Clinical and Translational Science Principles of Human Research 2nd Edition by David Robertson, Gordon H Williams ISBN 9780128021118 012802111X

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ISBN 10: 012802111X
ISBN 13: 9780128021118
Author: David Robertson, Gordon H Williams

Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health.

This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science.

• Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine
• Brings insights from international leaders into the discipline of clinical and translational science
• Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

Clinical and Translational Science Principles of Human Research 2nd Edition Table of contents:

Section I. Fundamental Principles

Chapter 1. Introduction to Clinical Research

Historical Background

Organization of This Book

Note

Chapter 2. Patient-Oriented Research

Introduction

Types of Patient-Oriented Research

The Role of Patient-Oriented Research in Translational Research

The Role of the Patient in Patient-Oriented Research

Sequence of Investigation

Tools of the Patient-Oriented Researcher

Funding for Patient-Oriented Research

Conclusions

Chapter 3. Clinical Trials

Introduction

History

Phases of Evaluation of Therapies

Critical General Concepts

Expressing Clinical Trial Results

Concepts Underlying Trial Design

General Design Considerations

Legal and Ethical Issues

Hypothesis Formulation

Publication Bias

Statistical Considerations

Metaanalysis and Systematic Overviews

Understanding Covariates and Subgroups

Therapeutic Truisms

Study Organization

Integration Into Practice

The Future

Chapter 4. Introduction to Epidemiology

Introduction: Definition and Role of Epidemiology

Measuring Occurrence of Disease

Measuring Risk and Association

Types of Epidemiological Studies

Threats to Validity and Reliability

Moving From Association to Causation

Clinical Epidemiology

Sex, Gender, Race, and Ethnicity in Epidemiology

Conclusion

Chapter 5. The Patient-Centered Outcomes Research Institute: Current Approach to Funding Clinical Research and Future Directions

Introduction: The Patient-Centered Outcomes Research Institute

Patient-Centered Comparative Effectiveness Research

Patient and Stakeholder Engagement in Research

Methodology Standards for Patient-Centered Comparative Effectiveness Research

Pragmatic Research

Integrating Research Into the Learning Health-Care System

Conclusion: Vision of Clinical Research in the 21st Century

Glossary

List of Acronyms and Abbreviations

Chapter 6. Health-Care Technology Assessment (HTA)

Summary

Introduction

The Evaluation of New Medical Technology: The Producer’s Perspective

The Evaluation of New Medical Technology: The End User’s Perspective

The Evaluation of New Medical Technology: Society’s Perspective

Cost–Benefit, Cost-Effectiveness, and Cost–Utility Analysis

Can One Ever Avoid Putting Monetary Values on Health Benefits?

Unresolved Controversies on Economic Valuations in Health Care

Chapter 7. Health Services Research: Translating Discovery and Research Into Practice and Policy

Introduction

What Is Health Services Research and What Are Its Goals?

Assessing Medical Interventions: Outcomes, Effectiveness, and Cost-Effectiveness

Conclusions

Section II. Approaches

Chapter 8. Measurement of Biological Materials

Introduction

Immunoassays and Immunochemistry

Mass Spectrometry and Chromatography

Genomics

Proteomics, Lipidomics, Metabolomics, and Multiomics

Conclusion

Chapter 9. Imaging Tools in Clinical Research: Focus on Imaging Technologies

Introduction

Imaging Technologies

Conclusion

Chapter 10. Imaging Tools in Human Research: Focus on Image-Guided Intervention

Introduction

Image-Guided Biopsy

Image-Guided Therapy

Conclusion

Chapter 11. Nanotechnology in Clinical and Translational Research

Introduction and Historical Perspective

Nanotechnology in Basic Research Applications Supporting Clinical Translation

Clinical Applications of Nanotechnology for Research

Conclusion and Future Directions in Nanomedicine

Chapter 12. The Use of Questionnaires and Surveys

Introduction

The Practice of Questionnaire and Survey Measurement

Statistical and Analysis Considerations

Summary and Conclusions

Glossary

List of Acronyms and Abbreviations

Chapter 13. Information Technology

Introduction

Clinical Data Repositories

Information Technology Support of Participant Recruitment

Principles of Data Collection

Data Standards

Clinical Trial Management Systems

Publicly Available Databases

The Growing Impact of Big Data and the Cloud

Conclusion

Chapter 14. Principles of Biostatistics

Introduction

Types of Data

Descriptive Statistics

Testing and Summarizing Relationship Between Two Variables

Baseline Comparisons and Primary Outcome Analysis

Generalized Linear Models

Model Building

Multiple Comparisons

Missing Data

Linear Mixed-Effects Models (Clustered or Longitudinal Studies)

