Construction of support system for local community-based investigator-initiated clinical study

2014 Fiscal Year Final Research Report

• Project/Area Number: 24659230
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Medical sociology
• Research Institution: University of Tsukuba
• Principal Investigator: HASHIMOTO Koichi 筑波大学, 医学医療系, 教授 (80463826)
• Co-Investigator(Kenkyū-buntansha): NAKATA Yoshio 筑波大学, 医学医療系, 准教授 (00375461) ; HARADA Yoshinori 筑波大学, 学内共同利用施設等, 特命教授 (00455932) ; MAMIZUKA Naotaka 筑波大学, 医学医療系, 講師 (50580510) ; YASUDA Susumu 独立行政法人国立病院機構水戸医療センター(臨床研究部), その他(移行) (70528439) ; FUJIE Keiko 筑波大学, 医学医療系, 助教 (80623959)
• Project Period (FY): 2012-04-01 – 2015-03-31
• Keywords: 臨床試験 / CRC / リサーチアシスタント / プロジェクトマネジメント

Outline of Final Research Achievements

Objective of this study is a construction of support system for investigator-initiated clinical studies according to clinical needs of patients and medical staffs. As a model case, research assistants of our laboratory resided at a hospital of Mito area and carried out research supports such as CRC task and data management. Furthermore, three professional faculty members of clinical study visited the hospital monthly, and conducted individual consultations for doctors and other medical staffs such as nurses. Number of individual consultation was 119 studies for two years. In future, it might be needed to provide a support system of intervention studies for the development of medicines and medical devices based on clinical needs of patients.

Free Research Field

臨床試験