BYOD: clinical trials with your own smartphone

Collecting Real World Data using electronic patient reported outcomes (ePROs) has become a standard procedure in clinical research, ePROs are used in 74% of clinical trials today¹. ePROs are reported by patients without interpretation by clinicians and are used to record  relevant events in real time. Not only does this allow clinicians to make prompt interventions, in addition these data are valuable for the evaluation of the safety and efficacy of new medical innovations and provide meaningful insight into the usefulness of the therapy². 

ePROs are collected with an electronic device. Traditionally, trial sponsors provided devices dedicated specifically for this procedure, yet this comes with high costs for the sponsor and burden for the patient, who had to carry around a device exclusively for the purpose of the trial. Therefore, the bring your own device (BYOD) approach is being used increasingly as it addresses these concerns, allowing patients to use their own smartphone, tablet or personal computer to remain engaged with the clinical trial, simply by installing the software or app. 

Trials in which the use of a BYOD approach was compared with provisioned devices showed negligible differences in compliance rates (89% vs 92%)³. Whether the device deployed is a smartphone, tablet or PC does not result in any differences in patient experience or understanding⁴. Over 90% of BYOD participants use a smartphone to participate. BYOD is cost effective, reducing study startup time because no devices need to be delivered to the patient and there is the additional benefit of a reduction in training costs.

However, in order to participate patients actually need to have a smartphone! Although everybody seems to have a smartphone these days, not everyone does! 85% of American adults own a smartphone, yet this number drops to only 61% among people aged over 65⁵. In addition, elderly people have been shown to be less digital literate and people over 60 have been shown to have difficulties in downloading apps (13%), while 19% indicated to not download a study app without any assistance⁶. Yet, at the same time, the majority of new drugs are made for elderly people and thus need to be tested in this subgroup. There is therefore a need for patient focused software that makes a BYOD approach appealing to all age groups. 

Similar trends are seen for socioeconomic status where 75% of people having a high school education own a smartphone compared to 93% of college graduates. Similar rates have been observed when comparing income levels⁵. Today, 80% of the world's population owns a smartphone⁷. Clinical researchers intending to use BYOD can either use possession of a smartphone as an inclusion criteria or provide patients with a provisioned device, which is no longer BYOD. Neither option is ideal as they may induce bias into the study. 

If possession of a smartphone is used as an inclusion criterion, this means that a substantial part of the population may be excluded from trials based with BYOD and as a result the diversity of clinical trials may be limited. This is important as trials should represent people from diverse backgrounds to ensure successful introduction of new medications⁸. At the same time this issue may resolve itself in the years to come as the number of smartphone owners increased by 40% in the last 5 years and is expected to increase from 6.3B today to 7.3B in 2023⁹.

When asked which topics were important to participate in BYOD trials, patients highlighted reimbursement for data charges (74%), ensuring data privacy (78%), ease of installation and use (90%) and no interference with other device functions (97%). Furthermore, 45% of patients would prefer using BYOD, compared to 15% preferring a provisioned device and 40% having no preference⁶. Regulators have approved the use of BYOD as long as it abides to ePRO data collection standards¹⁰. Therefore, BYOD provides a great means to support clinical trials and facilitate the collection of real world data.

A major advantage of BYOD is that it allows the design of interactive interfaces that actively communicate with the patient. Patient engagement has been shown to improve patient compliance and retention rates in clinical trials. At PatchAi we support BYOD and put the patient first through intelligent and empathic software solutions that patients can use on their own device.

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References

  1. Giesinger et al., Value in Health, Past and Current Practice of Patient-Reported Outcome Measurement in Randomized Cancer Clinical Trials: A Systematic Review, 24, 2021. 10.1016/j.jval.2020.11.004
  2. Kyte et al., BMJ Open, Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol, 8, 2018. http://dx.doi.org/10.1136/bmjopen-2018-026080
  3. Khurana et al., Value in Health, State of BYOD: lessons in acceptability and compliance from 35 trials, 155, 2021. https://doi.org/10.1016/j.jval.2021.04.773
  4. Dumais et al, Value in Health, Does the type of device affect usability or conceptual understanding of patient-reported outcomes? Qualitative evidence and implications for bring-your-own-device (BYOD), 173, 2021. https://doi.org/10.1016/j.jval.2021.04.857
  5. Mobile fact sheet, April 2021. https://www.pewresearch.org/internet/fact-sheet/mobile/
  6. Byrom et al., ISPOR 20th Annual European Congress, The influence of age on patient attitudes and acceptability towards using their own mobile device to record patient-reported outcomes data in clinical trials, 2017. https://www.valueinhealthjournal.com/article/S1098-3015(17)32502-0/pdf
  7. Bankmycell. https://www.bankmycell.com/blog/how-many-phones-are-in-the-world
  8. Van Hengel, Why diversity matters in clinical trials, 2021. https://www.patchai.io/en/news/why-diversity-matters-in-clinical-trials
  9. Statista. https://www.statista.com/statistics/330695/number-of-smartphone-users-worldwide/
  10. Proceedings DIA 2018 Global Annual Meeting. https://globalforum.diaglobal.org/issue/august-2018/considering-use-of-bring-your-own-device-byod-in-clinical-trials/