Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey

Frontiers in Medicine

Medicine

Jean-Marc Hoffmann¹  Regina Grossmann¹  Henry Yau²  Anette Blümle³  Britta Lang³  Cedric Bradbury³ 

[1] Clinical Trials Center, University of Zurich and University Hospital Zurich, Zurich, Switzerland;Clinical Trials Centre, The University of Hong Kong, Pokfulam, Hong Kong SAR, China;Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany;

关键词: international harmonization;    GCP;    quality management;    clinical research;    academic research;    organizational efficiency;    university hospitals;   

DOI  :  10.3389/fmed.2023.1252352

 received in 2023-07-03, accepted in 2023-09-25,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundClinicians around the world perform clinical research in addition to their high workload. To meet the demands of high quality Investigator Initiated Trials (IITs), Clinical Trial Units (CTUs) (as part of Academic Research Institutions) are implemented worldwide. CTUs increasingly hold a key position in facilitating the international mutual acceptance of clinical research data by promoting clinical research practices and infrastructure according to international standards.AimIn this project, we aimed to identify services that established and internationally operating CTUs – members of the International Clinical Trial Center Network (ICN) – consider most important to ensure the smooth processing of a clinical trial while meeting international standards. We thereby aim to drive international harmonization by providing emerging and growing CTUs with a resource for informed service range set-up.MethodsFollowing the AMEE Guide, we developed a questionnaire, addressing the perceived importance of different CTU services. Survey participants were senior representatives of CTUs and part of the ICN with long-term experience in their field and institution.ResultsServices concerning quality and coordination of a research project were considered to be most essential, i.e., Quality management, Monitoring and Project management, followed by Regulatory & Legal affairs, Education & Training, and Data management. Operative services for conducting a research project, i.e., Study Nurse with patient contact and Study Nurse without patient contact, were considered to be least important.ConclusionTo balance the range of services offered while meeting high international standards of clinical research, emerging CTUs should focus on offering (quality) management services and expertise in regulatory and legal affairs. Additionally, education and training services are required to ensure clinicians are well trained on GCP and legislation. CTUs should evaluate whether the expertise and resources are available to offer operative services.

【 授权许可】

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Copyright © 2023 Hoffmann, Blümle, Grossmann, Yau, Lang and Bradbury.