May 27, 2011 Current study designs, assessing the effectiveness of new drugs for the treatment of rheumatoid arthritis (RA), discriminate against patients in the placebo-group, according to a critical appraisal assessing 17 trials, presented at the EULAR 2011 Annual Congress. The authors of the study hypothesize that an active comparator group (i.e. current standard of care) should be used in all future new drug study designs as using placebo groups is not ethically acceptable.
The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking the new treatments. The study analysed current study designs, for new therapies such as abatacept (Orencia®), golimumab (Simponi®) or tocilizumab (Actemra®), and showed that patients in the placebo group experienced no change in medication, having to continue with their former, ineffective treatment plus placebo.
"According to the Helsinki-Declaration of the World Medical Association*, a placebo-controlled study design is deemed to be ethically acceptable when there is no other effective treatment," said Dr. Juche, Johanniter-Hospital, Treuenbrietzen, Germany. "However, this analysis confirms that patients in the placebo-group are at a disadvantage as they are given no change in medication to reduce their active inflammatory condition or halt disease progression. Our recommendation is that future clinical trials should include an active comparator group to ensure that all patients receive effective treatments to improve their quality of life."
In the analysis, researchers used studies from the European Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for abatacept, golimumab and tocilizumab as samples. The studies chosen had to be placebo controlled at the beginning and state clinical relevant outcome criteria (e.g. DAS28**, ACR20***, Health Assessment Questionnaire and joint erosion scores).
*The World Medical Association (WMA) is an organisation promoting the highest possible standards of medical ethics. The WMA provides ethical guidance to physicians through its Declarations, Resolutions and Statements.
**DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual's RA is.
***ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts.
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