THE BASICS OF BYOD: eCOA AND THE PATIENT’S PHONE

 

Ken Faulkner and Katarina Korsback explore the potential benefits and pitfalls of Bring Your Own Device (BYOD) in eCOA clinical trials, as well as the current regulatory perspective. In this episode we discuss the future hold of BYOD, the value of patients using their own devices and the technology needed for BYOD trials.

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Introduction [00:45]

Ken Faulkner and Katarina Korsback explore the potential benefits and pitfalls of Bring Your Own Device (BYOD) in eCOA clinical trials, as well as the current regulatory perspective. In this episode we discuss the future hold of BYOD, the value of patients using their own devices and the technology needed for BYOD trials.

What does “BYOD” mean in the context of a clinical trial? [03:33]

In BYOD, or bring your own device, the patient uses their own cell phone to complete their reports. This simplifies the process for patients, who are already very familiar with using their cell phones to complete a number of tasks, and makes it easier for them to remember to participate. BYOD has not yet extended to devices other than cell phones.

What are the benefits of a BYOD trial and the effect it has on eCOA reporting? [05:05]

There are two main benefits of BYOD: familiarity and simplicity. Because patients are already familiar with the device and carry it around constantly, it’s much easier to encourage them to be compliant. BYOD is typically app-based, something most patients will know how to navigate.

What are some of the potential pitfalls of BYOD? [06:22]

It’s important to note that there are many factors that need to be considered in order to successfully implement BYOD, including complexity, frequency of recordings, data volume, and patient location. These factors, and others, can have a large impact on a study’s budget. Additionally, sponsors should have a back-up phone provision plan in case patients don’t want to use their own devices.

Has the volume of phone options available been a pitfall in implementing BYOD? [09:24]

Although there are a number of devices available on the market, most patients generally have one of a few different types of phones and/or software. This has made implementing BYOD a simpler process. However, the app’s compatibility with a number of systems should be assessed before moving ahead with BYOD in a study.

What’s the currently regulatory perspective on BYOD? [10:21]

Because BYOD is a fairly new concept, regulatory bodies have not yet formed a final opinion on its use in clinical trials. However, regardless of what device is used or how data is collected, a trial that uses BYOD must also adhere to all existing regulations, just like any other trial. Experts anticipate that there may be more regulatory oversight on BYOD in studies where PROs are a primary efficacy endpoint.

What impact will BYOD have on the industry and eCOA reporting?  [11:29]

BYOD is not a shortcut, but rather a simpler approach to collecting data in a trial. Sponsors and study teams will still need to follow their typical set-up and training processes. Industry-wide discussions will need to take place, however, in order to address BYOD’s impact.

What’s the future of BYOD and eCOA? [12:54]

BYOD is here to stay, but it should only be implemented in a trial after the cost and benefit aspects have been evaluated. Sponsors need to ensure that they’re choosing the right trials in order to use BYOD effectively. Advances in technology may also make BYOD more effective in the future. An ongoing dialogue with regulatory bodies as these changes unfold will be necessary.


TRANSCRIPT:

 

[Intro]: Welcome to the Trial Better Podcast. In this episode we discuss Bringing Your Own Device, also known as BYOD. BYOD is one of the newest trends in clinical trial management, allowing patients to self-report data using devices they already own. Our host Ken Faulkner and featured guest Katarina Korsback review the pros and cons of BYOD, examine its uses and review the process of conducting a BYOD study. Stay tuned to learn more on Trial Better.

Ken Faulkner: Welcome to our Trial Better Podcast. My name is Ken Faulkner, I’m Vice President of Scientific Services at ERT. More and more we’re being asked to include measures of how a patient functions and feels using a variety of assessment techniques. And as technological advances are made throughout industry, regulators like the FDA and pharmaceutical sponsors are looking for ways to leverage technology to collect field-based patient data, and much of this interest is centered on the use of smartphones. 

Traditionally study participants were provided smartphones or tablets to report their data. But recently many clinical trials are utilizing “bring your own device” or BYOD approach, leveraging patient’s own internet enabled mobile devices to collect data instead of providing each patient with the provision device. This gives us a lot more flexibility, but there are also some challenges and today we’d like to explore the pros, sorry for the pun, and cons of a BYOD model, examine the potential challenges and get a glimpse into the future of BYOD options for collecting patient reported outcome data.

For this conversation, I’m pleased to be joined by Katarina Korsback, who currently serves as the Associate Clinical Program Director at AstraZeneca. She has extensive experience in the biomedical and research industries, and over the last two decades has been focused on pharmaceuticals and has had many roles in different therapeutic areas and has been responsible for patient reported outcomes or PROs in a myriad of clinical trials. Previously, she worked in intercultural and global organizations such as the WHO, UNICEF and the World Bank in Europe, the Middle East, Asia and Africa. Katarina’s academic background is of the Natural Sciences and Clinical Nutrition where she earned a master’s degree in Biochemistry and a Master of Public Health in Nutrition. So, thank you for joining us Katarina and welcome to the Trial Better Podcast.

