Primer: establishing a clinical trial unit - regulations and infrastructure.
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.
Fleischmann
Roy
R
University of Texas Southwestern Medical Center at Dallas, and Metroplex Clinical Research Center, Dallas, TX 75235, USA. rfleischmann@arthdocs.com
D018501:Antirheumatic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000379:methods*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D012108:Research Personnel; D012216:Rheumatic Diseases / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D018501:Antirheumatic Agents