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COVID-19 – a catalyst for technology adoption in clinical trials

As the COVID-19 crisis disrupts clinical trials around the globe, it is also proving to be a catalyst that may transform its approach to trials for good

The COVID-19 crisis has disrupted clinical trials around the globe, many of which are investigating treatments for life-threatening diseases such as cancer.

At a time when the whole world is closely scrutinising the pharma industry’s ability to respond to the pandemic, COVID-19 is proving to be a catalyst that may transform its approach to trials for good.

For good reason, the pharmaceutical industry is cautious with new approaches and, critics would say, has been slow to adopt technology throughout clinical trials. Often, the biggest competitor to automation is still paper. COVID-19 has presented the clinical trial industry with considerable short-term challenges, which threaten a large proportion of pharmaceutical companies’ drug development programmes with delays and cost overruns, and which are forcing changes to methods of setting up and conducting clinical trials.

Many of these changes involve the use of technology, both software and hardware. What’s impressive is the speed of adoption of some of

the new technologies, something that would have been unthinkable only six months ago and that has been facilitated to some extent by regulators and governments working hard to update their guidance.

The hope is that the longer-term opportunities that 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.

‘Same old’ is not good enough anymore

In the last five to ten years there has been a marked increase in the adoption of novel technologies for clinical trials. Most trials are now using electronic data capture and acronyms such as eCOA, eCRF and eConsent have become standard terminology. What has happened in the pharmaceutical industry is not dissimilar to what has happened in the healthcare provider industry, which has seen record- keeping move from paper to digital with a near 100% penetration of electronic health records in the developed world.

As an aside, this digitisation was brought about by governments providing significant monetary incentives to hospitals for the adoption of electronic health records and sometimes significant fines for non-compliance, for example through the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act in the US. Yet, this digitisation hasn’t led to the expected gains in terms of efficiency and outcomes, neither for the providers, nor the pharmaceutical industry. What’s more, large parts of the clinical trial process remain paper-based and/or manual.

For example, 70% of clinical trials still use paper-based patient-reported outcomes, even though ePRO has been around for more than a decade. The reasons for this are well understood: a strict regulatory framework, a relentless focus on timely achievement of clinical development milestones and market authorisation approval. These same reasons are now proving to be a catalyst for technology adoption during the COVID-19 pandemic.

An industry in crisis

As COVID-19 struck and countries went into lockdown, patient visits to healthcare providers dropped dramatically for two main reasons.
Firstly, provider resources were reallocated away from routine care to COVID-19 cases or preparation. Secondly, many patients were staying away from healthcare facilities, either of their own accord or because they were being told to do so by authorities.

In many badly affected countries, non-urgent care has been virtually suspended for months. Hospitals in the US, which derive much of their profits from elective surgical procedures, have been badly affected financially. As lockdowns were being reversed, healthcare facilities started opening again, however many patients are still avoiding a visit to the doctor unless absolutely necessary.

As hopes of finding a vaccine or other cure for large parts of the population for the 2020/21 winter season fade away, it’s becoming clear that the pandemic won’t go away quickly and that healthcare systems will have to work in this ‘new normal’ for some time still.

During the height of the lockdown, most clinical trial sites were shut down, although many are now slowly reopening. Those that are open are still facing challenges recruiting patients. Surveys indicate that, at the peak of the pandemic in April 2020, new patients entering clinical trials had dropped to ~25% of pre-COVID-19 levels, whereas in July 2020, activity was back to ~70% of normal.

There has been an explosion of clinical trials in relation to treating COVID-19, however despite their publicity, the actual share is very small (as of 9 September 2020, listed 1,785 actively recruiting COVID-19 trials vs. 56,098 actively recruiting trials in total) and we don’t expect them to have a meaningful impact on industry-wide metrics.

With the delays suffered to date and the scrutiny by investors and other stakeholders of clinical development programmes, pharmaceutical companies are keen to accelerate clinical trials as sites are re-opening. Industry experts in our network expect a bow wave of trials attempting to start soon, which may result in bottlenecks that could compound the problem.

Change is on the horizon

The world is currently conducting the biggest home working experiment in history. This has forced many industries and authorities to change practices, including pharmaceutical companies and their regulators. Products such Zoom and Microsoft Teams have demonstrated that it is perfectly feasible to conduct many activities virtually, with all the associated distancing and efficiency benefits.

The fact that many routine patient consultations have moved online in response to the pandemic has not gone unnoticed to the pharmaceutical industry. In response to the pandemic, 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 virtualise patient visits.

Our experience suggests regulators are ambivalent about technology and highly supportive of anything that can increase standards of patient safety.Coupled with the clinical trial issues discussed above, these dynamics have created strong incentives for pharmaceutical company executives to look for technology solutions to address the challenges currently facing them.

Many of the life sciences software companies in our portfolio and others we have been speaking to 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. Sales cycles for technology vendors in the industry seem to have shortened considerably.

Partly driven by the move to virtual meetings, software and technology vendors are reporting better access to more senior pharmaceutical company executives, who now take time to engage and focus their attention on new technologies. It helps that software vendors can effectively demo their products through video conferencing without travel and scheduling challenges slowing them down.

There’s talk of entire industries, such as travel and transportation, being changed for good as a result of COVID-19. The hope is that the technologies that are helping the pharmaceutical industry address the impact of the crisis on clinical trials are here to stay, and that clinical trial technology will move up the agenda and into the boardrooms of every pharma company around the globe.

Which technologies will win?

While many life sciences software companies have seen a temporary decrease in revenues at the peak of the pandemic in the developed world due to the general decline in business activity, many feel bullish about the longer-term prospects. One only needs to look at the stock market valuations of companies such as Veeva to see the optimism the market and investors have about the industry – its share price had more than doubled at the time of writing since the trough in mid-March 2020.

We believe that companies offering the tools that enable decentralised, virtual or site-less trials, remote patient engagement and data capture will be the ones benefiting most from the changes the clinical trial industry is undergoing. For example, uMotif, a company in the AlbionVC portfolio with a suite of electronic patient data capture tools for real-world and interventional clinical research, has seen a surge in demand from existing and new customers.

Another example is our portfolio company Cisiv, which provides a flexible platform for decentralised trials (EDC, eConsent, eCOA, ePRO) for real-world research settings and which is seeing strong interest in its solutions from contract research organisations and sponsors.

Finally, Raremark, another AlbionVC portfolio company with a novel patient engagement technology enables the finding and remote engagement of rare disease patients. These patients are hard to reach in normal times and so the company is reporting strong demand from rare disease- focused pharmaceutical companies that are keen to continue to engage with its target patient populations.

We have been investing in digital health for the best part of a decade. Never has the pace of change been more rapid. The COVID-19 pandemic is a major crisis and a tragedy for many. For forward-thinking technology vendors, it presents a significant opportunity to help catapult the life sciences industry into the future.

Christoph Ruedig is a partner at AlbionVC

23rd October 2020

Christoph Ruedig is a partner at AlbionVC

23rd October 2020

From: Research



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