A Stepwise Approach to a Career in Translational Research
37. Physician Careers in the Pharmaceutical Industry

Section IX. Research in Academia
38. Industry-Sponsored Clinical Research in Academia
39. Governmental Support of Research
40. The Role of Nonprofit, Nongovernmental Funding in Support of Biomedical Research
41. Modern Drug Discovery and Development
42. Pharmaceutical and Biotechnology Sector Support of Research

Section X. Prospectus
43. The Future of Clinical Research

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From the Publisher

As the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, this resource provides critical access to new molecular tools and diagnostic technologies to help users gain a better understanding of human disease and the development of new therapeutics for enhanced health