Survey of the Current status and Challenges of Centralized Review in Multicenter Research in Japan.

Abstract

Centralized review can streamline multicenter research by shortening timelines, harmonizing decisions, and reducing administrative burden. However, adoption in Japan remains limited because many committees operate independently and regulations are complex. We conducted a questionnaire survey of 27 institutions in the Shizuoka Clinical Trials Network. For centralized review, we assessed feasibility, prior requests, and implementation experience. Twenty-two institutions responded, covering a range of hospital sizes and ethics review volumes. Although only 6 (27.3%) had implemented centralized review, 13 (59.1%) had received requests or inquiries, indicating demand where implementation has not occurred. Commonly cited barriers were inability to prepare procedures, staff shortages, and concerns about review quality. The main needs for implementation were personnel supplementation, knowledge and experience sharing, and system development. Addressing these challenges through standardized processes and unified document formats, shared from high volume institutions and supported by government led infrastructure, may promote wider adoption and reduce administrative workload.