Quality management of Advanced medical care clinical resarch under Clinical Trial Act for pharmaceutial approval application

2023 Fiscal Year Final Research Report

• Project/Area Number: 20K12715
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 90140:Medical technology assessment-related
• Research Institution: Okayama University
• Principal Investigator: Sakurai Jun 岡山大学, 大学病院, 教授 (30444657)
• Co-Investigator(Kenkyū-buntansha): 四方 賢一 岡山大学, 大学病院, 教授 (00243452) ; 堀田 勝幸 岡山大学, 大学病院, 教授 (70379816) ; 大野 彩 (木村彩) 岡山大学, 大学病院, 講師 (20584626) ; 加藤 有加 岡山大学, 大学病院, 助教 (50544904)
• Project Period (FY): 2020-04-01 – 2024-03-31
• Keywords: 臨床研究法 / 特定臨床研究 / 先進医療 / 品質マネジメント / 薬事承認申請

Outline of Final Research Achievements

The purpose of this study is to clarify the quality level for the efficient application of regulatory approval for advanced medical care B, taking into account discussions with regulatory authorities such as the PMDA and the Ministry of Health, Labour and Welfare. From fiscal year 2020 to 2023, we developed procedural documents and forms for quality risk management, improved the quality of monitoring and data management, and examined methods for utilizing specified clinical trial data for regulatory applications. This research clarified the quality level of advanced medical care B, leading to more efficient and cost-effective trials. In addition, staff training and guideline development were conducted, improving the overall awareness of quality management within the organization. Furthermore, we continued to support advanced medical care 2 trials and verified the executability of quality risk management.

Free Research Field

医薬品評価学

Academic Significance and Societal Importance of the Research Achievements

「先進医療Bを含む特定臨床研究」の位置づけを明確化し、規制当局との議論の上で試験実施前から品質レベルを一定に保つことで、臨床研究の実施にかかる無駄な品質維持コスト（オーバークオリティ）を避け、かつ研究支援業務の効率化を図ること、並びに試験結果を今後の臨床研究やシーズの研究開発に活かし、「開発の手戻りを回避」して開発コスト低下を図ることが可能となる。