Clinical trials in rheumatology.

The randomized controlled trial continues to be the standard for evaluating the clinical utility of new procedures or treatments. The randomized controlled trial seems to affect the clinical practice of physicians. Although the design of the randomized controlled trial is well described, consideration should be given to the questions asked and whether the trial is conducted and analyzed so that the questions can be answered. Comparative trials have become more frequent than placebo trials in the past decade, and clinical research financing is falling increasingly to the pharmaceutical industry. Process and outcome measures are receiving more attention. Various groups and committees are evaluating disease activity measures to delineate a small number that can become core or foundation measures. These measures are also being defined and standardized. The process is much further advanced for rheumatoid arthritis than for other diseases, and some common and perhaps "mundane" disease states are being neglected.