Katarina Korsback: Thank you very much.

Ken Faulkner: So, would you mind just maybe starting us off, give us some background on your experience with electronic patient reported outcomes assessments?

Katarina Korsback: Yes, I have worked in the clinical team here in Astra Zeneca, and I have worked quite a lot. I mean we have included the PROs in almost in, a lot of studies in different therapeutical areas since many years. So, I have had lots of different devices in the trials, ERT devices, AM three, long pads, tablets, et cetera. And we have also one study that we have included in this bring your own device solution, with a patient’s own cell phones. So, it’s only one study so far with this option.

Ken Faulkner: No, it’s fascinating, it sounds like you’ve had quite a bit of experience in what it seems like it’s a young field, but you’ve been doing this for a long time. For you, what does BYOD mean? What does that mean to you in terms of conducting a clinical trial?

Katarina Korsback: Yes, I mean, Bring Your Own Device, obviously the patient is using their own cell phone, which they are very used to have. I mean, nowadays we all carry around our own phones all the time, so it’s very simple for them and they don’t, they keep aware of it and they don’t forget it. I mean, the risk of forgetting, it’s much less than if you have to carry an extra device.

Ken Faulkner: Oh, fascinating.

Katarina Korsback: Yes, the simplicity I think is a good advantage.

Ken Faulkner: Well, is it just smart phones? Are there other devices that you’ve, candidate BYOD devices that you’ve considered?

Katarina Korsback: No, in this first study, it’s the cell phones we use.

Ken Faulkner: Yes. I always wonder, there’s a lot of things like Fitbit’s out there and activity monitors and all kinds of things that people could potentially, and they want to try and use. So, you’d haven’t run into that yet?

Katarina Korsback: Well we have had; in previous studies we have had actigraph and other devices or activity logging a patient’s activity or physical activity and other devices. But I haven’t really thought of the bring your own device as extended to more than cell phones actually.

Ken Faulkner: Yes, well I think that’s probably true for most of us too. I think it’s been a challenge enough just to get people to use their own smartphones. So, Katarina, tell me what are some of the benefits of having bring your own device trial?

Katarina Korsback: Yes, I think the overall benefit, as I mentioned I think is simplicity. Patients don’t need to remember to carry around an extra device. They are very familiar with the phone and I mean they keep track on it all the time as we all do. And the technologies are AC, they or they download the app and it’s something they do all the time. So yes, they are very familiar with the device per se and with the technology as well, I think.

Ken Faulkner: Yes, well absolutely. And I guess not having to provide the phones is a benefit too to the company.

Katarina Korsback: It is. Although we usually have Plan B, so we also have the option of permission devices too. And it may be when we introduce these in trials, it could also be of course that patients don’t want to use their own phones. We haven’t had that experience so far, but it could be. So, we always include an option of provision devices, provision cell phones as well.

Ken Faulkner: So yeah, it kind of leads me to the other side of the question. What are some of the problems that you have encountered or pitfalls of using your own device, so BYOD?

Katarina Korsback: Yes, of course there are pitfalls too as always in any solution or option. Some are probably only I would say childhood diseases and can be overcome, when we together with the vendor like ERT and the industry and the patients can feed back on our experiences like we do now for example. But there are of course other more general things that you always need to consider when you select the best option for your study. And I think aspects like complexity, frequency of recordings in the device, like study receipts and number of questionnaires of course, and also number of patients in this study. I mean the volume of data and off the list which countries you go in, what regions of the world, and that also leads into the budget of course. I think the bring your own device solution that you’re using a patient’s own cell phones, it can be cost effective if you go in countries where the majority of the patients have modern cellphones, and then in countries where they are already used to installing the apps and all that.

If you’re not in those countries, there may be that you choose another option anyway. And of course, the cell phones, not only they must be a modern kind of course, but also have sufficient memory. That is something that we have experienced in this first study because obviously the app takes, it requires quite substantial amount of memory in the phone, depending on number of questionnaires, et cetera. So that’s important to consider I think; we had for example, in this study, the patient that had to be rescheduled because they couldn’t install the app. This particular patient had a lot of photos and things like that. So, she had to go home, and you know, take care of the photos and then come back with more memory on the phone.

There are different aspects, and then of course, as I said, I mean we usually have the option of the provisioned phones and then you come to the point where you say, is it cost effective? If we anyway need to provision a lot of phones, then of course we haven’t gained anything budget wise. So, I think yes, we need to, I can’t say they assess the study, which countries, how many, if we are approaching the budgetary limits or not. So, in, but in the countries and in studies where we expect that most patients will have their own phone. And then of course it’s definitely, it’s a solution to consider for sure.

Ken Faulkner: Well, it’s fascinating. I was just thinking about how I think my smartphone as a close friend. I like my kind of phone. But across the world everybody has their own preferences. There’s a lot of different models and brands and configurations. Has that been an issue?

