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

By Gareth MacDonald+

Last updated on 11-Sep-2015 at 15:45 GMT2015-09-11T15:45:24Z

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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