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invivo-virtualclinicaltrials

 

The adjustments to normal life and business practices brought about by COVID-19 have reached into every niche, the effects in some areas being more immediately obvious than in others. The consequences are potentially far-reaching for developers of modern health care solutions.   

With the closing-off of some activities in the inpatient sector and the refocusing of hospital activity firmly on COVID-19 control measures, routine work on clinical trials has either halted or become severely restricted.

And just as the true value and potential of telehealth and remote patient care to assuring safe and high quality care has been demonstrated during the pandemic, so virtual clinical trials are getting a showcase that was unanticipated  ̶  but is proving to be highly useful.

UK-based Cambridge Cognition Holdings plc, a developer and marketer of digital solutions to assess brain health, is one of the few players active in the specialist field of virtual clinical trials for central nervous system (CNS) patients. CEO Dr Matthew Stork says this part of the health care industry is going through interesting times.  

Attention paid by the clinical trials world to virtual, real-time and at-home testing and treatment has been slowly increasing over the past few years. But in recent months, the benefits they offer have been put into sharp focus by COVID-19. “There are more conversations around experimental clinical trials, and more players doing them,” Stork said.

In the past, drug sponsors would have assessed their products in the clinic, but with some hospital activities having been shut off during COVID-19, many traditional clinical trials were postponed. Access for vulnerable patients has also been reduced. Unable to test their drugs, major pharma companies and biotechs alike faced up to either stopping their R&D or embracing contingency plans that involve virtual trials.

Companies trying out virtual studies are experiencing the benefits of improved data flow from virtual clinical trials and a richer knowledge for therapy development. While clinic-based trials can produce data at regular intervals, that does not happen multiple times a day. However, CNS disorders can have fluctuations in the disease state over a single day and on different days, Stork noted. “By continuously monitoring the treatment over time, you can track the disease and see the impact of that treatment,” he said. 

Wearable passive sensor technology was one of the drivers of digital virtual clinical trials, said Stork. Cambridge Cognition’s work in this area received much impetus after it worked on a project with Takeda Pharmaceutical Co. Ltd. in 2017 using the Apple Watch to develop app-based cognitive assessments. Cambridge Cognition was a joint venture partner on that project. 

The company’s work in this area has flourished since, and it has developed a suite of modules collecting a variety of data from patients at home or remotely. Medication reminders and at-home patient diaries are among the separate modules available. “We do the modules well,” said Stork, “but they are not unique; the unique part for us is collecting data that is meaningful and correlating it with another data set that is well known.” 

 

A Voice System Applied To Clinical Trials

Cambridge Cognition’s ongoing R&D on systems to measure clinical requirements has led it to develop a related program: a voice-based solution that collects data using voice, either via an app, or via a technique that makes a mobile phone give a reminder ring or a call to speak to the individual patient at certain times of the day.

“It’s an R&D program that has progressed to the point where it is already being used by a few big pharma companies to collect data in trials,” Stork said.  These methodological trials are showing that the technology works in a clinical environment. So far, data has been collected from 2,800 people, both healthy volunteers and patients with CNS disorders. 

The voice information is collected, patients are asked additional questions and the results are parsed. They run it through a cognitive neural network – an AI or machine learning tool that can assess for different levels of cognitive load. Stork explained, “We are looking at whether there are biomarkers for any particular disease state at present, and using the solutions in clinical trials through the voice app.”

Cambridge Cognition is at pre-production stage with the technology. It has a prototype that works but is not ready to use it in virtual trials yet. It expects that some virtual trials in the future would be a mixture of touch- and voice-based interactive elements. Stork added that the technology’s multiple speech recognition engines and predictive expectations of what people should typically say and their pattern of speech in a healthy state would give it a very high accuracy. 

The project has been running for two to three years, but still needs the necessary validation by regulators. But Cambridge Cognition sees a substantial market opportunity in the future. While several companies and universities are active in voice-based solutions, only one other company and one university are directly in the field of assessing cognition and working in clinical trials. 

Its expertise in CNS disorders was a key differentiator for Cambridge Cognition, said Stork. Another difference is its focus on providing advice, service and consultancy on how to measure cognition, rather than running trials with staff at hospital sites. Of a staff of 60, 15 have a Ph.D. “That’s a lot of people with secondary degrees,” said Stork.

