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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

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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

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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

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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 Your Mother Never Told You 109

Win-Win Relationships 110

Conclusion 112

Chapter 4: Regulatory Issues | 113

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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

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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

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

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Software Programs 189

Coping with Minutiae 190

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

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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

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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 Uses 279

Unanticipated Risk in Clinical Trials Uses 281

Who's Minding the Store? A Case Study 286

Conclusion 290

Chapter 9: Society and Politics | 293

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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

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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

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Appendix C: Career Information and Training Programs | 401

Notes | 443

Glossary and Acronym Guide | 511

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Bibliography | 525

Index | 579

About the Author | 601