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.