Diverse Roles and Characteristics of Academic Research Organizations in Japan: Results of A Questionnaire-Based Study.

Background: Clinical trials in Japan are governed by three regulations: Japanese Good Clinical Practice (J-GCP), the Clinical Trials Act, and the Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Academic research organizations (AROs) are non-profit entities established to support clinician-scientists in conducting rigorous and high-quality clinical trials. However, Japan's unique decentralized clinical trial system has resulted in relatively small AROs with diverse roles. Additionally, work style reforms among Japanese physicians pose challenges for allocating time to research. This study aimed to assess the demographics, activities, and roles of AROs in Japan.

Methods: We distributed a questionnaire survey to 31 AROs in Japan between October and December 2023. The survey collected data on organizational mission, vision, annual planning, clinical trial support, the number of supported studies, financial independence, and management of researchers' working hours.

Results: Responses were received from 20 AROs (64.5%), including five public university hospitals and two clinical research core hospitals. The median staff size was 26.7 (range: 2-80), with public university hospitals reporting a median of 22.6 (range: 1449). Y-NEXT had a larger staff size (53.4) compared with other public university hospitals but fewer than clinical research core hospitals (median: 78.5). Thirteen AROs (65.0%) reported having organizational missions, and 25.0% were financially independent. Effort allocation for staff varied among institutions, and six AROs (30.0%) managed researchers' working hours.

Conclusion: The roles and ultimate goals of AROs vary across institutions, highlighting the need for alignment with each institution's clinical research priorities and principles.