Outcomes of patients in trials; Better blood pressure treatment; Snake bites...( >The authors found 25 RCTs that met the...),Health

>The authors found 25 RCTs that met these requirements, involving nearly 18,000 patients. Overall 45% of patients had received a randomly assigned treatment as part of a clinical trial, while 55% of patients did not in the end participate in the trial and received individualized treatment. Most of the RCTs studied new treatments for cancer, problems of the heart and circulation, and obstetric and gynecological problems.

The health outcomes recorded in the trials varied and included, for example, death or recurrence of cancer. In 22 of these trials, the health outcomes were no different (statistically) in patients who received randomly assigned treatment and those who received individualized treatment. In one trial the randomized patients fared better, and in the remaining two trials the patients receiving individualized treatment fared better.

These findings, say the authors, suggest that "randomized treatment allocation as part of an RCT is unlikely to be harmful."

This does not imply, they say, that all research is free of risk, as the risks and benefits of experimental treatment may vary substantially between studies. "However, in the situation in which patients will have access to the treatments that are used in the study setting regardless of whether the patient enrolls, prospective participants and their referring physicians should be reassured: there is no evidence that random treatment assignment leads to worse clinical outcomes."

Citation: Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D (2006) Does random treatment assignment cause harm to research participants? PLoS Med 3(6): e188.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pmed.0030188

PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-03-06
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Contact: Andrew Hyde
ahyde@plos.org
44-122-346-3330
Public Library of Science
5-Jun-2006

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