Conclusion

Chapter 15. Good Clinical Practice and Good Laboratory Practice

Overview

Good Clinical Practice

Good Laboratory Practice

Glossary

List of Acronyms and Abbreviations

Section III. Human Genetics

Chapter 16. Introduction to Human Genetics

Introduction

Basic Molecular Genetics

Patterns of Genetic Transmission

Cytogenetics and Chromosomal Disorders

The Human Genome

Genetic Variation

Medical Applications

Genetic Counseling

Phenotyping and Clinical Research

Conclusion

Chapter 17. Epidemiologic and Population Genetic Studies

Introduction

Design Issues in Genetic Association Studies

Epidemiologic Study Design

Genetic Study Design: Genome-Wide Association Study Versus Hypothesis-Driven (Candidate Gene) Approaches

Interpreting Results of Genetic Association Studies

Future Directions

Conclusion

Chapter 18. Pharmacogenetics of Drug Metabolism

Introduction

Pharmacogenetics of Drug Metabolism: Historical Aspects

Genetic Polymorphisms of Individual Drug-Metabolizing Genes

CYP2B6

CYP2C8

CYP2C9

CYP2C19

CYP2D6

CYP3A5

N-acetyltransferase 2

Thiopurine Methyltransferase

UDP-Glucuronosyltransferase

Butyrylcholinesterase

Conclusions

Chapter 19. Statistical Techniques for Genetic Analysis

Introduction

Genetic Determination of Complex Disease

Genetic Linkage Studies

Common Genetic Study Designs and Statistical Tests

Genomewide Association Studies

Next-Generation Sequencing

Metaanalysis Techniques

Gene-by-Environment Analysis

Multivariant Approaches

Network Medicine

Integrative Omics

Phenotypic Limitations

Computer Programs

Summary and Conclusions

Glossary

List of Acronyms and Abbreviations

Section IV. Human Pharmacology

Chapter 20. Introduction to Clinical Pharmacology

Introduction: Mechanisms of Drug Disposition and Interactions

Transporters and Drug Absorption, Distribution, and Excretion

Drug-Metabolizing Enzymes

Drug–Drug Interactions

Induction and Regulation of Drug-Metabolizing Enzymes and Transporters

Principles of Pharmacokinetics

Conclusion

Chapter 21. Adverse Drug Events

The Multifactorial Nature of Adverse Drug Events

Types of Adverse Drug Events

Genetics to Genomics

Section V. Societal Context of Human Research

Chapter 22. Translating Science to the Bedside: The Innovation Pipeline

Realities of the Marketplace

Ideas and Innovations

Working With Industry

Entrepreneurship

Clinical Evaluation of Innovative Products

Conflicts of Interest

Translating Science to the Bedside Cores in Academic Health Centers

Summary

Statutes and Federal Regulations

Cases

Chapter 23. Regulatory Environment

Introduction

The US Food and Drug Administration

Other Regulatory Agencies

Conclusions

Glossary

List of Acronyms and Abbreviations

Chapter 24. Ethical Issues in Translational Research and Clinical Investigation

Introduction

Responsibility in Science and Society

Ethics and Translational Research

Guiding Principles for the Responsible Translational Investigator

Justice, Beneficence, and Respect for Persons: From Principles to Practice

Regulation of Research and Protection of Subjects

Individuals and the Clinical Research Process

Professionalism in Clinical Research

Chapter 25. Clinical Research in the Public Eye

Introduction

The Cultural Context of Research

Science and Politics

Conclusion

Section VI. Research in Special Populations

Chapter 26. Research in Special Populations: Acute Illnesses; Critical Care; and Surgical Patients

Introduction

Trial Design

Usual Care in Critically Ill Patients

Informed Consent

Outcomes

Adverse Events

Conclusion

Chapter 27. Research in the Emergency Care Environment

Introduction

The Environment and Unique Challenges of Emergency Care Research

Examples of Early Success

Building an Emergency Care Research Site

Funding of Infrastructure in the Emergency Care Environment

The Role of Industry

Implementation of Emergency Care Research

Conclusion

Chapter 28. Psychiatric Disorders

Introduction

Diagnostic Issues

Types of Studies

Tools

Statistical and Design Issues

Special Issues

A Practical Schematic Approach

Summary

Chapter 29. Research in Special Populations: Geriatrics

Introduction

What Is Different About Aging Research?

