Provisioned, BYOD and Hybrid Models for ePRO: Which Is Right for Your Trial?
As more and more trials opt to include electronic patient reported outcomes (ePRO), sponsors must consider whether they will provision devices or use a bring-your-own-device (BYOD) model. In some cases, they may choose a hybrid option that allows some participants to use BYOD and others to receive provisioned devices. In a recent blog post for WCG Insights, Jan Sedway, vice president of clinical science for WCG VeraSci, lays out key factors to consider when deciding on an approach for ePRO.
“It is important to consider participants’ preferences, particularly in trials where recruitment is challenging,” says Sedway. For example, many participants like the convenience that a BYOD model offers, so they do not have to keep track of a separate device to use for the trial. For trials where there may be some stigma attached to participation, completing assessments on their personal device may be more comfortable for participants because they do not have to explain the presence of an additional device, she adds.
On the other hand, some participants may be hesitant to download an app to their own devices. They also may be reluctant to use cellular data for a study and prefer a provisioned device to ensure they are not paying for data they are using for the study. Although this does not appear to be a widespread concern, provisioning a device can alleviate that worry. A hybrid model accounts for each individual participant’s preferences.
Regulatory Compliance and Security
One advantage of provisioned devices, Sedway notes, is that sponsors can have greater control over the device. Sponsors have greater oversight over security measures and assurance that each device configuration is adequately tested. At one time, there was some concern that without these measures, regulators would be hesitant to accept ePRO data collected in a BYOD model. Several of the large COVID-19 vaccine trials used to support authorizations with many major global regulatory agencies utilized BYOD ePRO data. This precedent is providing sponsors with greater confidence in using BYOD.
An additional advantage of BYOD is that devices are more likely to be charged regularly and less likely to be lost or misplaced.
Patient Accessibility and Burden
For some patient populations, requiring participants to have a smartphone that meets the requirements of many ePRO solutions could be a barrier to participation. This is particularly true in older populations, in populations that contain significant numbers of socioeconomically disadvantaged groups, and global trials that have sites in areas with lower rates of smartphone use, she says. A hybrid solution that provides devices to participants upon request can alleviate this burden. Even in populations where this may not be a barrier to recruitment, an option to provide devices can increase the diversity of trial participants.
Tablets and Ease of Use
When most people think of ePRO, they envision diaries and assessments completed on a smartphone. However, assessments that require participants to manipulate objects on a screen, such as the Trail Making Test (an assessment frequently used in neuropsychological testing), may work better on the larger screens on tablets, Sedway explains. When tablets are utilized in a trial, it may be necessary to use either a fully provisioned or hybrid device model. Comparatively fewer people will have a tablet that meets the requirements for most ePRO solutions. Requiring participants to have a tablet would be a significant burden to place on participants and would inevitably create enrollment challenges.
A Focus on Support
When selecting a device model, it is important to consider the impact on technical support needs. Provisioned devices typically arrive at sites completely configured, but sites may need additional training and support to assist patients in the set-up of BYOD devices. Additional training and documentation also may be needed for technical support staff to enable support for a wider range of device types, she notes.
Read more WCG insights here: https://bit.ly/3hEqoAQ.