The American Psychiatric Association (APA) and the American
Academy of Child and Adolescent Psychiatry (AACAP) renewed their call for a
mandatory public registry for clinical trials in light of a study that shows medical research
is published selectively, effectively suppressing and misrepresenting studies deemed
negative.
"Our patie nts 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," said APA President Carolyn Robinowitz, M.D. "Open access to all
clinical trial data is necessary to better understand the risks and benefits of treatments."
"Issues involving publication bias are not unique to psychiatry," Robinowitz said.
"Publication bias has been well documented with cardiovascular and anti-inflammatory
medications. A clinical trials registry set up and overseen by the federal government
would be good for all of medicine."
The study, "Selective Publication of Antidepressant Trials and Its Influence on Apparent
Efficacy," analyzed 74 FDA-registered studies of 12 antidepressant agents. Researchers
found virtually all the studies identified as negative by the FDA were either never
published or published in a way that implied a positive outcome. The study found
virtually all positive studies were published.
"Selective reporting of clinical trial results may have adverse consequences for
researchers, study participants, health care professionals, and patients," the study authors
concluded.
The APA and AACAP were among the first medical specialty groups to call for the
establishment of a government-run public registry for all clinical trials, regardless of
results. In July 2004, the organizations successfully brought the issue to the forefront of
the American Medical Association, the nation's la rgest physician group, which prompted
the AMA to join in the call for a national registry. The APA and AACAP also support
federal legislation to provide open access to clinical trials data so physicians and families
can make fully informed decisions about treatments.
"Greater transparency in the clinical trials process, particularly including open access to
important data, is of significant benefit to the research community, to practitioners in the
field, and to our patients," said AACAP President Robert L. Hendren, M.D. "A national
registry will allow patients to have access data on a complete range of treatment options,
including medication, to discuss with their physician."
About the American Psychiatric Association
The American Psychiatric Association is a national medical specialty society whose more than 38,000
physician members specialize in the diagnosis, treatment, prevention and research of mental illnesses
including substance use disorders. Visit the APA at psych and HealthyMinds.
About the American Academy of Child and Adolescent Psychiatry
Representing over 8,000 child and adolescent psychiatrists nationwide, the American Academy of Child
and Adolescent Psychiatry is the leading authority on children's mental health. AACAP members actively
research, diagnose, and treat psychiatric disorders affecting children, adolescents, and their families.
American Academy of Child and Adolescent Psychiatry