Current Status and Perspectives of Placebo-controlled Studies

The Subcommittee on Placebo-controlled Studies of the Pharmaceuticals and Medical Devices Agency (PMDA) Science Board (hereinafter referred to as the “Subcommittee”) discussed and summarized basic perspectives on the need for placebo-controlled studies for the assessment of the efficacy of pharmaceuticals. Given that various factors may hinder the conduct of placebo-controlled studies, clarifying these factors and assessing their validity will provide important information for determining the application of placebo-controlled studies for future individual clinical trials.