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利用虚拟技术开展炎症性肠病的临床试验。

Leveraging Virtual Technology to Conduct Clinical Trials in Inflammatory Bowel Disease.

作者信息

Noor Nurulamin M, Siegel Corey A

机构信息

Department of Gastroenterology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.

Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.

出版信息

Gastroenterol Hepatol (N Y). 2023 Aug;19(8):468-474.

Abstract

Clinical trials have led to major advances in inflammatory bowel disease (IBD) care over the last few decades, yet in that time most clinical trial protocols in IBD have remained markedly the same. Many IBD protocols often still require face-to-face visits and monitoring, hospital-based medication administration, paper-based forms and questionnaires, and short follow-up periods resulting in limited long-term data. These factors have recently been recognized as likely contributors to the low recruitment and lack of diversity of participants across clinical trials in IBD. However, with increasing technological advances, there is now an opportunity for improvement. This article assesses a range of virtual innovations for how they may offer digital solutions to challenges currently encountered in IBD clinical trials. Such solutions include consideration for increasing patient diversity, digital invitation, remote consent and recruitment, virtual visits, remote patient monitoring and data collection, remote medication delivery and administration, remote clinical trial monitoring, and routinely collected health data for long-term follow-up. Adoption of virtual technology may drive the field toward patient centricity and more efficient trial protocols to allow for a new era in IBD clinical trials.

摘要

在过去几十年里,临床试验推动了炎症性肠病(IBD)治疗的重大进展,但在此期间,IBD的大多数临床试验方案基本保持不变。许多IBD方案通常仍需要面对面就诊和监测、在医院给药、纸质表格和问卷,以及随访期较短,导致长期数据有限。这些因素最近被认为可能是IBD临床试验招募率低和参与者缺乏多样性的原因。然而,随着技术的不断进步,现在有了改进的机会。本文评估了一系列虚拟创新,探讨它们如何为IBD临床试验目前遇到的挑战提供数字解决方案。这些解决方案包括考虑增加患者多样性、数字邀请、远程同意和招募、虚拟就诊、远程患者监测和数据收集、远程药物递送和给药、远程临床试验监测,以及用于长期随访的常规收集的健康数据。采用虚拟技术可能会推动该领域以患者为中心,并采用更高效的试验方案,从而开启IBD临床试验的新时代。

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