Background: 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.
Methods: Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, a large nationally representative sample of 34,653 adults from the US population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy clinical trials to all adults with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of SAD (n = 965) in the past 12 months and then to a subsample of participants seeking treatment (n = 363). Our aim was to assess how many participants with SAD would fulfill typical eligibility criteria.
Results: We found that more than 7 of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than 6 of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least 1 criterion. In addition, more than 8 of 10 respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial. Having a current major depression explained a large proportion of ineligibility.
Conclusions: Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use. For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.