von Niederhäusern Belinda, Magnin Annette, Pauli-Magnus Christiane
Clinical Trial Unit, Department of Clinical Research, University and University Hospital Basel, Switzerland.
Swiss Clinical Trial Organisation, Bern, Switzerland.
Swiss Med Wkly. 2018 Apr 26;148:w14615. doi: 10.4414/smw.2018.14615. eCollection 2018.
A prominent 2014 series by The Lancet on "Increasing value, reducing waste in biomedical research" provided recommendations on how to optimise precious resources, including in clinical research. Despite being ideally placed to lead the movement in patient-oriented clinical research, academia struggles to take corresponding measures and find ways to evaluate their impact. A decade ago, Swiss stakeholders established constructive initiatives to improve the quality of clinical research, including a national Clinical Trial Unit (CTU) Network, predominantly rooted in university hospitals. At the 10th anniversary of this network (2007-2017), we reflect on the CTUs' trajectory and review whether - and how - they have been successful in improving the value of clinical research conducted in Switzerland. Anonymised surveys with involved clinical research stakeholder institutions and CTU customers at university hospitals suggest that the CTU Network has positively influenced the quality of academic clinical research. Future goals should include standardised education on Good Clinical Practice; the establishing of an audit function; the positioning of the network as an "entrance gate" for international trials; and support for young scientists launching their careers. Although stakeholder feedback has been very positive, praise does not constitute a standardised measure of the actual impact of CTU services. Beyond that, a broad understanding and practical guidance on how to increase value in academic clinical research are still lacking. We conclude with ways forward, including "INcreasing QUality In clinical Research" (INQUIRE), a comprehensive framework for the practical assessment of quality in academia developed by the CTU Basel. INQUIRE, founded on consensus across international and Swiss stakeholders, outlines six key quality dimensions to be fulfilled study-wide and is available for all relevant parties involved. INQUIRE encourages academic institutions to adopt waste-reducing strategies and strives to build an evidence-based clinical research landscape in Switzerland, with national and international influence.
《柳叶刀》2014年发表的一篇关于“提高生物医学研究价值、减少浪费”的重要系列文章提出了如何优化宝贵资源的建议，包括临床研究方面。尽管学术界在以患者为导向的临床研究中处于引领地位，但在采取相应措施并找到评估其影响的方法方面仍面临困难。十年前，瑞士的利益相关者发起了建设性倡议以提高临床研究质量，包括建立一个主要扎根于大学医院的国家临床试验单位（CTU）网络。在该网络成立10周年之际（2007 - 2017年），我们回顾CTU的发展轨迹，并审视它们在提高瑞士临床研究价值方面是否成功以及如何成功的。对大学医院参与临床研究的利益相关者机构和CTU客户进行的匿名调查表明，CTU网络对学术临床研究质量产生了积极影响。未来目标应包括开展关于良好临床实践的标准化教育；建立审计职能；将该网络定位为国际试验的“入口”；以及支持年轻科学家开启职业生涯。尽管利益相关者的反馈非常积极，但赞扬并不构成对CTU服务实际影响的标准化衡量。除此之外，对于如何提高学术临床研究价值仍缺乏广泛的理解和实践指导。我们最后提出了前进的方向，包括巴塞尔CTU开发的“提高临床研究质量”（INQUIRE），这是一个用于对学术界质量进行实际评估的综合框架。INQUIRE基于国际和瑞士利益相关者的共识，概述了在整个研究中要满足的六个关键质量维度，可供所有相关方使用。INQUIRE鼓励学术机构采用减少浪费的策略，并努力在瑞士建立一个具有国内和国际影响力的循证临床研究格局。
