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Antidepressant Study Revives Efforts to Establish Public Clinical Trial Registry

(PSYCHIATRIC TIMES) - The American Psychiatric Association (APA) and the American Academy of Child and Adolescent Psychiatry (AACAP) renewed their 2004 call for a mandatory public clinical trial registry to be established and overseen by the federal government. This is in response to a study that showed that research on antidepressants is published selectively—effectively suppressing trials deemed negative and overstating the benefits of antidepressant therapy. The study was published in the January 17 issue of the New England Journal of Medicine.

A research team led by Erick H. Turner, MD, Oregon Health and Science University and Portland Veterans Affairs Medical Center, analyzed all phase 2 and phase 3 clinical trials of 12 antidepressant agents approved by the FDA from 1987 through 2004. “According to the published literature, the results of nearly all of the trials of antidepressants were positive. In contrast, FDA analysis of the trial data showed that roughly half of the trials had positive results,” the researchers wrote.

The team found that 23 of the 74 studies (31%) were never published. Sample size was not a factor in publication. However, what was a factor, the investigators reported, was outcome. Positive studies were 11.7 times more likely to be published than studies with negative or questionable findings (P = .001). Of the 38 studies (51%) viewed by the FDA as having positive results, 37 were published. The remaining 36 studies (49%) deemed by the FDA as having negative results (24 studies) or questionable results (12 studies), with 3 exceptions, either were not published (22 studies) or were published in a way that conveyed a positive outcome (11 studies).

The publication bias resulted in 94% (95% confidence interval [CI], 84% to 99%) of published studies appearing to have positive results, whereas the FDA analysis showed that only 51% (95% CI, 39% to 63%) of trials conducted had positive results, the researchers found. The bias also had an impact on effect sizes, which ranged from 11% to 69% for individual antidepressants (P = .001) and was 32% overall (P = .012).

“By altering the apparent risk-benefit ratio of drugs, selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health,” the researchers noted.

“Our patients deserve the best health care available, and having full disclosure of research findings—both positive and negative—will help clinicians develop the most effective treatment plans. Open access to all clinical trial data is necessary to better understand the risks and benefits of treatments,” said Carolyn Robinowitz, MD, APA president. “A national registry will allow patients to have access to data on a complete range of treatment options, including medication, to discuss with their physician,” added Robert L. Hendren, MD, AACAP president.

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