The company uses its expertise to run seminars on a variety of clinical conditions. CSO Jenny Barnett, with Cambridge Cognition since 2008, is a frequent panel member at major conferences. Barnett led the R&D for Cambridge Cognition’s iPad-based medical device, CANTAB Mobile, which is used to test for the first signs of Alzheimer’s disease. 

 

A Digitally-Focused Ambition

Its combination of skills and expertise has elevated Cambridge Cognition to what Stork believes is the foremost company working in cognitive assessment in the world. “We want to continue that, and become the most digitally focused clinical trials company specializing in CNS disorders in the world,” he said. The company is “nicely on track” for that, with its four products: CANTAB assessments for cognition; the eCOA platform; digital health solutions for measuring cognition on a day-to-day basis; and now NeuroVocalix, for voice-based cognitive assessments.  

The company boasts a 100% satisfaction record with customers using its products. Collecting patient data from clinical trials was expensive and binary, said Stork. “We have a great track record, and get a lot of repeat customers, and old customers coming to us from their new companies.” 

Recent wins include two contracts worth a combined £1m ($1.23m) from companies wishing to shift from the traditional model of in-clinic assessments to technology-driven solutions that support testing subjects remotely. The first is for an entirely virtual trial designed to gain better understanding of the disease-burden for patients. Patients will complete electronic diaries on an Apple Watch and iPhone, and wear passive sensors to monitor electrodermal activity and heart rate.

The second is a Phase II study investigating the cognitive impact of a new drug for a neurodegenerative disorder. Patients’ experiences regarding motion and sleep will be collected remotely, mainly virtually, from smartphones, in order to enable high-frequency testing. The data will show natural daily variations and week-by-week disease progression.

 

More Than Software

Cambridge Cognition has validated, precise and reliable research software providing sensitive digital measures of cognitive function for all areas of brain research. “But we’re not just a technology company with nice software,” said Stork, pointing to its 20 years’ experience of clinical trials data and 280 clinical trials conducted. At any point in time, the company is running 50 trials to support patient state and disease progression research. Some 800 universities use CANTAB on a regular basis.

Although based in the UK, Cambridge Cognition only does around 10% of its business there. The balance shifts, but most of its revenue is earned in the EU and US. Its mainstream systems are available in 47 languages, as medtech and pharma companies need to test products anywhere in world. A recent trial was started in Iceland, in Icelandic.

The coming two to five years will be focused on growing core businesses in two markets: the $1bn electronic clinical outcomes assessments market; and the digital health market for CNS. In the eCOA market, 15% of clinical trials are in the area of CNS, which is a £150m that is growing at 20% a year. “There is a lot of growth in the market, with eCOA and digital and then voice,” Stork noted. 

Cambridge Cognition has had very good orders inflow this year, said the CEO. Year-on-year order intake in the first quarter of 2020 was up by 23%, and in the first half, four orders of over £500,000 each helped to increase order intake during the period by 88% to £4.9m, the company announced on 30 June. Contracted orders at that date were worth £7.5m.

Some of the growth is COVID-19 related, and while the fervent hope all round is that a second wave does not take hold later in the year, the digital approach to clinical trials has proven itself to be a valid alternative that should become more mainstream.

 

COVID-19 And Changed Attitudes To Technology

COVID-19 has changed attitudes to technology and in some cases moved customers away from their traditional comfort zones and towards digital tools. So after the pandemic started, Cambridge Cognition was able shift its focus to enable customers to continue their clinical trials as much as possible. Several switched to web-based testing, and there was a lot of interest in placing orders to run full virtual clinical trials.

As the pandemic winds out, clinical trials and assessments in clinics are starting up again now. The end of June and Q3 2020 are shaping up as the “restart.” However, in the search for immediate solutions, and to reduce the chances of similar delays in the future, pharmaceutical companies are showing greater interest in moving to virtual trials, said Stork. One legacy of COVID-19 is that even after the crisis has eased, the value of the virtual route for clinical trials has become more understood as a business option.

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