How an Aging Perspective Affects Research Topics and Approaches

The Effect of Aging on the Pragmatics of Research

Conclusions and Recommendations

Chapter 30. Clinical Research in Neurology

Introduction

Features Unique to Neurologic Diseases

Disease Examples

Conclusion

Chapter 31. Research in Pediatrics

Introduction

What Is Different About Pediatric Research?

Orphan (Rare) Diseases

Pediatric Conditions as Focus of Inquiry

Regulatory and Ethical Environment for Pediatric Research

Conclusion

Statutes and Regulations

Cases

Chapter 32. Cancer as a Paradigm for Translational and Clinical Biomedical Research

Introduction

Cancer: From the Edwin Smith Papyrus to the Molecular Genetic Era

Cancer Drivers and Personalized Medicine

From the Bench to the Bedside

The Crusade to Overcome Drug Resistance in Cancer

List of Acronyms and Abbreviations

Chapter 33. Maintaining an Emphasis on Rare Diseases With Research Initiatives and Resources at the National Center for Advancing Translational Sciences

Introduction

Translational Science Spectrum

Definition of Rare Diseases

International Classification of Diseases

Evolving Approaches to Rare Diseases Research

Translational Research Efforts and Resources at NCATS and Other NIH Institutes

The Rare Diseases Clinical Research Network Program—A Model for Collaboration

Rare Diseases Research and Orphan Product Development

RDCRN and Clinical and Translational Science Awards Programs on Education and Training Resources

Assessment of Unmet Medical Device Needs for Rare Diseases

An Even Brighter Path Forward

Section VII. Infrastructure

Chapter 34. Clinical and Translational Science Infrastructure

Introduction

Reinventing the Clinical Research Infrastructure

Clinical and Translational Science Institutes

National Center for Advancing Translational Sciences

Human Genome Project

Clinical and Translational Science Award

Conclusion

Section VIII. Education, Training and Career Choices

Chapter 35. Education, Training and Career Choices: Training Basic, Clinical, and Translational Investigators

Introduction

Overview

Didactic Curriculum

Degree-Granting Programs in Clinical or Translational Research

The Mentored Research Experience

Career Development Resources

Funding for Training Clinical and Translational Investigators

Chapter 36. A Stepwise Approach to a Career in Translational Research

Definitional Issues

Historical Perspective

Step 1: The Starting Point

Step 2: The Need for Normative Data and Control Populations

Step 3: Engaging Relevant Basic Researchers and Their Technologies

Step 4: Identifying Tractable Problems

Step 5: Identifying Appropriate Mentors Across a Career

Step 6: Obtaining Successful Independent Funding

Step 7: The Perils of Senior Leadership

Summary

Chapter 37. Physician Careers in the Pharmaceutical Industry

Introduction

Medical-Scientific Positions in the Pharmaceutical Industry

A Pharmaceutical Career

Summary

Section IX. Research in Academia

Chapter 38. Industry-Sponsored Clinical Research in Academia

Introduction

The Public Perspective

The Academic Health Center Perspective

The Industry Perspective

The Investigators’ Perspective

Matching Industry Needs and Academic Health Center Priorities

Conclusion

Chapter 39. Governmental Support of Research

Introduction

Overview

United States Government Scientific Programs

Scientific Programs in Europe, Canada, and Australia/New Zealand

Scientific Programs in Asia, Africa and South/Central America and the Caribbean

Current Support for Clinical and Translational Research

Conclusion

Chapter 40. The Role of Nonprofit, Nongovernmental Funding in Support of Biomedical Research

Introduction

Overview of Philanthropic Funding on Biomedical Research

Distinctions Between Different Types of Philanthropic Funders

Funding Type

Recipient Type

Foundations Attached to Government Agencies

Concepts in Nonprofit Funding

Conclusion

Problem Set

Chapter 41. Modern Drug Discovery and Development

Introduction

The Origins of Drug Discovery

Drug Discovery in the 21st Century

Preclinical Development

Clinical Development

New Drug Discovery Paradigms

Conclusion

Chapter 42. Pharmaceutical and Biotechnology Sector Support of Research

Introduction

The Drug Development Process

Basic Science Within the Pharmaceutical and Biotechnology Sectors

Developmental Research—A Contrast to Academia and Government

Clinical Research and Development

Marketed Product Research

Conclusion

Section X. Prospectus

Chapter 43. The Future of Clinical Research

Definition of Translational Human Research

Subgrouping of Biological Scientists

The Patient-Oriented Scientist at the Beginning of the 21st Century

The 21st Century and the Future

Novel New Approaches: Big Data and N-of-One

Summary

Index

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Tags: David Robertson, Gordon H Williams, Translational Science, Human Research