Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey
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 ke...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-10-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1252352/full |
| _version_ | 1827794674459344896 |
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| author | Jean-Marc Hoffmann Anette Blümle Regina Grossmann Henry Yau Britta Lang Cedric Bradbury |
| author_facet | Jean-Marc Hoffmann Anette Blümle Regina Grossmann Henry Yau Britta Lang Cedric Bradbury |
| author_sort | Jean-Marc Hoffmann |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T18:37:15Z |
| format | Article |
| id | doaj.art-cce963ba77e24c34a1b60b67376e9a3b |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-11T18:37:15Z |
| publishDate | 2023-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-cce963ba77e24c34a1b60b67376e9a3b2023-10-12T16:49:53ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-10-011010.3389/fmed.2023.12523521252352Toward a global harmonization of service infrastructure in academic clinical trial units: an international surveyJean-Marc Hoffmann0Anette Blümle1Regina Grossmann2Henry Yau3Britta Lang4Cedric Bradbury5Clinical Trials Center, University of Zurich and University Hospital Zurich, Zurich, SwitzerlandClinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, GermanyClinical Trials Center, University of Zurich and University Hospital Zurich, Zurich, SwitzerlandClinical Trials Centre, The University of Hong Kong, Pokfulam, Hong Kong SAR, ChinaClinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, GermanyClinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, GermanyBackgroundClinicians 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.https://www.frontiersin.org/articles/10.3389/fmed.2023.1252352/fullinternational harmonizationGCPquality managementclinical researchacademic researchorganizational efficiency |
| spellingShingle | Jean-Marc Hoffmann Anette Blümle Regina Grossmann Henry Yau Britta Lang Cedric Bradbury Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey Frontiers in Medicine international harmonization GCP quality management clinical research academic research organizational efficiency |
| title | Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey |
| title_full | Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey |
| title_fullStr | Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey |
| title_full_unstemmed | Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey |
| title_short | Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey |
| title_sort | toward a global harmonization of service infrastructure in academic clinical trial units an international survey |
| topic | international harmonization GCP quality management clinical research academic research organizational efficiency |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1252352/full |
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