Polman, CH and Reingold, SC and Barkhof, F and Calabresi, PA and Clanet, M and Cohen, JA and Cutter, GR and Freedman, MS and Kappos, L and Lublin, FD and McFarland, HF and Metz, LM and Miller, AE and Montalban, X and O'Connor, PW and Panitch, H and Richert, JR and Petkau, J and Schwid, SR and Sormani, MP and Thompson, AJ and Weinshenker, BG and Wolinsky, JS (2008) Ethics of placebo-controlled clinical trials in multiple sclerosis - A reassessment. NEUROLOGY , 70 (13) 1134 - 1140.
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The increasing number of established effective therapies for relapsing multiple sclerosis ( MS) and emerging consensus for early treatment raise practical concerns and ethical dilemmas for placebo-controlled clinical trials in this disease. An international group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to reconsider prior recommendations regarding the ethics of placebo-controlled trials in MS. The group concluded that placebo-controlled trials can still be done ethically, with restrictions. For patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons ( e. g., economics). Suggestions are provided to protect subject autonomy and improve informed consent procedures. Recommendations are tighter than previously suggested for placebo-controlled trials in "resource-restricted" environments where established therapies may not be available. Guidance is also provided on the ethics of alternative trial designs and the balance between study subject burden and risk, scientific rationale and interpretability of trial outcomes.
|Title:||Ethics of placebo-controlled clinical trials in multiple sclerosis - A reassessment|
|Keywords:||INTERFERON BETA-1B TREATMENT, DOUBLE-BLIND, INFORMED-CONSENT, ISSUES, MS, MULTICENTER, NATALIZUMAB, HELSINKI, DECLARATION, DISABILITY|
|UCL classification:||UCL > School of Life and Medical Sciences > Faculty of Brain Sciences|
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