Virtual Trials, Remote Care, & Cross-Border Collaboration: Ethical & Legal Challenges

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Jennifer Cox, Manager, Research Contracts at Ottawa Hospital Research Institute (OHRI), joined us for a thought-provoking discussion around legal considerations in the Canadian health research sector. Among many other things, we dived into the challenges associated with virtual trials, remote monitoring, digitalized patient info, and cross-border collaborations in the time of COVID-19. 

Here is a sneak peek of our conversation:

Q: How did the concept of decentralized clinical trials, including patient-reported trial data, apps on your phone, wearable technologies, and ambient biometrics, surface? And, in the very traditional, legacy ways that we approve drugs, how open was the system to these relatively radical pivots?

A: It was really interesting. All of these technologies have been trying to get off the ground for a really long time. People who work in the space have been saying for a long time, “This is where the future is. This is where we need to be going.” I think there’s been slow uptake from a hospital/medical care provider perspective for a long time, and when COVID came in, they all went, “Oh wow! Okay, you know, we should try this. This is really important.” We saw this in Canada, Europe, and the United States, that’s who we work with most commonly. Everyone said, “Okay, we really understand the value of this, at least right now.”

We saw a lot of studies that could potentially utilize these technologies, and there are a lot of questions that come up. One of the biggest things that come up for me is consent. Do we have consent to do whatever we’re doing? There are two different types of studies. If we’re starting a new study from scratch, it’s a little bit easier to look at the consent and say “Okay well, we know from day one that this is what’s going to happen. It’s a little bit different if you’re already in a study and now you’re incorporating these new aspects to take their temperature or take their biometrics of whatever method.

We also saw within these studies a couple of types of things that they are measuring. One is, do you have a difference in the quality of care? If you have your baseline standard of people come in and they get this quality of care in the hospital, we have that data already versus this quality of care when you’re doing remote care. We saw those types of studies, and then we also saw these pivots of a study, or something that looked like a previous study, where we’re just providing that care now remotely. You’re not measuring if it’s better or worse care. You’re just measuring, “Does this care work? And what are the outcomes of it?”…

For more of our discussion, you can watch the whole Fireside Chat with Jennifer Cox, or listen to the podcast version, below.

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