The Role of Patient Choice and Control
How BYOD creates patient-centric success in clinical trials
Kelly Dumais, Ph.D. – Director, eCOA Science and Consulting at Clario
The use of Bring-your-own-device (BYOD) in clinical trials has evolved with the growth of smart phones. Research shows that trial participants would be willing to use their own device for a clinical trial1, including those over the age of 602. Medicine agencies have acknowledged the use of BYOD in their most recent guidance. The EMA states that “Both ePRO data and clinician reported outcome data may be captured by privately owned devices such as mobile phones, tablets, computers and wearables, i.e., BYOD.”4.
The potential impact of BYOD on compliance has been a concern, however Clario research3 indicates that BYOD compliance remains high when using BYOD, while assessment completion time is comparable. Based on that, adding BYOD to a clinical trial may seem like a foregone conclusion, especially if it saves on device training and shipping cost.
For BYOD to be used successfully in any study however, it should be approached from the patient’s perspective and be seen as a strategy to improve patient participation and compliance, not as a means to reduce operational overhead. The EMA guidance says that “It is necessary to provide alternative ways of data collection e.g., devices provided by the sponsor, as the trial participants should not be excluded from a trial if not capable of or willing to use BYOD”4. Consider the patient population, age and location, and the smartphone penetration in the geographies where the trial is looking to recruit.
A further consideration is to look at the meta data to understand the impact of using BYOD within the trial’s therapeutic area (TA) and indication. Compliance can vary3 depending on the TA, indication and the assessment burden placed on the patient.
Although none of these are actual barriers for implementing BYOD, they are considerations which help to inform how BYOD can be part of the PRO strategy and how to optimize the use of BYOD accordingly, through varying the percentage of provisioned devices e.g., based on smartphone use and trial population.
BYOD offers trial participants a choice and, rather than giving them an additional device, BYOD makes use of participants’ familiarity with their own mobile phone. In addition, clinical trials can at times put impossible standards on patients about what to do and when to do it and complete diaries so frequently and for so long. BYOD gives patients an element of control back and a say in the process.
These are important concerns for participants when deciding whether or not to take part in a study, especially if it includes symptom-based diaries where they may be entering data throughout the day. And once the decision has been made to use BYOD, it helps to make the choice device by the patient part of the study recruitment strategy.
In summary, a successful BYOD strategy should be offered as a patient-centric and data-driven choice. Although any given clinical trial is unlikely to be 100% BYOD, as provisioned devices should be made available to accommodate participants that don’t want to use or have their own phone, a considered BYOD strategy will likely support recruitment efforts and improve participant retention in clinical trials.
Pioneering enhanced accessibility in clinical trials
The quest for making clinical trials more accessible is continuous and crucial. Clario delves into the significance of zoom functionality, revealing its transformative potential to broaden accessibility and enhance the trial experience for participants.
Kelly Dumais, Ph.D.
Director, eCOA Science and Consulting
1 Shahraz et al, 2021, Journal of Patient-Reported Outcomes
2 Byrom et al., ISPOR 20th Annual European Congress, Nov. 2017
3 Clario research
4 EMA, 2023. Guideline on computerized systems and electronic data in clinical trials. Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf