While decentralised and hybrid trials are not necessarily a new way of conducting clinical research, the pandemic saw their demand increase massively out of necessity. Covid-19 has kickstarted a renewed focus on digitisation, especially in healthcare as strict lockdown restrictions disrupted the traditional ways of working and highlighted the need for safe, reliable and secure remote capabilities.
The past year has seen the research sector abuzz about decentralised clinical trials (DCTs) and their ability to cut costs, reduce the burden on patients and sites and collect more and better data.
Post-pandemic, the market is not short of DCT players but there are some that stand out in this increasingly saturated space.
Clinical Trials Arena profiles some of the exciting DCT movers and shakers paving their own way.
HUMA: a ‘hospital at home’
Huma’s virtual clinical trial solutions support the remote collection of patient-generated data from smartphones, wearables and sensors through phases of clinical development, post-approval research, real-world monitoring, and development of digital biomarkers, and companion products.
The firm, which was founded in 2011, operates across England, Germany and the UAE.
Its ‘hospital at home’ solution was deployed across more than 100 clinics in Germany in a single day, according to the company.
“We bring the hospital and research laboratory to the home by giving people ways to collect and share their real-time, real-world data through their smartphones. Clinicians prescribe the app to patients who can then share measurements like heart rate, oxygen levels, movement and symptoms,” said Huma CEO and founder Dan Vahdat in an interview with UK Tech News.
With Huma, clinicians get access to a dashboard of all their patients enabling them to flag any concerns and set up a video call to find out more. The same system is employed for participants to take part in clinical trials, facilitating research by remotely and continuously collecting patient-generated data.
The firm harnesses digital phenotyping and biomarkers captured from patients’ at-home data to provide more comprehensive, objective, and continuous pictures of human behaviour and function in both health and disease. Huma says this data is advancing predictive and personalised medicine and is improving the precision and speed of clinical trials.
During the pandemic, the firm focused some of its efforts to help look after Covid patients at home. The company is currently trialling its technology to cut NHS waiting lists by monitoring cardiac patients remotely so they can avoid unnecessary hospital visits.
In May 2021, Huma raised $130m dollars in Series C funding round led by Bayer’s Leaps and Hitachi Ventures.
Cloudbyz: built on the back of Salesforce
Founded in 2014 by Dinesh Sheshadri, Cloudbyz is an integrated clinical trial management solution (CTMS) built natively on the Salesforce cloud platform.
This month the firm announced the launch of its DCT solutions, which allow for improved digital capabilities throughout clinical trial lifecycles and include smart features such as remote monitoring, eConsent and virtual patient recruitment.
The cloud-based system has been tailored as an end-to-end answer for all clinical trial stakeholders and includes features for pre-screening of patients, recruitment of investigators, and monitoring study budget and payments.
By lowering data processing time and improving study administration these solutions aim to address the time and financial challenges of DCTs.
In April, Cloudbyz partnered with enterprise quality and safety management solutions (QMS and EHS) provider ComplianceQuest to offer a comprehensive platform for clinical research to enable “seamless collaboration, to improve efficiency and drive digital transformation in Life Sciences R&D”.
ConcertAI: AI-driven oncology research & RWE
Founded in 2017 by Romesh Wadhwani, Boston-based ConcertAI is a leader in real-world evidence (RWE) and patient outcomes technologies for the biopharmaceutical and healthcare industries.
Earlier this year ConcertAI struck a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. One of the first projects is looking at cardiovascular adverse events that occur in immuno-oncology patient populations.
ConcertAI champions improving racial diversity in clinical trials and has started a program called Engaging Research to Achieve Cancer Care Equity (ERACE).
“It brings together the latest data and technology along with top U.S. oncologists and cancer research centers to create a race- and ethnicity-based cancer registry,” said ConcertAI’s VP of scientific partnerships and customer success Warren A. Whyte.
