Towards more informative pilot studies with new anti-rheumatic drugs.
No subject should be exposed to a new drug without fully studying the experience. Methodologic standards implemented in Phase I trials can improve their usefulness. Standardization of outcome measures of impairment and function to permit pooling of data; utilization of techniques to minimise measurement error; collecting information on co-variates known to affect outcome-socioeconomic status, co-morbidity, etc; definition of a meaningful clinical change in absolute and relative forms by consensus techniques. Phase I trials should also incorporate features from single subject crossover designs and sequential trials.
Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Mass.
M H
MH
Liang
R B
RB
Brigham
D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic; D012015:Reference Standards; D012107:Research Design
D000893:Anti-Inflammatory Agents