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MENTAL HEALTH EFFECTIVENESS TRIALS SHOULD INCLUDE NO-TREATMENT ARM, CDER's TEMPLE SUGGESTS; DATABASE STUDIES TO SHOW DRUG EFFECT ARE PROBLEMATIC, HE SAYS

Executive Summary

Effectiveness trials in therapeutic categories such as depression or anxiety should include a placebo or minimal-treatment arm, Center for Drug Evaluation & Research Associate Director for Medical Policy Robert Temple, MD, told a Drug Information Association meeting in Bethesda, Md. Oct. 24.
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