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Of the technologies now widely used in clinical trials, electronic clinical outcomes assessments (eCOA) solutions are the most common electronic tools. They allow study participants to complete their diaries and patient-reported outcomes (PROs) electronically via devices that are generally provisioned for the whole study duration.

However, even though a provisioned device is the most frequently used eCOA data collection mode, it is associated with challenges such as being burdensome for study sites in terms of logistics, inconvenient for study participants who may already carry a separate handheld device for personal use, and costly for sponsors. Leveraging a study participant’s own mobile device for ePRO and eDiary data collection has become an attractive option—and the "bring your own device" (BYOD) approach, in which participants use their own smartphone to complete eDiaries and ePROs—addresses many of these concerns.

BYOD technology has existed for several years, yet only a limited number of clinical trials include a BYOD option, and examples in which efficacy and safety label claims were based on BYOD PRO data are often not made public.¹ Even when clinical trials include a BYOD option, clinical sites do not always offer it to their study participants and may rather default to the provisioned device.

It is recommended that BYOD solutions be deployed in a hybrid mode, therefore, such solutions include a number of provisioned devices to ensure that participants who do not wish to use their own device or do not have a suitable device are still able to take part in the clinical study.^2-4

What are the reasons for the slow implementation and adoption of BYOD solutions? This article will explore the current barriers to greater adoption of BYOD solutions and includes some information to help clinical trials sponsors opt for BYOD technology when it is appropriate.

What are the barriers to clinical trial sponsors opting for a BYOD solution?

Opting for a new practice always takes time and there are several barriers to a widespread move toward BYOD solutions, whether misconceptions or real obstacles.

Uncertainty whether study participants want a BYOD solution

This is true, not all patients or caregivers will prefer to use their own smartphone over a provisioned device to complete their questionnaires. But some will and some won’t, so it’s important that flexibility remains key. Opting for a hybrid approach allows patients who prefer to use their own smartphone to do so, while those who do not want to use their own device will benefit from a provisioned smartphone.

An increasing number of patients report looking for more simplicity and less burden related to a clinical trial, and a BYOD option is one of the ways to meet this need. In a survey of 1,133 participants, the option of using their own device was selected as “the key feature that the perfect eCOA solution should have.”⁵

Another study demonstrated the appetite of participants for such technologies: 94% stated that they would “definitely” or “probably” be willing to download an app onto their own mobile device for a forthcoming clinical trial.⁶ Based on this growing evidence of patients’ evolving needs and preferences, and because study set-up time is not increased by the implementation of a BYOD/provisioned smartphone hybrid mode, there seems to be no reason not to offer such a choice to study participants when the study design allows.

Study protocol is not always adapted to implement a BYOD strategy

This is also true, there are circumstances in which opting for a BYOD strategy will make more sense than others. Both BYOD and provisioned devices generally work for most trials, but a BYOD strategy should not be implemented for the sake of it: such a strategy, even in a hybrid mode, should only be used when it makes sense to do so.

Several parameters must be taken into consideration, such as the patient population, the type of endpoints, the volume of data that will be collected, the frequency of the ePRO and eDiary assessments, and the study timelines. Exploring the various options with a team of eCOA specialists when planning clinical programs is the right thing to do, and cautiously assessing whether a BYOD option would be suitable for a given trial is necessary.

Fear that the solution will not work on every participant’s smartphone

Even though there might be cases in which a study participant has no smartphone or only has an old smartphone that may not support the BYOD App, BYOD solutions are generally suitable for most smartphones, whether iOS or Android. Solutions are also validated so that they are responsive to variable screen sizes and resolutions. However, in the rare situation in which a study participant’s smartphone is not compatible with the solution, they would not be able to download the app.

In such situations, the site staff will be able to provide a provisioned device. Also, it is the responsibility of eCOA providers to develop systems that ensure the equivalence of questionnaire displays across systems, as well as with reference paper versions.

