Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators / Edition 2

by Judy Stone

Overview

What's the best way to get started in clinical trials? How do I recruit volunteers? How do I traverse the ethical and political issues involved in conducting drug trials today? With the tremendous demand for clinical investigators—thousands of new investigators are needed in the United States alone—the answers to these questions is vital. Dr. Judy Stone answers these questions and more in this experienced and successful first-hand "view from the trenches." The book reveals the minefields and booby traps to avoid when entering this field, summarizes the drug development process, describes the complexities of the multiple disciplines and people that need to come together to successfully bring a drug through trial, FDA approval and to market. The book details the best practices involved in carrying out a study from landing your first study and negotiating with a drug company to recruiting and treating volunteers. Other topics include new regulations affecting research, subject injury clauses, legal and publication land mines, the unique needs of device and vaccine trials, cultural competency and health literacy, the impact of HIPAA on U.S. research, and how to survive audits. "Successfully covers . . . clinical trials. Practical considerations . . . substantial background and resource information . . . fills an important need." Annals of Internal Medicine

Product Details

ISBN-13:	9780974917818
Publisher:	Mountainside MD Press
Publication date:	08/28/2010
Series:	Conducting Clinical Research: A Practical Guide for Physicians,
Pages:	601
Product dimensions:	7.00(w) x 10.00(h) x 1.70(d)

About the Author

Judy Stone, MD, is an internist and infectious disease specialist. She is Board Certified in Internal Medicine and a sought-after speaker on the topics of antibiotics, infectious diseases, and clinical trials. She is also a frequent contributor to the "Second Opinions" column at Clinical Trials Networks Best Practices.

