Primer: Establishing a clinical trial unit – regulations and infrastructure

Journal: Nature Clinical Practice. Rheumatology. 2007 Apr;3(4):234-9.

Author and affiliations: R Fleischmann. the University of Texas Southwestern Medical Center at Dallas and Metroplex Clinical Research Center, Dallas, Texas, USA. [E-mail: ]

PMID: 17396109

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.

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