Rheumatoid arthritis antirheumatic drug trials. III. Setting the delta for clinical trials of antirheumatic drugs--results of a consensus development (Delphi) exercise.

Abstract

Defining the minimum clinically important difference or delta to be detected in a clinical trial depends on a number of factors including the research hypothesis, patient characteristics, the nature of the intervention and the trial design. In 2 previous studies, we have developed standardized procedures for conducting outcome measurement based on current Food and Drug Administration and European League Against Rheumatism guidelines for RA clinical trials, and thereafter, determined the standard deviation for these outcome measures. In the final component of this series of studies, we employed a Delphi technique to establish estimates for delta and calculated the sample size requirements under different conditions of Type I and Type II error probabilities.