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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Episode Notes:

 

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.


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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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