Diabetologia ( IF 8.4 ) Pub Date : 2022-07-29 , DOI: 10.1007/s00125-022-05762-x Jan W Eriksson 1 , Björn Eliasson 2, 3 , Louise Bennet 4, 5 , Johan Sundström 6, 7
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This narrative review describes a new approach to navigation in a challenging landscape of clinical drug development in diabetes. Successful outcome studies in recent years have led to new indications and guidelines in type 2 diabetes, yet the number of clinical trials in diabetes is now declining. This is due to many environmental factors acting in concert, including the prioritisation of funding for other diseases, high costs of large randomised clinical trials, increase in regulatory requirements and limited entry of novel candidate drugs. There is a need for novel and cost-effective paradigms of clinical development to meet these and other challenges. The concept of registry-based randomised clinical trials (RRCTs) is an attractive option. In this review we focus on type 2 diabetes and the prevention of cardiovascular and microvascular comorbidities and mortality, using the Swedish SMARTEST trial as an example of an RRCT. We also give some examples from other disease areas. The RRCT concept is a novel, cost-effective and scientifically sound approach for conducting large-scale diabetes trials in a real-world setting.
Graphical abstract
中文翻译：
基于登记的随机临床试验：基于证据的糖尿病护理的补救措施？
这篇叙述性综述描述了一种在糖尿病临床药物开发充满挑战的环境中导航的新方法。近年来成功的结果研究为 2 型糖尿病带来了新的适应症和指南，但目前糖尿病临床试验的数量正在下降。这是由于许多环境因素共同作用，包括优先资助其他疾病、大型随机临床试验的高成本、监管要求的增加以及新候选药物的进入受限。需要新颖且具有成本效益的临床开发范例来应对这些和其他挑战。基于注册的随机临床试验 (RRCT) 的概念是一个有吸引力的选择。在这篇综述中，我们使用瑞典 SMARTEST 试验作为 RRCT 的一个例子，重点关注 2 型糖尿病以及心血管和微血管合并症和死亡率的预防。我们还举了一些其他疾病领域的例子。RRCT 概念是一种新颖、具有成本效益且科学合理的方法，用于在现实环境中进行大规模糖尿病试验。
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