Guidelines for antiinflammatory drug research.

Guidelines have been developed by the Bureau of Drugs, FDA, for antinflammatory drug development. They address the problem of efficacy and safety testing but leave the definition of qualified investigators and appropriate subjects unstated. The natural history of rheumatoid arthritis, the most-studied chronic inflammatory disorder, is not sufficiently appreciated, and "controlled" studies are too narrowly structured to give adequate information. By contrast, other countries speed the review process by emphasizing early toxicity studies and letting the market place determine relative efficacy while long-range safety data are carefully monitored.