Hoffmann Jean-Marc, Blümle Anette, Grossmann Regina, Yau Henry, Lang Britta, Bradbury Cedric
Clinical Trials Center, University of Zurich and University Hospital Zurich, Zurich, Switzerland.
Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Front Med (Lausanne). 2023 Oct 12;10:1252352. doi: 10.3389/fmed.2023.1252352. eCollection 2023.
Clinicians 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.
In 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.
Following 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.
Services concerning quality and coordination of a research project were considered to be most essential, i.e., , and , followed by , and . Operative services for conducting a research project, i.e., and , were considered to be least important.
To 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.
世界各地的临床医生在承担繁重工作的同时还要开展临床研究。为了满足高质量研究者发起的试验（IIT）的需求，全球范围内都设立了临床试验单位（CTU）（作为学术研究机构的一部分）。CTU通过按照国际标准推广临床研究实践和基础设施，在促进临床研究数据的国际相互认可方面日益占据关键地位。
在本项目中，我们旨在确定已设立且在国际上运营的CTU（国际临床试验中心网络（ICN）的成员）认为对确保临床试验顺利进行同时符合国际标准最为重要的服务。我们的目标是通过为新兴和不断发展的CTU提供一个资源，以明智地建立服务范围，从而推动国际协调统一。
按照AMEE指南，我们编制了一份问卷，涉及不同CTU服务的感知重要性。调查参与者是CTU的高级代表，也是ICN的一部分，在其所在领域和机构拥有长期经验。
与研究项目质量和协调相关的服务被认为是最必不可少的，即……，其次是……以及……。开展研究项目的操作服务，即……和……，被认为是最不重要的。
为了在满足临床研究的高国际标准的同时平衡所提供的服务范围，新兴的CTU应专注于提供（质量）管理服务以及监管和法律事务方面的专业知识。此外，还需要教育和培训服务，以确保临床医生接受良好的GCP和法规培训。CTU应评估是否具备提供操作服务的专业知识和资源。
