Empatica
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Using technology to decentralize clinical trials

Clinical trials are an essential component of medical research and treatment development, but the disruptions caused by COVID-19 have revealed how their design, conduct, and reporting could be improved, streamlined, and modernized, in ways that would benefit patients, practitioners, and all research outcomes [1].

According to The Lancet, [1] thousands of trials have been suspended or stopped, due to the difficulties presented by lockdown conditions, as well as the need to prioritize patient safety. However, other ongoing trials shifted to a decentralized (or remote) model, enabling them to carry on despite the adversity. This shift was rightfully encouraged by the US Food and Drug Administration (FDA) when earlier this March 2020 (and revised again in July), the agency issued guidance on protecting patient safety during the COVID-19 pandemic. The FDA guidelines called on researchers and trial sponsors to “consider optimizing use of central and remote monitoring programs to maintain oversight of clinical sites, if planned on-site monitoring visits are no longer possible” [2].

While in conventional clinical trials patients are expected to go to a hospital or clinic multiple times during a trial, decentralized clinical trials utilize telemedicine for remote patient visits and digital devices to engage with patients and collect data in real-time from the comfort of their homes.

Besides reducing trial timelines and costs, decentralized trials enhance recruitment, compliance, provide more patients with access to investigational therapies, while also generating more data to inform scientific understanding [3].

How decentralized trials can keep running during COVID-19

The benefits of using technology in trials were already present before COVID-19, but without the ability to collect patient data in person, and on-site, the potential of wearables alongside virtual trial platforms became all the more prominent.

Virtual trial platforms that utilize wearable sensors can not only help keep trials running, but can also enhance their effectiveness in a range of ways:

  • Maintaining patient safety by lowering time on-site and reducing the amount of in-person visits needed
  • Increasing the amount and diversity of data collected, especially if the sensor used is able to perform continuous data collection and can stream this data from multiple sites and geographies
  • Getting patients set up without requiring them to leave their homes, via remote enrollment through an online platform
  • Enhancing participation by seamlessly collecting data from patients no matter where they are, since wearable technology can offer a smoother and easier user experience

Meeting the needs of the post-pandemic world

This year, when the COVID pandemic hit, Empatica was very fortunate to have already employed an ecosystem powered by wearable sensors, able to continuously stream raw physiological data to a user app and then to a cloud platform. Building on our Embrace for Research platform, we created Empatica Care, a remote monitoring platform that can work across both of our key research wearables.

The Empatica ecosystem is comprised of three tools:

  • A medical-grade wearable. Both the E4 and the Embrace2 have been used in clinical trials and academic studies. A third device, the EmbracePlus, is currently under development. The sensors packaged in these wearables continuously measure physiological parameters, giving insights into sleep, activity, autonomic arousal, and seizures for many different typologies of clinical/research studies. Their comfortability and attractive design were conceived to improve subject recruitment, retention, and compliance.
  • A user app. The Mate App provides secure and reliable data transfer and visualization, also functioning as an e-diary. Subjects can mark relevant events as directed by the study, providing daily insights for understanding subjective outcomes. A unique identifier also ensures that the subject’s data is partitioned correctly and stored securely.
  • A cloud platform. All physiological data stored in MATE is automatically uploaded to Empatica’s cloud platform, the Research Portal, using the smartphone’s internet connection. The Research Portal allows research teams, CRO personnel, and study coordinators to manage investigations, check compliance, manage multiple sites, and collect data from different types of clinical and longitudinal research studies, all within one platform.

With this ecosystem in place, we started working with different Pharma companies and CRO’s, such as Takeda and Cambridge Cognition, and were able to quickly pivot to create more visibility around the data collected.

By improving the compliance matrix, we gave CROs and site coordinators the ability to understand in real-time how patients are wearing the device, so they can reach out promptly if, for instance, they’re not wearing it properly. Most importantly, the platform allows them to be informed in real-time on the patients’ vitals.

The importance of digital endpoints

Over the past few years, we have witnessed the large adoption of digital endpoints both in the healthcare and pharmaceutical space.

The adoption of digital endpoints can offer objective data derived from accurate measurements, while also benefiting patients. The nonprofit Digital Medicine Society offers a library of digital endpoints already used by pharmaceutical companies in their trials, and this list is bound to grow. [4]

Digital biomarkers, collected via wearable sensors, can replace traditional measures while offering higher accuracy, and a holistic patient view. Some of the biomarkers that are collected by our devices are heart rate and heart rate variability, respiratory rate, oxygen volume in blood or pulse oximetry, signals from the nervous system, peripheral temperature, levels of activity, and rest.

Enhancing trial efficiency, beyond Covid

The COVID-19 pandemic has shown how valuable the adoption of virtual trial platforms has been in ensuring the continuity of clinical trials in a decentralized manner.

And we believe that the adoption of the same technology will be beneficial beyond the COVID-19 era. Here’s why:

  • By allowing for continuous capture of all physiological data, rather than merely offering a snapshot matrix, Empatica’s ecosystem can provide a more holistic view of the patients.
  • Clinical investigations need to rely on scientific rigor. Among the hundreds of smart device companies that promise to measure vital signs, only a handful focuses on the believability and traceability of the data. Empatica is one of them.
  • Our ecosystem is designed to empower CRO’s and Pharma companies with full visibility on the raw data, which allows them to potentially run a new algorithm retrospectively.
  • Empatica has earned both FDA clearance and CE marking, fulfilling the requirement of data provenance by regulators in US and Europe. Engaging with regulatory entities in the early stage of a trial allows bolstering the endpoints that are already been used or, in some case, to replace some of them.
  • Remote trial management platforms can contribute to the alleviation of clinical trial costs.

Empatica technology is trusted by thousands of partners to empower their investigations: among them are NEC and Sunovion. NEC is currently developing a technology that accurately estimates chronic stress [5] based on the physiological information obtained by our wearable sensors, while Sunovion incorporated the Embrace2 into the trial design of its antiepileptic drug (AED) APTIOM® (eslicarbazepine acetate) [6].

More recently, we have also partnered with BARDA, a division of The U.S. Department of Health and Human Services, to validate and release our proprietary COVID-19 early detection algorithm using our wearable technology.

If you are interested in joining the growing numbers of clinicians and researchers adopting Empatica’s technology, contact our team here or send any questions directly to research@empatica.com. You can also visit Empatica.com/research to learn more.

Sources

  1. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31787-6/fulltext
  2. https://www.empatica.com/blog/fda-recommended-conduct-of-clinical-trials-during-the-covid-19-pandemic.html
  3. https://www.fda.gov/media/141597/download
  4. https://www.dimesociety.org/index.php/knowledge-center/library-of-digital-endpoints
  5. https://www.nec.com/en/press/201804/global_20180406_02.html
  6. https://news.sunovion.com/press-release/sunovion-submits-supplemental-new-drug-application-fda-use-aptiom-eslicarbazepine/

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Embrace is currently available only in English. Embrace is an investigational device in the USA and a medical device in the EU. If you do not see your country listed, please visit the International site.
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