Table of Contents

Preface ix

How Not to Kill the Patient-or the Investigator ix

Why Read This Book? A View from the Trenches ix

Acknowledgments xiii

Introduction xv

Chapter 1 Overview 3

Why do Studies? 3

Liability? 4

Jargon 5

Who's Who 5

Study Activities 10

Phases of Drug Development 10

Protocol Design Part 1: Parts of a Protocol 16

Protocol Design Part 2: Patient Mix 18

Product Quality: Seals of Approval 19

Protocol Design Part 3: Mixing the Ingredients 20

Medical Device Trials 22

Vaccines and Other Biologics 28

The Evolution of U.S. Drug Law 38

Problems with Antibiotics 41

Conclusion 43

Chapter 2 Scrounging Your First Study 45

What do You Need to Get Started? 45

Navigating Site Selection: Landing your First Study 48

Newer Methods for Landing a Study 49

Why It's so Difficult to Get Studies 53

Site Selection: Be Careful What you Wish for-you Might Get it 55

Site Selection: Why a Site is Chosen, or a Marriage of Convenience 57

Site Qualification Visit, or "Shall we Dance?" 59

Do Size and Setting Matter? 62

Conclusion 65

Chapter 3 Reality Testing: Feasibility, Budgets, and Contracts 67

Feasibility Overview 67

Protocol Feasibility 68

Patient Pool 72

Staffing 73

Regulatory Considerations: IRBs 76

Managing the IRB Submission Process 78

Regulatory Considerations: Billing for Clinical Trials 80

Antikickback, False Claims, and Stark Laws 82

Budget Feasibility 83

CROs and SMOs-Dealing with the Middleman 97

Contract Basics 100

The Dark Side of Contracts, or Things you Mother Never Told you 109

Win-Win Relationships 110

Conclusion 112

Chapter 4 Regulatory Issues 113

New Regulations 115

Form FDA 1572-What are you Really Signing? 121

IRBs 123

HIPAA 125

Drug Accountability 129

Financial Disclosure, or Whose Business is it Anyway? 130

Audits 132

How to Prepare for an Audit 143

Conclusion 145

Chapter 5 Study Start-Up 147

Informed Consent: Safe, Sane, and Consensual 147

Start-Up in Theory 157

Start-Up in Practice: The Paper Trail-Implementing Regulatory Details 159

Initiation Visit 160

Electronic Medical Records 161

Volunteer Recruitment Strategies 164

Advertising 170

Web Advertising and Social Networking 175

Approaching the Patient, or "you Want me to do What?" 178

Conclusion 180

Chapter 6 Study Activities: Strategies and Tools 181

SOPS-Why Bother? 181

Study Tracking: What Day is Today? 185

General Tracking Procedures 185

Worksheets, Forms, and Study Folders: Getting in Touch with your Inner OCD 186

Project Management Techniques 189

Software Programs 189

Coping with Minutiae 190

Billing Compliance-Practicalities 191

Drug Storage and Accountability 192

Maintaining Drug and Supply Inventories 193

Monitoring Visits 194

Volunteer Retention and Satisfaction 195

Patient Instructions 198

The Paper Trail Continues 202

Study Closing 213

Conclusion 216

Chapter 7 Perspective on the State of the Industry 217

Costs of Clinical Trials 217

"Breaking the Scientific Bottleneck" 225

Where have all the Trials Gone? 237

Overseas Drug Manufacturing 241

Conclusion 242

Chapter 8 Ethical Issues in Human Subjects Research 243

Historical Context 244

Ethical Principles (the Belmont Report) 248

Special Populations 255

Individual Research Practice: The Nature of the Beast 258

Financial Pressure and Conflict of Interest 258

Whose Body is it? Tissue Ownership 265

Patient-Prompted Ethical Issues 270

Adverse Events: Related Ethical Issues 271

Publication Ethics 275

Practice Guidelines 277

Off-Label Uses 278

IRB-Related Ethical Issues 279

Unanticipated Risk in Clinical Trials 281

Who's Minding the Store? A Case Study 286

Conclusion 290

Chapter 9 Society and Politics 293

Politics of Research: The FDA 293

Politics of Research: Women 300

Politics of Research: Religion 307

Politics of Research: Race 311

Politics of Research: Race and Gender Overlap 313

Politics of Research: Shifting Studies to Developing Countries 315

Justice and Societal Needs 324

Conclusion 336

Chapter 10 Opportunities and Training in Clinical Research 337

Enhancing your Practice 338

Brief Training Options 339

Formal Training Programs 341

Conclusion 344

Epilogue 345

Appendix A Background Resource Information 349

Appendix B Suggested Resources 387

Appendix C Career Information and Training Programs 401

Notes 443

Glossary and Acronym Guide 511

Bibliography 525

Index 579

About the Author 601

What People are Saying About This

Steven M. Opal

"A truly useful guide . . . thoughtfully organized . . . highly informative . . . of great value to clinical investigators along with study nurses and, most importantly, clinical research coordinators . . . fills a gap in clinical research knowledge."--(Steven M. Opal, MD, Professor of Medicine, Brown Medical School, Chief, Infectious Disease Division, Memorial Hospital of Rhode Island)

Robert Moellering

A valuable guide for practicing physicians interested in becoming involved in clinical trials, written by a talented physician investigator. (Robert Moellering, MD, Professor of Medicine, Harvard Medical School, Physician-in-Chief and Chairman of the Department of Medicine, Beth Israel Deaconess Medical Center)

Henry Masur

A readable, insightful overview of research conduct for healthcare workers. (Henry Masur, MD, Chief, Critical Care Medicine, Clinical Center, National Institutes of Health)

Kari Anderson

"Dr. Stone's book provides an educational foundation for the novice researcher and is a necessary reference for all clinical research personnel . . . a 'must read' for all study coordinators, research nurses, and investigators."--(Kari Anderson, EdD, MSN, RN, clinical scientist, former assistant professor at UNCW School of Nursing)

Editorial Reviews

Successfully covers . . . clinical trials. Practical considerations, substantial background and resource information. The text is well written . . .fills an important need.

Annals of Internal Medicine

Reviewer: Diane M Tomasic, EdD, RN (Slippery Rock University )
Description: This book provides the essential information for conducting clinical research.
Purpose: The author approaches the topic from experiences in clinical research.
Audience: The target audience is primarily physicians involved in clinical research, but the book is also appropriate for study coordinators, research nurses, and investigators engaged in clinical research. It can be a foundation for novice researchers. The author has over 20 years of experience conducting clinical trials.
Features: The book covers the essentials of conducting clinical research from protocol design to ethical issues. Throughout, the author shares personal experiences in a feature called "View from the trenches" that alerts readers to pitfalls. The book is written in a conversational style that is easy to read. Important points are bulleted. Appendixes include resources for clinical research, samples, forms, worksheets, and career information and training programs. An icon marks elements for patient safety.
Assessment: This is a must have for novice or experienced clinical researchers. This book approaches the topic from the experiential perspective, pointing out problems that may be encountered.

Doody's Review Service