May 27, 2011
The Use Of Placebo In Rheumatoid Arthritis Clinical Trials May Negatively Impact Patients
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 (OrenciaÃ®), golimumab (SimponiÃ®) or tocilizumab (ActemraÃ®), 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."
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