Traditionally, electronic Clinical Outcome Assessments (eCOA) data has been captured via provisioned devices, i.e., devices that have been provided to participants. The main reasons for this are to ensure that the patient-reported outcome instruments are displayed identically for all patients, and the desire not to exclude participation due to hardware ownership. However, over recent years there has been a noticeable rise in the number of sponsors and CROs looking to design their clinical trials around a Bring-Your-Own-Device (BYOD) strategy. This has ultimately been driven by the widespread availability of the technology that increasingly spans populations of different ages, geographic locations and economic backgrounds. BYOD allows participants in a clinical trial to provide study data using their own internet-enabled hardware. Not just restricted to smartphones, this could also be a tablet, desktop computer or laptop. The shift towards BYOD promises a transformation of how field-based Electronic Patient-Reported Outcome (ePRO) assessments are implemented in clinical trials, and while the approach has traditionally been used in late-phase studies or short studies collecting objective data not supporting a label claim, application has turned to its use in Phase II and III trials. Here, Bill Byrom from CRF Health, discusses the pros and cons of the approach with readers, and shares valuable insights for those considering adopting a BYOD approach within their studies.
There is a drive towards greater patientcentricity in today’s clinical trials.
Simplifying trial participation is a key element of this. Enabling patients to use their own mobile devices or computer hardware to provide patient-reported outcome data may make trial participation more convenient and reduce training requirements. In a BYOD study, patients do not need to use, carry and keep charged a second handset while participating on the trial.
When it comes to reducing the time and cost associated with the traditional method of supplying patients with a dedicated handheld device, a BYOD strategy is perceived to contribute significant advantages. By eliminating the need to source, provision and supply devices to the entire patient population, sponsors may be able to realise cost savings, particularly in large studies. Eliminating the need to store devices, as well as manage deliveries and returns may also reduce the burden on study sites.
BYOD offers numerous benefits to patients — as previously mentioned, allowing them to use their own device provides optimal familiarity and reduces the perceived burden of having to carry around an additional device for the duration of the study. We have already seen that patients, when choosing a mobile device for personal use, self-select a device that has good usability for their individual needs. For example, we observe that the proportion of patients using larger screen (tablet) devices is higher amongst elderly cohorts compared with other adult age groups. We believe this factor will improve usability and reduce training requirements when a patient collects ePRO data using their own mobile device. Having the ePRO solution on the device they routinely use throughout the day for other purposes may also mean that the trial can easily fit into their everyday schedule, improving the accessibility and usability, and making it simpler for them to meet the obligations of the trial. Coupled together, these factors may improve the patient’s overall experience and, in turn, boost compliance and improve the quality of data captured.
Although there is no official guidance from the regulatory bodies around BYOD trials, and we’re not aware of any new drug applications containing BYOD data yet, they have informally indicated they are open to the concept and recognise the benefits it might bring to patients in a clinical trial.
As with any approach to collection of patient-reported outcome data, there are a number of essential elements to consider. First, will the display of validated instruments on screens of different sizes ensure that the instrument’s measurement properties are unchanged when compared to the format it was originally developed in. While this may seem more complex to demonstrate in a BYOD setting, where the devices that patients will present with are unknown, there is a growing body of evidence supporting migration equivalence when instruments are implemented electronically on screen-based formats. Along with industry colleagues, I recently published the industry’s first formal equivalence study exploring the measurement equivalence of patient-reported outcome data collected using BYOD compared to paper and a provisioned device. 1 This study, published in Value in Health, provides reassuring results supporting the validity of instrument measurement properties using BYOD.
A second consideration is mitigating the possible loss of data due to data plan restrictions, patients upgrading to new devices mid-study, turning off in-app diary reminders, or not having a suitable device to use. With all BYOD studies, we recommend allowing for a quantity of provisioned handsets to ensure that patients without a suitable device (or unwilling to use their own device), and those changing to a device that is unsuitable, can be provided with the means of collecting or continuing to collect their self-report data throughout the study. In addition, we also recommend that patients leverage Wi-Fi connections when available to limit data plan restrictions affecting data transmission. While the quantity of data transmitted using eCOA is typically very small, local storage of non-transmitted data is also important to ensure that data will be transmitted when a connection is made, or when a data plan renews for the following month. In our experience of running the industry’s largest phase III BYOD study, we observe that ePRO completion rates are at least as high amongst patients using their own handsets compared to those receiving provisioned phones. This suggests that missing data is no greater in BYOD settings than when providing provisioned devices.