“The registry is intended to expand our understanding of what is driving these inequalities, make it easier to innovate to create better health care outcomes for populations among which disparities exist, and support the next generation of researchers in their search for new solutions.”
In January 2020 the firm raised $150m in aggregate Series B financing.
Thread: harnessing social media to drive patient recruitment
Thread is a DCT start-up firmly grounded in patient-centricity.
In March 2021 the firm penned a partnership with CureClick, a community-powered platform that harnesses social media influencers to drive patient recruitment. The aim of the partnership is to engage social media influencers and patient advocates to accelerate recruitment for DCTs.
Influencers can combine Thread’s platform with CureClick’s more than 100,000 patient activists and advocates to highlight potentially life-saving DCTs within targeted social media networks. CureClick aims to enable trusted online community members to find and spread accurate information easily across their social networks, increasing clinical trial awareness and accelerating patient recruitment.
“We now have advocacy patient groups that are doing patient insights, which means they’re actually reviewing our technology and the protocols we’re supporting,” said Thread CEO John Reites in an interview with Clinical Trials Arena. “What we want to do is help to standardise and make it easier for them to unite through the communities they’re already using to connect potential participants directly into a decentralised study.”
Just prior to the partnership, Thread updated its DCT platform with a configurable, automated participant recruitment and onboarding platform where sponsors and CROs can create patient-facing websites. These websites guide potential participants through a simple automated recruitment and onboarding process.
Castor: allowing patient proactivity
Amsterdam and New Jersey-based Castor offers a cloud-based clinical data platform that simplifies and streamlines clinical trials processes. Founded by Derk Arts in 2011, Castor offers a self-service clinical research platform enabling researchers to design studies and integrate data from any source in real-time.
Patients are able to enrol themselves in trials and share their data online or via a mobile app. So far, the company has supported over 8,500 studies in more than 90 countries.
Last month, the company raised $45m in funding in a Series B financing round led by Eight Roads Ventures and F-Prime Capital.
The funds will go towards the development of software intended to scale up the company’s “direct-to-patients” approach globally. This new round brings its total funding to $65m.
The firm’s recently announced onboarding platform builds on the Castor eConsent tool and leads participants through the recruitment, screening, consent and enrolment processes.
The company says it aims to use the data it is collecting now to create simulated trial subjects by 2035.
Medidata: end-to-end DCT support
Medidata is one of the industry’s most established clinical trial technology firms and has pushed itself to the cutting-edge of DCT services. “We have been preparing ourselves for over 20 years to support the industry for what we have seen coming as the future of virtual trials,” the company’s senior vice president of clinical operations Medidata senior vice president of clinical operations Lisa Moneymaker told Clinical Trials Arena in July.
This year the company launched its DCT Program, aiming to provide a unified, end-to-end service that can accommodate multiple levels of trial decentralisation.
According to Medidata, the company is the first in the space to offer such an all-encompassing solution.
Medidata’s ‘Trial Dial’ enables sites, sponsors and CRO’s to customise their studies to be either fully site-based, fully virtual or somewhere on the spectrum between.
Alongside its DCT Program, the firm also launched myMedidata Registries, a patient-centred platform that allows for active patient participation and seeks to empower patients throughout their clinical trial journey and beyond.
Designed with Medidata’s Patient Insights Team, the platform gives patients continuous support in and out of a trial, with access to one portal for all their research needs.
An important feature of this platform is engaging patients post-trial to make them aware of other studies in which they could potentially enrol. “Post-trial, people who participate in clinical trials generally have really good experiences and they’re willing to participate again, but they’re often not asked. Sometimes they don’t even get a thank you note,” said Medidata vice president of patient registries and recruitment Kelly McKee.
“Patient data return is an emerging innovation right now, but even being asked to participate in another trial just isn’t happening. So, in that post-trial engagement, not only are you able to continue to engage with patients through data return, long-term follow-up and safety surveillance, you’re also able to provide individuals with opportunities to participate in follow-up studies or any other studies that may be of interest to them.”