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 14
Protocol Design Part 2: Patient Mix 16
Product Quality: Seals of Approval 16
Protocol Design Part 3: Mixing the Ingredients 17
The Evolution of U.S. Drug Law 20
Costs of Clinical Trials 22
“Breaking the Scientific Bottleneck” 28
Conclusion 32
Chapter 2: Scrounging Your First Study | 33
What Do You Need to Get Started? 33
Navigating Site Selection: Landing Your First Study 34
Newer Methods for Landing a Study 37
Why It’s So Difficult to Get Studies 38
Site Selection: Be Careful What You Wish for-You Might Get It 40
Site Selection: Why a Site Is Chosen, or a Marriage of Convenience 41
Site Qualification Visit, or “Shall We Dance?” 44
Do Size and Setting Matter? 47
Conclusion 49
Chapter 3: Reality Testing: Feasibility, Budgets, and Contracts | 51
Protocol Feasibility 51
Patient Pool 53
Staffing 55
Regulatory Considerations: IRBs 58
Budget Feasibility 58
CROs and SMOs-Dealing with the Middleman 70
Contract Basics 73
The Dark Side of Contracts, or Things Your Mother Never Told You 79
Win-Win Relationships 80
Conclusion 81
Chapter 4: Regulatory Issues | 83
Form FDA 1572 84
IRBs 85
HIPAA 88
Drug Accountability 90
Financial Disclosure 91
Audits 91
How to Prepare for an Audit 96
Conclusion 97
Chapter 5: Study Start-Up | 99
Informed Consent: Safe, Sane, and Consensual 99
Start-Up in Theory 104
Start-Up in Practice: The Paper Trail-Implementing Regulatory Details 105
Initiation Visit 106
Volunteer Recruitment Strategies 107
Advertising 112
Approaching the Patient, or “You Want Me to Do What?” 118
Conclusion 120
Chapter 6: Study Activities: Strategies and Tools | 121
Study Tracking: What Day Is Today? 121
General Tracking Procedures 122
Worksheets, Forms, and Study Folders: Getting in Touch with Your Inner OCD 123
Project Management Techniques 125
Software Programs 126
Coping with Minutiae 126
Drug Storage and Accountability 128
Maintaining Drug and Supply Inventories 129
Monitoring Visits 130
Volunteer Retention and Satisfaction 131
Patient Instructions 133
The Paper Trail Continues 134
Study Closing 140
Conclusion 143
Chapter 7: Ethical Issues in Human Subjects Research | 145
Historical Context 146
Ethical Principles (the Belmont Report) 150
Individual Research Practice: The Nature of the Beast 156
Financial Pressure and Conflict of Interest 157
Patient-Prompted Ethical Issues 162
Adverse Events: Related Ethical Issues 163
IRB-Related Ethical Issues 166
Who’s Minding the Store? A Case Study 167
Conclusion 171
Chapter 8: Society and Politics | 173
Politics of Research: Women 173
Politics of Research: Religion 179
Politics of Research: Race 182
Politics of Research: Race and Gender Overlap 185
Politics of Research: Shifting Studies to Developing Countries 187
Justice and Societal Needs 193
Conclusion 194
Chapter 9: Opportunities and Training in Clinical Research | 195
Enhancing Your Practice 195
Brief Training Options 197
Formal Training Programs 199
Conclusion 201
Epilogue | 203
Appendix A: Background Resource Information | 207
Appendix B: Suggested Resources | 235
Appendix C: Samples, Forms, and Worksheets | 249
Appendix D: Career Information and Training Programs | 339
Notes | 355
Glossary and Acronym Guide | 379
Bibliography | 393
Index | 413
About the Author | 427