Methodology issues in the evaluation of NSAID in inflammatory rheumatic diseases.

The characteristics required of tests used in trials of nonsteroidal antiinflammatory drugs in patients with inflammatory rheumatic diseases in order for such tests to provide meaningful results are reviewed. Those tests most widely used in trials of patients with rheumatoid arthritis or ankylosing spondylitis are assessed, and the ability of such tests to discriminate among the treatment effects of different agents is considered. Finally, several statistical and procedural issues important to clinical trial methodology are discussed.