Conducting Clinical Research

ISBN-10: 0974917818

ISBN-13: 9780974917818

Edition: 2010

Authors: Judy Stone

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This book is a step-by-step, how to manual for both experienced medical professionals and novices who are looking to enter the field of clinical trials.
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Book details

List price: $69.95
Copyright year: 2010
Publisher: Mountainside MD Press
Publication date: 9/1/2010
Binding: Paperback
Pages: 464
Size: 7.00" wide x 9.75" long x 1.75" tall
Weight: 3.102
Language: English

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