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trials exclude most 'real world' patients with
More than 80 percent of people with depression in
the general population aren't eligible for clinical trials
of antidepressant drugs.
At least five patients would need to be screened to enroll
just one patient meeting the typical inclusion and
exclusion criteria for antidepressant registration trials
(ARTs), suggests the new research by Drs. Sheldon Preskorn
and Matthew Macaluso of University of Kansas School of
Medicine-Wichita and Dr. Madhukar Trivedi of Southwestern
Medical School, Dallas. The study highlights some major
differences between patients with depression seen in
everyday clinical practice and those enrolled in ARTs--the
studies of antidepressants that lead to FDA drug approval.
The researchers hope their work will help drug developers
understand how inclusion and exclusion criteria may affect
enrollment in ARTs, and help them in developing an
appropriate recruitment plan and timeline. "The timelines
in most drug studies are unrealistically short and their
recruitment plans are often woefully inadequate, resulting
in studies that take longer than expected to complete and
frequent budget overruns," Drs. Preskorn, Macaluso, and
Trivdei write. Failure to consider the effort needed for
ART recruitment might lead to lost revenue, delays in
bringing a drug to market, or failure to develop a
potentially effective medication.
The findings may also help to explain to healthcare
practitioners why ARTs tend to overestimate the benefits
of antidepressant treatment in "real world" patients with
depression. "Obviously," the researchers add, "the more
patients who are excluded from the ARTs, the greater the
chances that the results will not generalize to the
routine clinical practice."
Journal of Psychiatric
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