title: The use of clinical trials in comparative effectiveness research on mental health.
abstract: OBJECTIVE
  A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health.
  
  
  METHODS
  Examination of three ongoing randomized clinical trials in psychiatry addressing issues that would pose difficulties for nonexperimental CER methods.
  
  
  RESULTS
  Existing statistical approaches to nonexperimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout.
  
  
  CONCLUSIONS
  Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult-to-reach populations, or when examining sequential treatments or stepped-care algorithms. Progress in CER on mental health will require careful consideration of appropriate selection between clinical trials and nonexperimental designs and on allocation of research resources to optimally inform key treatment decisions for each patient.
authors.affiliation: Department of Psychiatry, New York State Psychiatric Institute, Columbia University, New York, NY 10032, USA. Cblanco@nyspi.columbia.edu
authors.forename: Carlos
authors.initials: C
authors.lastname: Blanco
authors.forename: Claudia
authors.initials: C
authors.lastname: Rafful
authors.forename: Mark
authors.initials: M
authors.lastname: Olfson
mesh_terms: D000328:Adult; D015982:Bias; D001943:Breast Neoplasms / Q000150:complications / Q000453:epidemiology; D015897:Comorbidity; D057186:Comparative Effectiveness Research / Q000191:economics / Q000379:methods*; D003627:Data Interpretation, Statistical; D003865:Major Depressive Disorder / Q000453:epidemiology / Q000628:therapy; D019317:Evidence-Based Medicine; D005260:Female; D005715:Gambling / Q000628:therapy; D006297:Health Services Accessibility; D006630:Hispanic or Latino / Q000523:psychology / Q000706:statistics & numerical data; D006801:Humans; D010349:Patient Compliance / Q000523:psychology / Q000706:statistics & numerical data; D010352:Patient Dropouts / Q000523:psychology / Q000706:statistics & numerical data; D011570:Psychiatry; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards; D012109:Research Support as Topic
keywords: Access to treatment; Clinical trials; Comparative effectiveness research; Major depression; Mental health; Pathological gambling