Short-term clinical trials of anti-rheumatoid drugs — an opinion
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Discussions pertaining to outcome and end-points in clinical trials in rheumatology have, in recent years, tended to disregard the so-called process measures in favour of measures of total health status, usually by questionnaires such as the Health Assessment Questionnaire (HAQ). This is perfectly reasonable in relation to the long-term benefits, or problems that might be expected of long-term therapy, but may not be sufficiently sensitive to detect the short-term differences between NSAID and ARD therapy. Until further properties of ARDs can be identified, or until a drug appears which is superior to present ARDs in terms of efficacy, then refined, cost-effective, short-term (about 20 weeks) trials using a small number of clinical and laboratory assessments in a small number of patients (15–30) represent an almost obligatory initial stage in the clinical development of new ARD therapy.
KeywordsClinical Trial Health Status Clinical Development Process Measure Health Assessment
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