The updated good practices established by the ISPOR task force⁷ and the recently published Best Practices for Paper to Electronic Migration of Patient-Reported Outcome Measures² provide guidance and create the framework for equivalence across ranges of devices, whether provisioned or not. There is a growing body of evidence that places BYOD solutions as a solid alternative for ePRO data collection and supports the idea that BYOD may be employed to collect PRO data in demographically diverse populations.^1,8

Fear of regulatory scrutiny

The reality is that yes, regulators will scrutinize ePRO and eDiary data, perhaps even more so when these data have been collected for the primary endpoint of a clinical research. The FDA and the C-Path eCOA and PRO Consortia are working together closely through a new forum recently described,⁹ which allows eCOA experts to collectively reflect on their best practices and align them with the FDA’s perspective. It is important to note that the FDA does not consider BYOD solutions to be problematic, and even recommends exploring this option due to the increased flexibility for patients and as it fits with their current effort to expand diversity in clinical trials.^9,10

That being said, the FDA does express the concern that patients should not be excluded from a clinical trial because they do not own a suitable phone, and realistically, it is expected that some level of provisioning of devices in eCOA studies will remain for the foreseeable future. Hybrid strategies are currently, and will remain, best practice both to support patients without a suitable device and when patients simply do not want to use their own device.^4,10,11

Despite the advantages of BYOD solutions that are available for clinical trials, clinical sites do not always easily opt for this as a standard approach.

What are the barriers to clinical trial sites adopting a selected BYOD solution?

Similar to the industry’s hesitancy in moving towards selecting BYOD solutions in clinical trials, adoption by clinical site staff also remains slow.

Fear that it will be more complex

This fear comes from a legitimate but perhaps misinterpreted concern regarding how a BYOD solution will work. BYOD can be very simple, and even more simple than a provisioned device option that generates a greater logistics burden. By offering patients the option to use their own phone, clinical sites not only offer flexibility to their study patients but will also no longer be required to manage the logistical burden of receiving, storing, charging, and dispensing devices, which have been reported by clinical site staff in a recent survey led by the Critical Path Institute to increase their burden.¹²

A BYOD solution also avoids the requirement for site staff to manage device returns or replacements, and they will discover that activating the BYOD solution on a patient’s own device can happen in two clicks.

Fear that their patients will need to be more tech savvy

This might be a misconception. First, patients will continue to have the choice. Should patients or caregivers prefer not to use their own phone, they can easily be provided a device as an alternative option. Second, patients or caregivers who wish to use their own smartphone, feeling that this provides a better and more convenient experience for them, will only need to download an app that is generally available on standard stores, and will easily be able to set up their phone for use in the study.

The eCOA provider can make available to the participants a QR code or a barcode, which can be scanned using the camera on their device to access the application directly. These activation codes often have a limited time validity to avoid malicious use.

Scanning a QR or barcode has become a user-friendly practice, therefore, the use of BYOD solutions does not require technical expertise from either study participants or study site staff. And should a patient break or lose their own phone, or simply change their mind, they can revert to using a provisioned device at any time, which remains an option throughout the study.

Fear for data privacy and security

This comes as a recurrent and legitimate reason for sites preferring to opt for a provisioned device. Sites may anticipate that the controlled environment of the provisioned device will guarantee a level of security that a personal phone will not. But generally, eCOA vendor applications adhere to HIPAA and GDPR data protection regulations and include encryption that safeguards all data transfers.

The rules to follow regarding the protection of data confidentiality are highlighted by the EMA in the recent guideline on computerized systems and electronic data in clinical trials.¹³ Additionally, considering using an online solution that does not store data on the patient’s phone is a way to mitigate this risk. This allows data to be automatically transferred rather than being stored on the patient’s phone, which significantly reduces data privacy and security risks.

Fear that help desk services will not be equivalent to the ones in place for provisioned devices

Site staff should not fear that they will have to act as a help desk service for patients. eCOA vendors are required to provide help desk services that function in the same way for provisioned devices. The level of support is the same, help desk teams are trained on accessing and using the app and can resolve most of the issues.

When a query cannot be resolved, escalation to the next level of support is activated in the usual way. It is also of note that easily accessible back-up solutions are generally planned, such as web-accessible eCOA solutions or quick access to a spare provisioned device for the study participant to use if they lose or break their own smartphone.

Having increasingly demonstrated comparability of data versus provisioned devices and now being considered as providing significant advantages to study participants, the volume of clinical trials that include a BYOD option is expected to rise significantly in the coming years. As eCOA technology, study participant preferences, and best practices evolve, the barriers to implementation and adoption of BYOD solutions by sponsors and sites will continue to be tackled in parallel to regulatory bodies accepting more and more data collected in this way, and it seems that the promise of BYOD opens a new chapter in eCOA data collection.

About the Author

Estelle Haenel, PharmD PhD, Chief Medical Officer at Kayentis.

References

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