The 2nd Subcommittee on Placebo-controlled Studies

Agenda

1. Current situation of placebo-controlled studies
2. Others

List of Handouts

• Document 1-1　Specialties/areas where placebo-controlled studies are difficult to conduct
• Document 1-2　Specialties/areas where placebo-controlled studies are difficult to conduct(Modified version of the material of #1-1 for publishing purposes)
• Document 2　Current situation and issues of placebo-controlled studies: antidepressants
• Document 3　Necessity of phase III placebo-controlled studies as defined in the clinical evaluation guidelines
• Document 4-1　Recent major phase III clinical study designs for antidiabetic drugs
• Document 4-2　Recent major phase III clinical study designs for therapeutic drugs for osteoporosis
• Document 5　Discussion on the placebo-controlled setting in PMDA's new drug review and consultation service