Arlington, Va., January 16, 2008 -- The American Psychiatric Association (APA) and the American Academy of Child and Adolescent Psychiatry (AACAP) today 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.
Alissa Schulman, (APA) 703-907-8640
Aschulman@psych.org
Kristin Kroeger Ptakowski (AACAP) 202-966-7300, ext 108
kkroeger@aacap.org
“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,” 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 largest 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."
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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 www.psych.org and www.HealthyMinds.org.
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. Visit AACAP at www.aacap.org.
Alissa Schulman, (APA) 703-907-8640
Aschulman@psych.org
Kristin Kroeger Ptakowski (AACAP) 202-966-7300, ext 108
kkroeger@aacap.org
Leading Psychiatric Medical Associations Speak Out On New Antidepressant Clinical Trials Study
Arlington, Va., January 16, 2008 -- The American Psychiatric Association (APA) and the American Academy of Child and Adolescent Psychiatry (AACAP) today 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 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,” 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 largest 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 www.psych.org and www.HealthyMinds.org.
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. Visit AACAP at www.aacap.org.
