Medical Device Clinical Trials 2020

Update on the Implementation of the Medical Device Regulation in Europe

Many processes have been put on hold due to the COVID-19 pandemic, and the upcoming change to the European Medical Device Regulations (EU MDR) is one of them. It’s now been set back a year and is expected to be implemented in May 2021.

In this session, we heard from Bassil Akra, CEO of QUnique Group, who gave us a quick overview of the EU MDR. Here at COUCH Health, you’ll know that we’re really passionate about improving patient engagement and giving patients the best experience when it comes to their healthcare. Akra explained that one of the main reasons the regulations have been updated, is to improve transparency. As a result, the EUDAMED database will have information that the public, regulators and notified bodies will be able to access. And not only will this give different stakeholders a better communication platform, but it’ll let patients see more information about medical devices – such as a summary of the safety and clinical performance – and make more informed decisions before using them.

We’re pleased to hear that not only the pharma industry will benefit from the EU MDR, but there will be positive changes for patients too.

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Reconsidering Trial Design in the Challenging COVID-19 Era

In response to COVID-19, we’ve all had to adjust the way we work and communicate in our daily lives, and the clinical trial industry is no exception. Clinical trials have had rapid adjustments to how they’re structured to make sure they can continue, while keeping patients safe amid the pandemic. And in this session, Paul O’Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata Solutions, shared some examples of how Medidata have been doing just that, with the power of technology:

• eConsent –moving away from the stack of paper, to other forms of information such as video, audio or text that are more easily understood. But most importantly, it provides something patients can access at home, on their own devices, allowing them to digest, discuss and decide remotely.
• Telemedicine – an approach that allows site to continue engagement with patients remotely, such via a phone call or video call for continued engagement

And what’s great, is that regulators have seen the potential for these approaches too – with positive responses from regulators across the US, UK and EU regarding the possibility of technology as an alternative to site visits.

But in particular, one example that stood out to us the most, was the idea of Direct-to-Patient shipping of the clinical trial investigational drug. Medidata explained how the study drug is shipped straight to a patient’s home, instead of the patient travelling to the site to receive it. And it made us think – “why is this not the standard process, or at least an option, anyway?”.  With travel restrictions being a clear barrier to patient recruitment and retention, this seems like an ideal solution.

We hope that while the clinical trial industry has rapidly evolved in response to COVID-19, that this embrace of technology can continue in the future, for a better patient experience.

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Exploring the Use of New Technologies in Patient Centricity

Everett Crossland, Senior Vice President of Commercial at AppliedVR, gave an overview of three technologies and how they can improve patient centricity in clinical trials.

• Using geolocation-based tracking for adverse event detection If you haven’t heard of this, it’sa phone-based technology that plugs into any app, to gather data in an efficient, non-obtrusive way. And, the data is gathered in real time, which means adverse events can be detected quickly and the design of a trial can be adjusted or stopped in good time. It’s also helpful for trials that are years long, as it allows patient engagements to be monitored for long periods without requiring surveys, phone call follow-ups or burdensome data recording, while still gaining valuable results for the trial.
  Example: https://www.positionhealth.co/
• Partnering with employee wellness apps Wellness apps are designed to collect extraordinary amounts of data. And partnering with these wellness apps can provide an opportunity to find and recruit the right participants. Often, wellness apps are focused around mental wellbeing – so this could prove particularly useful for mental health clinical trials. Plus, by partnering with wellness apps, not only can data be gathered, but the apps can be customised for the patient to improve retention and their overall experience.

Example: http://www.sunset.health/

• Adopting virtual reality as a tool for participant retention Amazingly, virtual reality (VR) has been shown to reduce pain, anxiety and stress. So not only does VR offer an opportunity to capture data, leveraging this technology can also improve comfort for patients during a clinical trial, either at the trial site, or in their own home.
  Example: https://appliedvr.io/

It’s technology like this that constantly reminds us how exploring new ways to communicate and leveraging virtual platforms can help us to better engage with patients throughout clinical trials, improving recruitment, retention and the overall patient experience.

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How to conduct a successful post-market follow up survey

We heard from Jón I. Bergsteinsson, VP of Global Business Development at SMART-TRIAL, who highlighted that a lot of manufacturers and sponsors are turning to surveys as a potential, cost-effective way to gather data in a post-market setting to comply with MDR. He shared 4 aspects that characterise a successful survey:

• Relevant and usable data: generic data with no goal or intention will not work. Define a clear goal, endpoints and an analysis to understand what you’re trying to convey with the results.
• Appropriate sample size: ensure the sample size is calculated by looking at what you’re going to test.
• Ease of data entry: ensure the platform is efficient, including the way that the platform is implemented, the different ways to approach data collection, and how motivated your participants will be to provide the data you want to collect. Ad-hoc surveys are way to provide ease of use and traceability of data.
• Compliance: be sure to comply with the applicable standards or regulations that are relevant for your survey in the post-market setting, and remember there may be different regulations depending on the goal of the survey.

Survey based data collection is one way to gather clinical data on performance or safety to comply with MDR, and following these 4 simple steps can ensure a successful survey.

We hope you found these latest industry developments as interesting as we did, and we look forward to seeing more progression in this area going forward.

This blog was originally published here: https://www.couchhealth.co/post/review-medical-device-clinical-trials-2020