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

IRB Bios

John M. Isidor, JD

John M. Isidor, JD, is CEO of Schulman Associates Institutional Review Board, Inc., an independent IRB located in Cincinnati, Ohio. Previously, Mr. Isidor served as a litigation attorney in Cincinnati, specializing in civil and criminal law. Since becoming involved in clinical research through his affiliation with Schulman Associates IRB, Mr. Isidor has become a frequent lecturer on how legal and regulatory issues affect the conduct of clinical trials. Mr. Isidor has authored several articles regarding legal and ethical issues relating to clinical research. He has co-authored four chapters for a textbook entitled Institutional Review Board; Management and Function that was published in 2005, and is a member of the editorial advisory boards of the Guide to Good Clinical Practice and IRB Advisor, and BNA’s Medical Research Law and Policy. Mr. Isidor is licensed to practice law in Ohio as well as before the United States District Court in Ohio, the United States 6th Circuit Court of Appeals and the United States Supreme Court. He is a member of the Cincinnati, Ohio and American Bar Associations, and received his law degree from Northern Kentucky University.

Alexa Boer Kimball, MD, MPH

Alexa Boer Kimball, MD, MPH, is Director of CURTIS, the joint Clinical Unit for Research Trials in Skin at Massachusetts General Hospital and Brigham and Women’s Hospital at Harvard Medical School in Boston, Massachusetts. Dr Kimball conducts an active unit including phase 1 through phase 4 studies in diverse areas using topical and systemic agents for skin disease. She has also done extensive research in the areas of physician workforce and quality of life. Dr. Kimball received her medical degree from the Yale University School of Medicine in New Haven, Connecticut. Her postgraduate work included an internship at Beth Israel Hospital/Harvard University in Boston, Massachusetts, and residency in dermatology at the Stanford University School of Medicine in Stanford, California, where she also served as Chief Resident. Following her residency, Dr. Kimball went on to complete a clinical research fellowship in dermatology at the National Institutes of Health in Bethesda, Maryland, and she concurrently obtained an MPH with a focus on clinical trials from the Johns Hopkins School of Public Health. Dr. Kimball is currently an Assistant Professor at Harvard Medical School and holds a number of major national appointments, including positions on the Society for Investigative Dermatology’s Committee on Government and Public Relations and Deputy Chair of the Membership Committee for the American Academy of Dermatology. Dr. Kimball is Associate Editor for the “Clinical Trials and Therapeutics” section of the Journal of the American Academy of Dermatology. Her publications, which cover topics ranging from employment trends in the dermatologic specialty to the epidemiology and treatment of psoriasis, have appeared in journals such as the Archives of Dermatology, Journal of the American Academy of Dermatology, Arthritis and Rheumatism, and the British Journal of Dermatology. She is also the author of 100 Q & A about Psoriasis.