\Judy Stone, MD, is an infectious disease specialist who is Board Certified in Internal Medicine. She had a busy solo, 100 percent ID practice in rural Cumberland, Maryland.

In addition to her active clinical practice, Dr. Stone has had considerable experience attracting and successfully conducting numerous Phase 2 and 3 clinical trials for a variety of infectious disease indications over more than 20 years. She also is a speaker on antibiotics and infectious disease.

Dr. Stone volunteered to teach about HIV, STDs and infections in Dharamsala, India, in 2004. Subsequently, she attended the Gorgas Expert Course in Tropical Medicine in Lima, Peru, in 2005 and the Asian Tropical Infectious Disease Course in Bangkok, Thailand in 2006.

She has served on IDSA's Clinical Affairs Committee from 2005 - 2005, particularly enjoying the teaching and mentoring opportunities it has afforded her.

She is the author of the forthcoming books Volunteering in Clinical Research: A Consumer's Guide and Conducting Clinical Research:Forms and Templates. Dr. Stone is now a section lead author and editor on Medpedia.

Preface	p. ix
How Not to Kill the Patient-or the Investigator	p. ix
Why Read This Book? A View from the Trenches	p. ix
Acknowledgments	p. xiii
Introduction	p. xv
Overview	p. 3
Why do Studies?	p. 3
Liability?	p. 4
Jargon	p. 5
Who's Who	p. 5
Study Activities	p. 10
Phases of Drug Development	p. 10
Protocol Design Part 1: Parts of a Protocol	p. 16
Protocol Design Part 2: Patient Mix	p. 18
Product Quality: Seals of Approval	p. 19
Protocol Design Part 3: Mixing the Ingredients	p. 20
Medical Device Trials	p. 22
Vaccines and Other Biologics	p. 28
The Evolution of U.S. Drug Law	p. 38
Problems with Antibiotics	p. 41
Conclusion	p. 43
Scrounging Your First Study	p. 45
What do You Need to Get Started?	p. 45
Navigating Site Selection: Landing your First Study	p. 48
Newer Methods for Landing a Study	p. 49
Why It's so Difficult to Get Studies	p. 53
Site Selection: Be Careful What you Wish for-you Might Get it	p. 55
Site Selection: Why a Site is Chosen, or a Marriage of Convenience	p. 57
Site Qualification Visit, or "Shall we Dance?"	p. 59
Do Size and Setting Matter?	p. 62
Conclusion	p. 65
Reality Testing: Feasibility, Budgets, and Contracts	p. 67
Feasibility Overview	p. 67
Protocol Feasibility	p. 68
Patient Pool	p. 72
Staffing	p. 73
Regulatory Considerations: IRBs	p. 76
Managing the IRB Submission Process	p. 78
Regulatory Considerations: Billing for Clinical Trials	p. 80
Antikickback, False Claims, and Stark Laws	p. 82
Budget Feasibility	p. 83
CROs and SMOs-Dealing with the Middleman	p. 97
Contract Basics	p. 100
The Dark Side of Contracts, or Things you Mother Never Told you	p. 109
Win-Win Relationships	p. 110
Conclusion	p. 112
Regulatory Issues	p. 113
New Regulations	p. 115
Form FDA 1572-What are you Really Signing?	p. 121
IRBs	p. 123
HIPAA	p. 125
Drug Accountability	p. 129
Financial Disclosure, or Whose Business is it Anyway?	p. 130
Audits	p. 132
How to Prepare for an Audit	p. 143
Conclusion	p. 145
Study Start-Up	p. 147
Informed Consent: Safe, Sane, and Consensual	p. 147
Start-Up in Theory	p. 157
Start-Up in Practice: The Paper Trail-Implementing Regulatory Details	p. 159
Initiation Visit	p. 160
Electronic Medical Records	p. 161
Volunteer Recruitment Strategies	p. 164
Advertising	p. 170
Web Advertising and Social Networking	p. 175
Approaching the Patient, or "you Want me to do What?"	p. 178
Conclusion	p. 180
Study Activities: Strategies and Tools	p. 181
SOPS-Why Bother?	p. 181
Study Tracking: What Day is Today?	p. 185
General Tracking Procedures	p. 185
Worksheets, Forms, and Study Folders: Getting in Touch with your Inner OCD	p. 186
Project Management Techniques	p. 189
Software Programs	p. 189
Coping with Minutiae	p. 190
Billing Compliance-Practicalities	p. 191
Drug Storage and Accountability	p. 192
Maintaining Drug and Supply Inventories	p. 193
Monitoring Visits	p. 194
Volunteer Retention and Satisfaction	p. 195
Patient Instructions	p. 198
The Paper Trail Continues	p. 202
Study Closing	p. 213
Conclusion	p. 216
Perspective on the State of the Industry	p. 217
Costs of Clinical Trials	p. 217
"Breaking the Scientific Bottleneck"	p. 225
Where have all the Trials Gone?	p. 237
Overseas Drug Manufacturing	p. 241
Conclusion	p. 242
Ethical Issues in Human Subjects Research	p. 243
Historical Context	p. 244
Ethical Principles (the Belmont Report)	p. 248
Special Populations	p. 255
Individual Research Practice: The Nature of the Beast	p. 258
Financial Pressure and Conflict of Interest	p. 258
Whose Body is it? Tissue Ownership	p. 265
Patient-Prompted Ethical Issues	p. 270
Adverse Events: Related Ethical Issues	p. 271
Publication Ethics	p. 275
Practice Guidelines	p. 277
Off-Label Uses	p. 278
IRB-Related Ethical Issues	p. 279
Unanticipated Risk in Clinical Trials	p. 281
Who's Minding the Store? A Case Study	p. 286
Conclusion	p. 290
Society and Politics	p. 293
Politics of Research: The FDA	p. 293
Politics of Research: Women	p. 300
Politics of Research: Religion	p. 307
Politics of Research: Race	p. 311
Politics of Research: Race and Gender Overlap	p. 313
Politics of Research: Shifting Studies to Developing Countries	p. 315
Justice and Societal Needs	p. 324
Conclusion	p. 336
Opportunities and Training in Clinical Research	p. 337
Enhancing your Practice	p. 338
Brief Training Options	p. 339
Formal Training Programs	p. 341
Conclusion	p. 344
Epilogue	p. 345
Background Resource Information	p. 349
Suggested Resources	p. 387
Career Information and Training Programs	p. 401
Notes	p. 443
Glossary and Acronym Guide	p. 511
Bibliography	p. 525
Index	p. 579
About the Author	p. 601
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