Primer: establishing a clinical trial unit—regulations and infrastructure

Abstract

The performance of clinical trials can be very rewarding for the practicing or academic clinical rheumatologist. There are at least 50 new compounds—small molecules and biologics—in development for rheumatic diseases such as rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, scleroderma, gout and fibromyalgia. Clinical trials are important to try to determine the appropriate use of these compounds, as well as to answer questions about their safety. To carry out clinical trials effectively, the physician–investigator must be aware of, and adhere to, the regulatory requirements. The purpose of this article is to review these requirements in depth, as well as to discuss the infrastructure required to establish a successful clinical trial unit.

Key Points

• Clinical rheumatologists have a vested interest in performing clinical trials in order to try to find more effective and/or safer medications than current treatments for their patients with chronic disease

• There are very comprehensive and strict worldwide regulations about the conduct of clinical trials and patient safety

• Failure to adhere to the regulatory requirements can result in civil or criminal penalties for gross misconduct, and for further violations repeat studies might be prevented

• A successful clinical trial unit must have the people, space and equipment for studies to be performed accurately and well