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

Introduction

Clinical research is an important and exciting social activity that plays a pivotal role in medicine and healthcare. Clinical research is essential in advancing our knowledge; it brings new therapies to market and expands the use of existing therapies with new indications. A large proportion of our knowledge of a drug’s risk and benefits to society is developed inside these research programs. In many cases, well-conducted clinical research advances a standard of care across a variety of diverse states. All of these activities occur in a highly formalized, highly regulated, and carefully monitored environment that touches on all aspects of our social and political systems.

For us, participating in clinical research is a great adventure. We have participated in cutting-edge research through which we have interacted with other key investigators, scientists, patients, and business people from around the world. In addition to advancing knowledge in our fields, we have had the opportunity to gain recognition for being involved in key studies and publications.

While participating in clinical research studies can be rewarding on many levels, the resources, staffing, and time constraints can be substantial, and thus, only appeal to a small proportion of practitioners. The best-run research can be profitable, but many only cover costs. The extra time, diligence, and responsibilities applied to clinical research is often taxing. Most vexing is a poor understanding of the pressures involved in clinical research.

The International Psoriasis Council (IPC) identified a need for educating clinicians interested in clinical research, as well as nurses and administrators, on the various aspects of conducting clinical trials, hopefully, to increase the number of clinical researchers. This handbook is derived from a clinical conference sponsored by IPC to discuss important elements of conducting clinical research in both private practice and academic settings. It is designed to help the reader gain insight into aspects of conducting good clinical research, identifying common pitfalls, and providing practical and technical details of the clinical research process. This is a resource for those interested in becoming involved in their first clinical trial or those who are already involved and looking for greater participation. We believe that teaching clinicians to become better investigators will bring value to the medical community, the pharmaceutical industry, and most importantly, to patients.

As co-chairs of this program, we truly hope you find this to be a valuable resource, whether you are considering participation as an investigator for the first time or have already been involved in several research studies.

DrLeonardi
DrPapp

^{Craig L. Leonardi, MD} ^/ ^{Kim Alexander Papp, MD}