Tuesday, October 10, 2006

Clinical trial ethics reconsidered?

drj writes "Ethical design of randomized controlled clinical trials has required that there be substantial uncertainty about which treatment is most likely to benefit the patient, a principle known as 'equipoise'. Fries and Krishnan examined all 45 trials reported at a professional rheumatology meeting and found that all trials gave results favorable to the industry sponsor, demonstrating a significant deviation from equipoise because the results were predictable. (Nearly all patients would be concerned with even a 70:30 outcome distribution.) The authors suggest that extensive preliminary findings produced a beneficial 'design bias'. This is good, they believe, because true equipoise is inefficient, exposes more patients to risk, and conflicts with other major ethical principles. They propose a principle of "positive expected outcomes". Is this a refreshing acknowledgement of reality and useful guide or just a rewording of accepted clinical practice where treatment group size already varies based on expected outcomes?"
Full text Fries & Krishnan, Arthr. Res. & Ther. 6(3), 2004. James F Fries and Eswar Krishnan "Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development" Arthritis Research & Therapy Vol 6 No 3

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