Katarina Korsback: Well it hasn’t so far but even if we are only now limiting, we are limited in our experience to Sweden, Denmark, UK, most people have more or less same brands. And of course, your option in ERT, the app can be installed in different phones. But we still have had some problems with installing the app. So even though we are in rather homogeneous countries it must be assessed beforehand.

Ken Faulkner: Yes.

Katarina Korsback: When we, yes before we select which option to use.

Ken Faulkner: So how does the regulatory agencies feel about BYOD trials?

Katarina Korsback: Well, I don’t know if there is any concerted view. We assessed, as I said we have only tested this now in one study in our company and I don’t have the overview of the industry per se. So, I really don’t know the prevalence, so to speak in the industry. But regarding, for example, the aspects of that person privacy or data privacy, I don’t think that would be really a concern by the authorities because we of course adhere to the requirements, those regulations regardless device, so that’s fine. But scientifically there might be more concerns if you have the study or studies where the PROs are primary objective, and I mean primary efficacy objective or endpoint. Then I’m not sure what they would say, I don’t think there is a concerted view. We don’t have a lot of experience as I said, so I don’t have the overview myself. But it could be discussed, I’m sure.

Ken Faulkner: Yes, I think your, but your experience matches mine too. I think we have a lot of questions and we’re still in the early days of figuring out the right way to do that so.

Katarina Korsback: Exactly. And what we, when we selected which study to pilot this concept, you know, we have selected this study, which is, it’s an observational study where we then only follow the patients to characterize them. So, we have not, chosen a study where we have PROs as primary efficacy endpoint because that is to be discussed much more I think when you compare groups, so that’s second [inaudible 12:09].

Ken Faulkner: Well, I guess so at this point really, is there been any, have there been any approvals that have leveraged BYOD data, pharmaceutical trials that had been approved?

Katarina Korsback: Well, as I said, I don’t have the full overview, but I doubt that. I don’t think so. Since this is a new concept, rather new concept. And as we all know, it takes a long time to get approval for launch. So, I simply don’t think there has been time enough for having that, but I don’t know.

Ken Faulkner: Well, that’s, it’s I think just part of being at the forefront of the fields. I mean, you’re forging new ground and it’s been, it’s exciting to see.

Katarina Korsback: Yes exactly.

Ken Faulkner: Well, what’s the future going to be then for BYOD? What do you think?

Katarina Korsback: Well, I think it’s here to stay, but of course as I mentioned, and I mean you always have to evaluate the cost benefit aspects and select the right studies so to speak. The studies which fits the purpose, so I think it is here, we will use it more and more, but we must then improve the technology together and evaluate which studies we use it in and have a dialogue of course with authorities also.

Ken Faulkner: Well, any final thoughts before we close?

Katarina Korsback: Yes, we haven’t talked about the setup process, the app programming and things like that. Use and acceptance, [inaudible 13:49] and trainings and all that. So, but anyway, that is of course always there regardless of the device. So, you don’t have any short cuts just because you use the patient’s own cell phones. That is of course a component of the planning process also, even if we have simplistic approach with a device per se. So, there we have a lot to discuss or perhaps some other time.

Ken Faulkner: That’s a good, that’s a good point. Yes, I think just the devices, the whole trial conduct still has to happen even if it’s a BYOD study.

Katarina Korsback: Yes, exactly. But those, I think those aspects were what I meant with the childhood diseases. These can be overcome but we definitely have more discussions to have on this topic.

Ken Faulkner: Well it’s exciting to hear what you’re doing and forging new ground, you and your company and the others out there. It’s exciting for me to learn about so, but I wanted to thank you for your time and for taking the opportunity to speak with us a little bit about BYOD.

Katarina Korsback: Oh, you’re welcome.

Ken Faulkner: You’re very pleased about it and thanks to those who have listened in on our Trial Better podcast. Again, I thank Katarina Korsback who has been our guest. My name is Ken Faulkner and we look forward to talking with you next time.

[Outro]: That’s a wrap for this edition of Trial Better. Special thanks to both Katarina and Ken for exploring with us the world of BYOD. I’m sure many of our listeners will look forward to learning more as the technology advances. As always, if you heard something you like or want to know more, please send us a message at trialbetter@ert.com. See you next time on the Trial Better podcast.



FEATURED GUEST:


Katarina Korsback currently serves as Associate Clinical Program Director at AstraZeneca.


She has over 35 of experience in the biomedical and research industries. Over the last two decades focused on pharmaceuticals, Katarina has held many roles in different therapeutic areas and has been responsible for Patient-Reported Outcomes (PROs) in a myriad of clinical trials. Previously, she worked in intercultural and global organizations such as WHO, Unicef and the World Bank in Europe, the Middle East, Asia, and Africa. Katarina’s academic background is within natural sciences and clinical nutrition where she earned a Master’s Degree in biochemistry and a Master of Public Health.

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