Methodology of clinical trials in hand osteoarthritis: conventional and proposed tools.
BACKGROUND
Although very common, hand osteoarthritis (OA) is rarely the focus of clinical trials aimed at determining whether a drug is effective on its symptoms and/or anatomical progression. Besides the common difficulties met in trials in OA in general, the highly unpredictable course of hand OA presents specific challenges. However, hand OA is beginning to be considered as a potential model for the study of drugs in OA, since researchers now have at their disposal new clinical tools and radiological methods to assess with better accuracy and sensitivity either its symptomatic activity or its anatomical course.


METHODS
The now well-known consensual recommendations for the design and conduct of clinical trials in OA are reviewed, and the specific clinical tools and radiological methods available for the assessment of hand OA detailed. Some specific recommendations for the design of clinical trials in hand OA and the selection of patients for such trials are proposed, taking into account the particularities of this location of OA.
Lequesne
M G
MG
H pital Léopold Bellan, Paris, France. mlequesne@aol.com
Maheu
E
E
D006227:Hand Deformities, Acquired / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D010003:Osteoarthritis / Q000175:diagnosis / Q000188:drug therapy*; D018579:Patient Selection; D012107:Research Design; D012680:Sensitivity and Specificity; D016896:Treatment Outcome