Eichler Hans-Georg, Sweeney Fergus
European Medicines Agency, London, UK.
Clin Trials. 2018 Feb;15(1_suppl):27-32. doi: 10.1177/1740774518755058.
The authors describe key challenges facing the clinical trials community and propose solutions to these issues, including the role the Clinical Trials Transformation Initiative can play in addressing these issues. Specifically, the authors reflect on clinical trial globalization and the harmonization of frameworks and requirements across regions; the challenges associated with balancing the desire for external validity, pragmatic trials, and precision medicine; clinical trial transparency; and operational complexity and the expense of clinical trials. By addressing these challenges, future clinical trials will be more feasible, relevant, and credible, and support both the continuing altruistic contributions of patients and the collection of more meaningful data.
作者描述了临床试验界面临的关键挑战，并提出了针对这些问题的解决方案，包括临床试验转型倡议在解决这些问题中可以发挥的作用。具体而言，作者思考了临床试验全球化以及跨地区框架和要求的协调统一；在平衡外部有效性、务实试验和精准医学需求方面所面临的挑战；临床试验透明度；以及操作复杂性和临床试验成本。通过应对这些挑战，未来的临床试验将更可行、更具相关性和可信度，并支持患者持续的利他贡献以及收集更有意义的数据。
