Ethical Considerations for Collecting and Analyzing Patient Data with New Technologies

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In this Applied Clinical Trials video interview, Julia Lakeland, Chief Product Officer, uMotif, talks about the ethical considerations that need to be addressed when implementing new technologies for collecting and analyzing patient data in clinical trials, while ensuring patient privacy.

What ethical considerations need to be addressed when developing and implementing new technologies for collecting and analyzing patient data in clinical trials, while ensuring patient privacy, data security, and informed consent?

Oh, there's so much, there is an awful lot to think about. So, within the world of devices and apps today, and I'm kind of talking obviously, wherever boys are sensors, but also mobile devices as well for remote data capture. And, and I've touched on it earlier, you know, looking at the flexibility in the configurability. So that content can be delivered in an individualized manner in a personalized manner to each patient, so that their unique requirements, for example, and language preferences, anything which is culturally specific terminology, all of that can be tailored. And I think there's other ways of communicating, it doesn't just have to be through words, there can be visual diagrams and cues, videos, texts, speech, making sure that you know, the additional information that the participants may want, you know, that that's going to help them within their trial participation. Making that experience more meaningful and more useful to them, and more personal with regards to the feedback in the interactions that the patient has with the device. All of those really start to make sure that the data that we are collecting and therefore will be analyzed within the clinical trial. That then ensures that you're going to have a good compliance and good levels of data being captured. And therefore, you know, literally what the value of the data that you put in matches the value of the data that you get out.

If you have good data going in, you're going to have good data coming out. But I do think that, you know, some of the other ethical considerations that we that we, that we, we want to be considering. And I touched on it very briefly when I said about financial considerations and local infrastructure. But you want to make sure that respondents actually have the have access to the technology. And we have to appreciate that not everybody does. You know, not everybody has the new smartphone. Not everybody has a smartphone, for example. And therefore, what you want to be able to do is make sure that you offer within your study boundary you have bring your own device, which is super friend, and he gets natural high levels of engagement, because it's, it's the device that somebody is familiar with, in comparison, and you need to tailor that to make sure that you have provisioned devices as well. So that if somebody doesn't have or for some reason, they don't choose to use their own their own device. They aren't negatively impacted, and the study is still accessible and available to them.

So again, just making sure that you you're really factoring in both accountabilities they're made, you know, you have flexibility. But you have the personal the personal element, as well. And obviously, that then comes around, you could expand that to be looking at when certain notifications are sent and reminders. So, making sure that your digital health technology is easy to use, making sure that that has been demonstrated, preferably by the patient population that, you know, they have that understanding. And of course, making sure that you know, the data flow is reliable is accurate, its regulatory compliant. All of all of those components certainly come together to ensure that we're instilling trust and accuracy within the data that we're capturing.

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