Pharmacological and pharmacotherapy clinical trials may not yield representative results as too many patients are excluded from the studies.
Nicholas Hoertel, MD, MPH, of the French Institute of Health and Medical Research in Paris, and colleagues, examined data from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, which includes more than 34,000 adults. Their goal was to assess how many participants with social anxiety disorder (SAD) would fulfill typical eligibility criteria.
More than seven of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than six of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least one criterion, the researchers reported in the Journal of Clinical Psychopharmacology. Most of the ineligibility was related to participants having depression.
Also, more than 80% of respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial.
“Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use,” the researchers concluded. “For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.”
The present study sought to quantify the generalizability of clinical trial results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of social anxiety disorder (SAD) to a large representative community sample.