UK clears first use of e-consent tech in clinical trial

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Clinical trial, Informed consent

UK HRA approves 1st clinical trial using e-informed consent tech
UK HRA approves 1st clinical trial using e-informed consent tech
A drugmaker trialling an autoimmune disease treatment in the UK has been cleared to use electronic informed consent by the National Health Service (NHS).

The UK Health Research Authority (HRA) – a division of the NHS established in 2011 to “streamline” drug research - approved use of Mytrus’ Enroll platform in a clinical trial of an undisclosed autoimmune disease drug candidate this week.

The decision – which is the first time e-informed consent has been cleared in the UK – is testament to cost and time savings possible according to a Mytrus spokeswoman, who told us “increased access to monitoring information makes centralized monitoring more efficient which leads to lower costs and a more ethical balance for patient protections.

She added that: “There are savings in site management, reduced regulatory findings, more consistent training, much better sponsor access to information and more” ​and stressed that better informed patients are less likely to drop out of research.

Mytrus declined to specify how much sponsors stand to save using e-informed consent, however, the spokeswoman stressed that: “We do try to pass along to clients as much of the efficiency gains as we can​.”

e-informed consent 

In March, the US Food and Drug Administration (FDA) issued guidance​ explaining how drug companies should use e-informed consent in clinical trials, and stating that the approach will improve participants “ability to retain and comprehend information​.”

The backing marked a significant milestone for the e-informed sector, which has been growing since Pfizer launched its REMOTE study with four tech partners – including Mytrus – in 2011.

Although the Pfizer study was unsuccessful – the US drugmaker failed to find sufficient patients to take part – it set the ball rolling for Mytrus, which has since stressed the potential benefits of the approach in various studies​. 

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