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

Recruitment Bios

Robert T. Matheson, MD

Robert T. Matheson, M.D. is Clinical Professor of Dermatology at the Oregon Health Sciences University, and serves as Principal Investigator and Director of Oregon Medical Research Center in Portland, Oregon. Following an undergraduate degree in mathematics from the University of Utah, he attended the Medical College of the University of Utah and there completed an internship in internal medicine. While there, he performed clinical studies on Vitamin D metabolism in the Department of Gastroenterology. He then served as a general medical officer in the Indian Health Service in Phoenix, Arizona. Following which, he moved to Portland, Oregon, where he completed a research fellowship studying inflammatory mediators under Dr. Kirk Wuepper in the Department of Dermatology of the Oregon Health Sciences University. For this project he was awarded the Stellwagon Award by the Academy of Dermatology. After completing a residency and board certification in dermatology, he entered the private practice of dermatology, which included medical, surgical, and cosmetic dermatology, as well as conducting clinical trials. The last 7 years have been devoted exclusively to full time clinical research, performing over 300 studies from Phase 1 through IV for over 100 sponsors and CRO’s. Dr. Matheson’s professional activities include membership in multiple local, national, and international organizations. He has authored numerous publications and served on mutiple advisory boards.

Kim Alexander Papp, MD, PhD, FRCPC

Canadian Dermatologist, Kim Alexander Papp, M.D., Ph.D., F.R.C.P.C. is the founder and President of Probity Medical Research, an organization that guides research physicians in the conduct of clinical research studies. Over the past 15 years Dr. Papp has conducted more than 170 clinical trials and followed over 2700 subjects in these studies. Dr. Papp has authored or co-authored more than 190 publications and abstracts on the results of his work. Dr. Papp has been an investigator in research studies on over 45 unique compounds in development for the treatment of Psoriasis. In addition to his passionate dedication to clinical research, Dr. Papp maintains a large, private medical dermatology practice where he follows thousands of psoriasis patients. Prior to his current positions, Dr. Papp taught at York University as well as the University of Waterloo. In his spare time, Dr. Papp trains and conducts seminars for other dermatologists around the world on new and developing therapies for dermatology. Dr. Papp is a Fellow of the Royal College of Physicians and Surgeons of Canada and a specialist in Dermatology. He received his Doctor of Medicine degree from the University of Calgary Medical School and survived his residency in Internal Medicine and Dermatology at the University of Toronto. Dr. Papp holds positions in both public and professional organizations including, Councilor for the International Psoriasis Council and Committee Representative for Dermatology at the Ontario Medical Association. He is also a member of several international organizations including the Canadian Dermatology Association, the European Academy of Dermatology and Venereology, the American Academy of Dermatology and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He serves on numerous advisory boards and is a consultant for several pharmaceutical and biotech corporations.