A third consideration is related to limitations in data security when operating with mobile devices owned by the patients themselves, where the vendor has less direct control. It is a myth that a well-designed app cannot enjoy the same level of data security when downloaded onto a patient’s smartphone compared to the solution provided on a provisioned handset.
Finally, careful consideration of site and patient acceptance of the use of BYOD is a critical success factor for any study where BYOD is being considered.
While global smartphone ownership is increasing — current figures suggesting that over a third of the adult global population own or have access to a smartphone 2— not all trial participants will have a smartphone, and not all may be willing to use their own device for the purposes of the trial. It is essential not to eliminate trial participation based on smartphone ownership. Study samples should be representative of the underlying patient population, and sample bias due may be introduced if samples are limited based on technology ownership.
To counteract this issue, sponsors should consider implementing a “partial provisioning” strategy, where patients who own smartphones enter their data using the app or browser on their own device, and those who don’t have a suitable device (or are unwilling to use their own) are provided with a dedicated device to do so. Typically, these provisioned handheld devices are mobile phones which have had their texting, calling, and browsing functionality disabled and have been programmed to run only the dedicated eCOA software.
To improve BYOD uptake, solution providers should ensure that the app utilised within their study is designed to work across the most widely used operating systems (Android, iOS etc) or web browsers (Internet Explorer, Chrome, etc).
Absolutely. There is a misplaced belief that the provisioned devices traditionally used with an eCOA approach are inherently more secure than a clinical app on a personal device. In fact, it is practical to build all necessary security and protection controls into the trial software, whether it is delivered through a personal or provisioned device. This will include password / PIN protection, session timeouts, data encryption during local storage and transmission, ensuring data is segregated from access by other apps, and ensuring the app cannot access other personal data on the smartphone.
With growing public concern for cyber security, it is also likely that some patients will be uncomfortable sharing health data via an app, so it is important that researchers are able to provide clear information to reassure participants that the software is secure and is only being used for the purpose of the collection of self-report data during the study. By providing training and a clearly-worded informed consent process, researchers can alleviate patient concerns and improve BYOD uptake.
When considering a BYOD approach, it’s important to also decide whether to collect data through an app downloaded onto the patient’s smartphone or tablet, or to collect data through a web browser using a mobile device or PC/laptop computer.
Web provides easy access from multiple devices and may be superior for very long studies where technology and app-compatibility may change over time. It may also be preferable for studies requiring only infrequent completion (for example, quarterly completion as part of a long-term registry) where users may be less willing to retain a locally installed app that is only used occasionally. A disadvantage of web is the requirement for connectivity to complete the COA instrument(s) and so it may be less suitable for certain types of eCOA application or for use in certain geographies.
Using an app provides the ability to enter data and complete COA instruments without a mobile connection. This may be important in studies requiring frequent completion, or studies in locations where connectivity may be limited. A disadvantage of app is the need to download and to ensure its compatibility on patient devices for the duration of the study.
At CRF Health we have significant experience in delivering large BYOD studies using both app and web, and our operations and scientific experts can provide advice to clients in selecting the optimal approach for individual studies. We can also support Sponsor discussions with regulatory bodies where required.
BYOD has been somewhat of a hot topic in the industry for a few years now, with adoption continuing to grow. Despite many in the sector being hesitant to make their move due to scientific, technical, practical and regulatory concerns, the majority of these issues can be mitigated in studies where BYOD provides an appropriate option. We expect to see the use of BYOD continue to increase as we strive to make trial participation and the collection of robust clinical outcome data more convenient. In addition, we expect to see new drug applications containing patient-reported outcome data collected using BYOD to be submitted to regulatory bodies in the coming months, and this will provide a clear indication of the acceptability of submission data collected in this way. Despite this, we see that all BYOD studies will be supported by a partial provisioning strategy to overcome the unavailability of device ownership by all potential study participants.
While we see BYOD increasing, we believe that decisions between BYOD and full provisioning will be made on a studyby-study basis, taking into account study designs, patient populations, geographies and patient and site acceptance – and we expect to see both approaches being used for the foreseeable future.
1. Byrom B, Doll H, Muehlhausen W et al. Measurement Equivalence of Patient-Reported Outcome Measure Response Scale Types Collected Using Bring Your Own Device Compared to Paper and a Provisioned Device: Results of a Randomized Equivalence Trial. Value in Health 21: 581-589, 2018.