An alternative remote consent model for UK clinical trials

参与者对临床试验的参与度正在下降。超过80%的临床试验达不到招募目标，只有3%-5%的合格参与者因试验地点而登记参加试验，然后30%的人因参加太过繁重而退出试验。我们今天的生活越来越数字化，但英国临床试验行业一直未能提供人们期望从非医疗保健行业获得的无缝体验和数字便利。临床试验对我们来说很重要，能够为患者带来新的治疗方法，如果没有参与者参与临床试验，我们就无法做到这一点。虚拟临床试验，参与者永远不必访问试验现场，有机会通过使用远程医疗平台来改变格局。在英国采用虚拟临床试验的一个明显障碍是缺乏成本效益高和简化的虚拟知情同意程序。该项目的主要目标是开发一种低成本和有效的虚拟知情同意解决方案。次要目标是：通过改善可访问性提高临床试验的多样性和包容性，使各行各业的人都能参与研究；减少临床试验的碳足迹；吸引美国以外的赞助商到英国进行虚拟临床试验。开发我们流程的主要重点领域将是使用一种强大的、市场可访问的工具，以一种复制传统纸质流程的方式，并可以将成本保持在非常低的水平。许多数字技术公司开发的电子同意平台与传统的纸质同意流程非常不同，但这些平台成本很高，而且数据安全方面的风险很大。我们的流程将是新颖的，因为它以经济高效的方式增强了当前的临床试验同意流程，并确保通过一个电子签名和数字交易管理的全球标准的系统来满足严格的数据隐私和安全要求。

Participant engagement in clinical trials is decreasing. More than 80% of clinical trials miss their recruitment goals, only 3-5% of all eligible participants enrol in a trial due to its location, and then 30% drop out because taking part is too burdensome. Our lives today are increasingly digital, but the UK clinical trials Industry hasn't been able to deliver the seamless experience and digital conveniences that people have come to expect from non-health care industries. Clinical trials are important for us to be able to bring new treatments to patients and without participants engaging in clinical trials, we cannot do this.Virtual clinical trials, where participants never have to visit a trial site, have an opportunity to change the landscape by using telemedicine platforms. One clear barrier to the uptake of virtual clinical trials in the UK is the lack of a cost effective and streamlined process for virtual informed consent.The primary objective of this project is to develop a low-cost and effective solution for virtual informed consent. The secondary objectives are: improve diversity and inclusion in clinical trials through improved accessibility that enables people from all walks of life to participate in research; reduce the carbon footprint of clinical trials; attract Sponsors away from the US to the UK to run their virtual clinical trials.The main area of focus for developing our process will be to use a robust, market accessible tool in a way that replicates the traditional paper based process and can keep costs very low.There are many digital technology companies developing electronic consent platforms that are very different to the traditional paper-based consent process, but these come at a high cost and considerable risk for data security concerns. Our process will be novel because it enhances current clinical trial consenting processes in a cost-effective way and ensure strict data privacy and security requirements are met via a system that is the global standard for electronic signatures and digital transaction management.