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| Preface | |
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| How Not to Kill the Patient-or the Investigator | |
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| Why Read This Book? A View from the Trenches | |
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| Acknowledgments | |
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| Introduction | |
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| Overview | |
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| Why do Studies? | |
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| Liability? | |
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| Jargon | |
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| Who's Who | |
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| Study Activities | |
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| Phases of Drug Development | |
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| Protocol Design Part 1: Parts of a Protocol | |
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| Protocol Design Part 2: Patient Mix | |
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| Product Quality: Seals of Approval | |
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| Protocol Design Part 3: Mixing the Ingredients | |
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| Medical Device Trials | |
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| Vaccines and Other Biologics | |
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| The Evolution of U.S. Drug Law | |
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| Problems with Antibiotics | |
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| Conclusion | |
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| Scrounging Your First Study | |
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| What do You Need to Get Started? | |
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| Navigating Site Selection: Landing your First Study | |
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| Newer Methods for Landing a Study | |
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| Why It's so Difficult to Get Studies | |
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| Site Selection: Be Careful What you Wish for-you Might Get it | |
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| Site Selection: Why a Site is Chosen, or a Marriage of Convenience | |
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| Site Qualification Visit, or "Shall we Dance?" | |
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| Do Size and Setting Matter? | |
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| Conclusion | |
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| Reality Testing: Feasibility, Budgets, and Contracts | |
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| Feasibility Overview | |
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| Protocol Feasibility | |
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| Patient Pool | |
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| Staffing | |
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| Regulatory Considerations: IRBs | |
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| Managing the IRB Submission Process | |
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| Regulatory Considerations: Billing for Clinical Trials | |
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| Antikickback, False Claims, and Stark Laws | |
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| Budget Feasibility | |
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| CROs and SMOs-Dealing with the Middleman | |
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| Contract Basics | |
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| The Dark Side of Contracts, or Things you Mother Never Told you | |
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| Win-Win Relationships | |
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| Conclusion | |
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| Regulatory Issues | |
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| New Regulations | |
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| Form FDA 1572-What are you Really Signing? | |
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| IRBs | |
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| HIPAA | |
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| Drug Accountability | |
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| Financial Disclosure, or Whose Business is it Anyway? | |
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| Audits | |
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| How to Prepare for an Audit | |
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| Conclusion | |
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| Study Start-Up | |
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| Informed Consent: Safe, Sane, and Consensual | |
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| Start-Up in Theory | |
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| Start-Up in Practice: The Paper Trail-Implementing Regulatory Details | |
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| Initiation Visit | |
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| Electronic Medical Records | |
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| Volunteer Recruitment Strategies | |
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| Advertising | |
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| Web Advertising and Social Networking | |
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| Approaching the Patient, or "you Want me to do What?" | |
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| Conclusion | |
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| Study Activities: Strategies and Tools | |
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| SOPS-Why Bother? | |
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| Study Tracking: What Day is Today? | |
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| General Tracking Procedures | |
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| Worksheets, Forms, and Study Folders: Getting in Touch with your Inner OCD | |
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| Project Management Techniques | |
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| Software Programs | |
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| Coping with Minutiae | |
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| Billing Compliance-Practicalities | |
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| Drug Storage and Accountability | |
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| Maintaining Drug and Supply Inventories | |
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| Monitoring Visits | |
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| Volunteer Retention and Satisfaction | |
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| Patient Instructions | |
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| The Paper Trail Continues | |
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| Study Closing | |
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| Conclusion | |
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| Perspective on the State of the Industry | |
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| Costs of Clinical Trials | |
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| "Breaking the Scientific Bottleneck" | |
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| Where have all the Trials Gone? | |
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| Overseas Drug Manufacturing | |
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| Conclusion | |
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| Ethical Issues in Human Subjects Research | |
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| Historical Context | |
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| Ethical Principles (the Belmont Report) | |
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| Special Populations | |
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| Individual Research Practice: The Nature of the Beast | |
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| Financial Pressure and Conflict of Interest | |
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| Whose Body is it? Tissue Ownership | |
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| Patient-Prompted Ethical Issues | |
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| Adverse Events: Related Ethical Issues | |
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| Publication Ethics | |
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| Practice Guidelines | |
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| Off-Label Uses | |
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| IRB-Related Ethical Issues | |
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| Unanticipated Risk in Clinical Trials | |
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| Who's Minding the Store? A Case Study | |
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| Conclusion | |
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| Society and Politics | |
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| Politics of Research: The FDA | |
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| Politics of Research: Women | |
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| Politics of Research: Religion | |
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| Politics of Research: Race | |
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| Politics of Research: Race and Gender Overlap | |
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| Politics of Research: Shifting Studies to Developing Countries | |
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| Justice and Societal Needs | |
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| Conclusion | |
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| Opportunities and Training in Clinical Research | |
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| Enhancing your Practice | |
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| Brief Training Options | |
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| Formal Training Programs | |
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| Conclusion | |
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| Epilogue | |
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| Background Resource Information | |
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| Suggested Resources | |
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| Career Information and Training Programs | |
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| Notes | |
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| Glossary and Acronym Guide | |
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| Bibliography | |
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| Index | |
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| About the Author | |