Society task force develops guidelines for placebos. (National MS Society News).When science looks at new treatments for MS, "placebo-controlled" trials are the most efficient and the easiest to interpret. But is it ethical to set up a clinical trial in which some people with MS will receive an inactive substance, a placebo, instead of one of the disease-modifying drugs known to slow the effects of MS? To address this issue, the Society convened an international task force to assess the problem and develop recommendations for the ethical use of placebos in future clinical trials for MS. Chaired by Dr. Fred D. Lublin of Mount Sinai School of Medicine
Mount Sinai School of Medicine is a medical school found in the borough of Manhattan in New York City. in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , clinicians, statisticians Statisticians or people who made notable contributions to the theories of statistics, or related aspects of probability, or machine learning: A to E
pl.n. 1. A chronological record of the events of successive years. 2. A descriptive account or record; a history: "the short and simple annals of the poor" of Neurology neurology (n  rŏl`əjē, ny–), study of the morphology, physiology, and pathology of the human nervous system. last spring, and an accompanying editorial by a medical ethicist eth·i·cist also e·thi·ciann. A specialist in ethics. Noun 1. ethicist - a philosopher who specializes in ethics ethician philosopher - a specialist in philosophy stressed their importance, especially in light of changing views on the ethics of placebo-controlled trials as detailed in the World Medical Association's Declaration of Helsinki For the political accords, see . . There is also another Declaration of Helsinki, dealing with the Information Society.[1] Introduction The Declaration of Helsinki,[2] was developed by the World Medical Association[3] . Briefly: * It is ethical to offer placebo-controlled trials to people with forms of MS for which there are available treatments only when these individuals formally decline to use them. The researchers conducting the study must inform the participants--fully and clearly--and should actively recommend use of the approved treatments. Each participant has to decline in writing. The researcher must continue informing the participant about other medications that become available during the course of the trial. * It is ethical to offer placebo-controlled trials to individuals for whom available therapy has failed. If other proven therapies are available, these alternatives should be recommended before offering participation in a trial. * It is ethical to offer placebo-controlled trials to people who have forms of MS for which there are no approved or available treatments. * Shortening a clinical trial or reducing its sample size to minimize time on placebo or numbers of people exposed to placebo does not justify a placebo-controlled trial if the participants have other treatment options and have not declined to use them. * It is not ethical to conduct placebo-controlled trials in resource-poor countries simply because approved treatments are not available there. There must be a commitment that the drug being tested, if shown to be safe and effective, will be made available to people with MS in such a country. The task force's recommendations are offered to guide future MS clinical trials. As new therapies are developed, the guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. may be reconsidered and modified. |
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