Hardly a week goes by without a newspaper headline or an evening news report detailing a mishap or scandal in the world of clinical research. An increasingly informed public demands speedy breakthroughs in treatment while eyeing warily the risks of participation in clinical trials. The nation’s most prestigious medical centers suffer record fines for research misconduct and the embarrassment that goes with it. Against this backdrop those in the trenches of clinical research work under heightening pressure and scrutiny. More than ever this field demands an unprecedented level of knowledge and understanding.

Clinical Research: What It Is and How It Works will provide you with a fundamental yet comprehensive understanding of all phases of the clinical research process. Every aspect of clinical research from program design, regulatory issues, ethical considerations, to IRB roles and functions, quality controls, financial management, and more are explained in clear, concise language. Whether you are a seasoned researcher or a brand new member of an IRB, this book will provide a clear, thorough perspective on the clinical research process.

• Covers important regulatory issues that have been established for conducting and monitoring clinical research.

• Provides a who's-who of the vast clinical trial industry from innovators, contract research organizations, site management organizations, and clinical trial sites, to sponsors, research participants, clinical research coordinators, and clinical research associates.

• Provides valuable industry definitions and insights.

Preface
Acknowlegements

Chapter 1: Testing Treatments in Humans
Karen L. Pellegrin, PhD, MBA
Lori A. Nesbitt, PharmD, MBA

Testing Drugs in Humans
Clinical Research--Not an Exact Science
Study Design
Elements of the Clinical Trial Protocol
Case Study: Evaluating the Protocol
Best Practices
Key Questions
References

Chapter 2: Bioethics and Human Advocacy
Daphne J. Childers, CCRC, CIM
Karen L. Pellegrin, PhD, MBA

The Evolution of Ethical Principles of Clinical Research
How the Ingestigator Applies Ethical Principles
Role of the Institutional Review Board
Why Do Investigators Need to Know about IRBs?
What IRB Members Should Know about Clinical Research
Risks Versus Benefit Analysis--The Human Advocate
Continuing Review and Monitoring of Data
Informed Consent--Not Just a Document
What the Site Should Kow About the IRB Process
Ethical Dilemmas in Clinical Research
Best Practices
Key Questions
References

Chapter 3: The Clinical Research Industry
Lori A. Nesbitt, PharmD, MBA

Clinical Trial Service Providers
Industry Trade Organizations and Support Devices
New Technologies for Discovery
Summary
Best Practices
Key Questions
References

Chapter 4: Clinical Trial Implementation
Lori A. Nesbitt, PharmD, MBA

Evaluating the Clinical Trial Protocol
Initiating the Clinical Trial Protocol
Executing the Clinical Trial Protocol
Summary
Best Practices
Key Questions
References

Chapter 5: Data Management
Karen L. Pellegrin, PhD, MBA

The Role of the Sponsor/CRO
The Role of the Investigative Site
Best Practices
Key Questions

Chapter 6: Quality Management and FDA Readiness
Karen L. Pellegrin, PhD, MBA

Quality Management
Creating a Culture of Quality
Ensuring FDA Readiness
Preparing for an Audit
Case Study: An FDA Audit
Best Practices
Key Questions
References

Chapter 7: The Research Participant
Eileen Myers, RD, MPH
Lori A. Nesbitt, PharmD, MBA

Vignette: The Skeptic
Vignette: The Pleaser
Vignette: The Information Seeker
Vignette: The Hopeless
Vignette: The Money Seeker
Vignette: The Professional Research Participant
Vignette: The High-Maintenance Participant
Vignette: The Noncompliant Participant
Summary
Best Practices
Key Questions

Chapter 8: The Business of Clinical Research
Ted Schmidt, RPh
Lori A. Nesbitt, PharmD, MBA

Evaluating and Negotiating Study Budgets
Contracting with Sponsors, CROs, and Service Providers
Funding Needs
Managing Cash Flow
Case Study: Managing the Growth
Best Practices
Key Questions

Chapter 9: The Clinical Research Site
Lori A. Nesbitt, PharmD, MBA

Prophet or Profit: Commitment and Motivation
Clinical Trial Core Competencies
Industry Affiliations
Key Clinical Research Personnel
Investigator and Research Personnel Training
Standard Operating Procedures
Humble Beginnings
Marketing Research Services
Best Practices
Key Questions