Tying comparative effectiveness information to decision-making and the future of comparative effectiveness research designs: the case for antipsychotic drugs.

The outcome of comparative effectiveness research on antipsychotic drugs, specifically the National Institute of Mental Health-funded CATIE trial, has raised questions regarding the value of second-generation antipsychotic drugs and has sparked a debate regarding their accessibility through public insurance. We reviewed the evidence on the impact of access restrictions for antipsychotic drugs in Medicaid programs and found that such restrictions resulted in increases in overall costs and a possible decline in the quality of care. We attribute this unwanted outcome to limitations in comparative effectiveness research designs that fail to inform either clinical or policy decision-making. We enumerate these limitations and illustrate the potential for more innovative comparative effectiveness research designs that may be in line with clinical decision-making using an original analysis of the CATIE trial data. The value of genomic information in enabling better trial design is also discussed.