Primer: establishing a clinical trial unit-regulations and infrastructure.

1: Nat Clin Pract Rheumatol. 2007 Apr;3(4):234-9.

Fleischmann R.
R Fleischmann is a Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas, and Co-Medical Director of Metroplex Clinical Research Center, Dallas, TX, USA.

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.

PMID: 17396109 [PubMed – in process]

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About FMS Global News

Folllowing Rick Usher's death in December 2008, at his request in September of that year, I had agreed, as his principal contributor and an experienced journalist, to run the FMS Global News service due to his heavy commitments to music and raising research funds through this avenue. Following his sad and sudden death I hope to continue his work as he would have wished.
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One Response to Primer: establishing a clinical trial unit-regulations and infrastructure.

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