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Clinical trial participants fare no better, no worse than other patients

People who participate in randomized controlled studies to test new therapies seem to fare no better or no worse than those who receive the same care outside of such studies, a new review of research has found.1

The finding was published against a backdrop of debate about drug trials for popular pain-relievers and about whether trial results can be safely applied to an entire population. "These results challenge the assertion that the results of RCTs (randomized controlled trials) are not applicable to usual clinical practice," report the authors, who say this review is the most comprehensive of its kind conducted to date.

A randomized clinical trial is considered the "gold standard" of medical research because it is the best way to make sure that the only difference between the groups that are compared is the treatment they receive. Patients are assigned to each group randomly in order to increase the probability that differences between the groups can be attributed only to the treatment under study.

Critics, however, say the rigorous standards for inclusion in trials and the nature of those who conduct and participate in them mean that when a new drug or treatment is applied to a general population, the results might be different.

A recent article in the prestigious journal The Lancet suggested that clinical trials cannot be expected to be relevant to all patients with the same conditions for a number of reasons, such as selecting trial participants who are in better overall health, excluding people who have conditions in addition to the one being studied and the reality that in a general population patients will not always act according to doctors' instructions.

In the new study, researchers led by Gunn Elisabeth Vist of the Norwegian Health Services Research Centre, systematically identified and reviewed 55 studies involving a total of more than 31,000 patients who were treated in randomized clinical trials an
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Contact: GE Vist
gev@nhscr.no
Center for the Advancement of Health
23-Jan-2005


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