An alternative remote consent model for UK clinical trials

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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.