International Psoriasis Council

Chapters

Opening
Introduction
Chapter 1
The Evolution of the Clinical Trials Process - A Brief History Lesson
Chapter 2
It Takes a Village to Conduct a Clinical Trial
Chapter 3
Not All Clinical Trials are Created Equal - Understanding the Different Phases

Chapter 4
There's No Going Outside the Lines - Ethical Considerations in the Conduct of Clinical Trials
Chapter 5
What You Need to Know to Live in Harmony with Your Institutional Review Board and Research Ethics Committee
Chapter 6
Be Informed About Informed Consent
Chapter 7
Practical Advice for Following Good Clinical Practice
Chapter 8
Living in a Material World - What is Needed to Run a Successful Clinical Trial
Chapter 9
Clinical Trial Coordinators - A Vital Sign of a Good Clinical Trial
Chapter 10
The Subject of Recruitment and Retention
Chapter 11
The Investigational Compound - Like Handling Kryptonite
Chapter 12
Budgets and Contracts - Show Me the Money
Chapter 13
Everything You Write Can Be Used Against You in a Court of Law - Understanding Proper Documentation
Chapter 14
Audits/Inspections - Be Prepared for Anything
Chapter 15
Conducting Clinical Trials Without Ending Up on Trial

Phases Bios

Cynthia Guzzo, MD

Cynthia Guzzo is a Vice President in Immunology Clinical Research and Development at Centocor. She leads the dermatology and gastroenterology groups within Immunology and is responsible for the design, conduct, analysis and regulatory submission of dermatology and gastroenterology clinical studies. Dr. Guzzo played a leadership role in the development and approval of several biologic agents for the treatment of psoriasis and psoriatic arthritis. Prior to joining Centocor in 2002, she served as Director of Worldwide OTC Development at Merck Research Laboratories. Dr. Guzzo graduated from the University of Pittsburgh School of Medicine. After a pediatric internship and fellowship in physician investigator training, she completed her dermatology training at the University of Pennsylvania. Following her residency, she remained there to direct the Dermatology Clinical Study Unit and the Psoriasis and Phototherapy Center. Dr. Guzzo served on the Medical Advisory Board of the National Psoriasis Foundation and the Phototherapy and Psoriasis Task Force of the American Academy of Dermatology. She has contributed significantly to the dermatology literature and is the author of peer-reviewed manuscripts and book chapters. She is a board certified dermatologist.