Time for changes in the design, analysis, and reporting of rheumatoid arthritis clinical trials

✍ Scribed by David T. Felson; Jennifer J. Anderson; Robert F. Meenan

• Publisher: John Wiley and Sons
• Year: 1990
• Tongue: English
• Weight: 910 KB
• Volume: 33
• Category: Article
• ISSN: 0004-3591
• DOI: 10.1002/art.1780330119

✦ Synopsis

The randomized, controlled clinical trial has become the standard approach to evaluating the efficacy of slow-acting drugs in the treatment of rheumatoid arthritis (RA). Such trials, which were used as far back as the 1940s to evaluate antimalarial agents and gold and as recently as 1988 to evaluate sulfasalazine and methotrexate, compare an active drug with a placebo and use a number of measures to assess various aspects of patient outcome. The results are analyzed using statistical significance tests to examine the impact of therapy on various outcomes, such as the number of tender joints and the erythrocyte sedimentation rate (ESR).

Although the clinical trial approach has served to identify a number of effective drugs, we believe that it is time to change the ways in which RA clinical trials are designed, analyzed, and reported. The multiplicity of outcome measures has actually increased the difficulty of assessing the efficacy of a drug, and the commonly used methods of analyzing outcome measures tend to emphasize statistically significant improvement over the more important concept of clinical improvement.

Also, the development of new drugs has led to

From the Arthritis Center,