Why technology holds the key to a revolution in clinical trials
Clinical trials, particularly those involved in finding a Covid-19 vaccine, have never been so crucial in getting society back onto some sort of even keel. Yet they’ve also never been in such a state of transformation.
Scientists and pharmaceutical companies are racing to get coronavirus drugs into the hands of those who need them most. There is pressure from all sides to speed up a process that is, notoriously and understandably, slow moving, at the same time the whole world is scrutinising every minor detail of the industry’s response to the pandemic.
Meanwhile, thousands of clinical trials – many of which are investigating treatments for life-threatening diseases such as cancer and Alzheimer’s – have been put on hold. With expertise being funnelled elsewhere to tackle the crisis at hand.
Just as it has done so in many areas, the key to resolving these seeming contradictions lies in technology, and Covid-19 may finally be the catalyst needed to help this industry fully and properly embrace it.
Out with the old
Until now, the pharmaceutical industry has been cautious to disrupt or change the clinical trial status quo that’s largely relied on paper and manual entry for decades. Paper is seen as more secure when handling patient data; less at risk of being hacked or breached. It’s seen as more cost-effective – no software fees, no data entry training, no need for specialist skills. It’s also part of an entire regulatory system built on paper and, for the most part, it’s worked. Or at least it did until the coronavirus took hold.
Now, faced with shifting demands and behaviours, lockdowns, and a looming recession, these traditional ways of working no longer cut it. Not in terms of patient data, not in terms of cost and not when regulatory approval is needed much faster and across international borders in ways never seen before.
Why technology holds the key
Trials that may have lasted years are being fast-tracked to be completed within months, at the same time existing trials are being shut down. These changes not only put time pressures on people collecting and analysing the data, but it puts financial pressures on pharma groups, sponsors and the industry.
Recruiting patients has become difficult. People are less inclined to take part in trials, or any activities for that matter, that aren’t essential to their everyday life and the advertising of such trials – in hospitals and doctor’s surgeries – just aren’t being seen. In fact, surveys indicate that, at the peak of the pandemic in April 2020, new patients entering clinical trials dropped to ~25% of pre-Covid-19 levels.
This has seen technologies that were somewhat kept at arm’s length or tentatively used, being fully embraced. The adoption of existing technologies – the likes of ePro, eCOA, eCRF and eConsent – as well as new apps and software that had been expected to take years to bed in, have taken six months. The money that was needed to onboard these technologies is seen as a must-have rather than a nice-to-have.
The FDA and EMA have moved fast to issue guidance on clinical trials affected by Covid-19; relaxing rules such as allowing protocol amendments and encouraging sponsors to offer virtual patient visits.
These dynamics have also created strong incentives for pharmaceutical company executives to look for technology solutions to address such challenges. Many of the life science software companies in our portfolio tell of a flurry of interest from pharmaceutical companies and CROs who are now reviewing new technologies to see whether there is anything they should be deploying immediately.
In our portfolio alone, Umotif’s suite of electronic patient data capture tools has seen a surge in demand from existing and new customers. Cisiv, which provides a flexible platform for decentralised trials (EDC, eConsent, eCOA, ePRO) is seeing strong interest from contract research organisations and sponsors.
While Raremark helps find and remotely work with patients with rare diseases. These patients would typically be hard to reach and support and the company is reporting strong demand from rare disease-focused pharmaceutical companies.
We have been investing in digital health for the best part of a decade. Never has the pace of change been more rapid. Suddenly, the wider digitisation of the industry that has been slowly burning for decades is in full flame. It’s taken Covid-19 to finally align the needs of pharmaceutical companies, regulators and governments in using technology to solve many of the problems the industry has had, and many that it faces going forward.
The hope is that the longer term opportunities technology offers to improve patient recruitment, clinical trial conduct, data capture and time to market mean that the changes we’re seeing now are here to stay.
By Christoph Ruedig, AlbionVC Partner
Originally published in European Pharmaceutical Manufacturer