Proceedings: DIA 2018 Global Annual Meeting

Considering Use of Bring Your Own Device (BYOD) in Clinical Trials

Sarrit Kovacs
Clinical Outcome Assessments (COA) Staff, Office of New Drugs (OND), CDER, FDA

Wen-Hung Chen


he panel of stakeholders convened for “Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?” presented current regulatory views and new evidence on the use of Bring Your Own Device (BYOD) approaches to collect electronic clinical outcome assessment (eCOA) data in clinical trials, and identified unmet areas of future research.

Key Takeaways

  • BYOD is an area of active research and consideration by various stakeholders.
  • Regulatory requirements for electronic data capture (e.g., US Code of Federal Regulations Title 21 Part 11) apply to eCOA data collection regardless of the method used to record data.
  • It remains unclear whether one approach – BYOD or provisioned device (PD) from the clinical trial site – is consistently advantageous over the other.
  • Further work to address the considerations of a BYOD approach in clinical trials is necessary.

Comparability of Participants’ Preference and BYOD versus PD Compliance

Researchers agree that not all participants would prefer a BYOD option over a PD option in a clinical trial. This is contrary to the claim that participants may be reluctant to carry two devices; carrying a PD may depend on the eCOA data type, (e.g., collecting event-driven data).

Additionally, researchers found that compliance was comparably high in both BYOD and PD groups, and they also shared similar compliance issues and need for compliance monitoring. One concern with a BYOD approach is that participants can change/turn off their notification settings, which may lead to missing data. However, sponsors can ensure that sites track compliance and telephone BYOD/PD participants who appear to be non-compliant to minimize the extent of missing data.

In fact, permitting only BYOD in a clinical trial for eCOA data collection would likely be problematic because some participants’ may be reluctant to use BYOD (e.g., privacy/security concerns, using their own cellular company/data plan for data transmissions). PDs should be available as an alternative option to avoid selection bias and ensure generalizability of clinical trial findings to the broader patient population. In addition, if the BYOD malfunctions or is lost or stolen, there is a need for the participant to obtain a PD from the site and become trained on this new provisioned device as soon as possible during the trial. Finally, sponsors must ensure that participants can receive technical support for BYOD.

Carry PD or Leave it at Home? Depends on Your eCOA Data Needs

It is a testable hypothesis that participants may find BYOD preferable over PD to avoid having to carry two devices all day long when completing event-driven diaries (i.e., event log) such as a bowel movement daily diary to capture chronic diarrhea events, or a urination daily diary to capture overactive bladder events. In contrast, when eCOA data are being collected using an end-of-day 24-hour recall diary or weekly diary, PD participants could leave their PD at home during the day, and complete their diary at home at the end of the day.

Minimizing Avoidable Measurement Errors and Missing Data; Optimizing Data Integrity

A PD approach appears to be preferable over a BYOD approach in terms of:

  • Using the sponsor’s cellular signal/company across all clinical trial participants
  • Using a standardized and consistent platform for data collection, reducing unwanted variability in the clinical trial data
  • Sponsor can implement restrictions on use
  • Sponsor can quickly replace the device, preventing loss of data and data integrity.

BYOD risks include unexpected or unavoidable software updates, ensuring sufficient capacity exists on the BYOD to safely store the eCOA app data until it can be transferred to the study database, and loss or theft of the device.

Session Chair: Bill Byrom, CRF Health

Panelists: Sarrit Kovacs, CDER, FDA; Bryan McDowell, Novartis Pharma AG; Willie Muehlhausen, ICON Clinical Research

Considerations for Future Studies

  • Longitudinal, parallel BYOD/PD groups study with use of an event log to allow comparison of participant burden, compliance, device/app issues, management of device interruptions, missing data, data integrity, etc.
  • Evaluation of participants’ preferences/feasibility of BYOD/PD/web-based approaches to collecting end-of-day or weekly diary data (Wi-Fi availability versus cellular data internet access)
  • Pooling usability and equivalence testing data across multiple devices/operating systems/platforms and comparing data for analysis
  • Collecting demographic characteristics and detailed reasons for participant refusal to use BYOD versus PD.


BYOD is an area of active research and consideration by various organizations and stakeholders. It is currently unclear whether one approach – BYOD or PD – is consistently advantageous over the other; each approach presents advantages and disadvantages depending on their context of use. Future work is recommended to address implementing the BYOD approach in clinical trials, to help inform future research and drug development programs.

This report reflects the views of the authors and should not be construed to represent FDA’s views or policies.