Nebie Eric I, van Eeuwijk Peter, Sawadogo Hélène N, Reus Elisabeth, Utzinger Jürg, Burri Christian
Swiss Tropical and Public Health Institute, Kreuzstrasse 2, CH-4123 Allschwil, Switzerland.
University of Basel, Petersplatz 1, CH-4003 Basel, Switzerland.
Trop Med Infect Dis. 2024 Feb 29;9(3):56. doi: 10.3390/tropicalmed9030056.
Medicine development is a lengthy endeavour. Increasing regulatory stringency and trial complexity might lead to reduced efficiency, dwindled output, and elevated costs. However, alternative models are possible. We compared the operational differences between pharmaceutical industry sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research. We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. The findings were triangulated with an online survey polling clinical research professionals. The operational differences were grouped under five categories: (i) trial start-up differences including governance and management structure; (ii) study complexity; (iii) site structural and organisational differences; (iv) study conduct, quality approaches, and standard operating procedures; and (v) site capacity strengthening and collaboration. Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance. Differences between the types of trials reviewed pertained to planning, operational complexities, quality approaches, and support to the sites. Integration of quality-by-design components has the potential to alleviate unnecessary process burden.
药物研发是一项漫长的工作。监管要求日益严格以及试验复杂性不断增加，可能会导致效率降低、产出减少和成本上升。然而，其他模式也是可行的。我们比较了制药行业赞助的试验、产品开发合作试验和研究者发起的试验之间的运作差异，以确定临床研究中低效率的关键驱动因素。我们与包括临床试验赞助商、合同研究组织和研究者在内的利益相关者开展了一项探索性混合方法研究。定性部分包括40次半结构化访谈、对12项研究的文献综述以及通过在布基纳法索、马里和瑞士的研究机构进行工作观察。研究结果通过对临床研究专业人员进行的在线调查进行三角互证。运作差异分为五类：（i）试验启动差异，包括治理和管理结构；（ii）研究复杂性；（iii）研究点的结构和组织差异；（iv）研究实施、质量方法和标准操作规程；以及（v）研究点能力加强和合作。研究点在规划阶段的早期参与以及量身定制的质量方法被认为对临床运作绩效至关重要。所审查的试验类型之间的差异涉及规划、运作复杂性、质量方法以及对研究点的支持。整合设计质量要素有可能减轻不必要的流程负担。
