What At Stake For Sponsors Of BYOD Trials: Are Regulators Ready to Accept?
Ever since FDA released its guidance for industry on Electronic Source Data collection in clinical investigations, EDC (Electronic Data Capture) options have given clinical researchers and sponsors new opportunities in running successful clinical trials. In recent years a rise in Electronic Clinical Outcome Assessments (eCOA) solutions have enabled participants to easily submit information while participating in a trial using devices such as tablets, computers, mobile applications and handheld devices enabling quality of data capture and boost compliance to meet regulatory requirements.
Though eCOAs tick all the right boxes, it has not been easy to implement in all kinds of trials due to the sheer expense of maintaining customized devices, logistics of sending them to participants and collection after the trial. With the widespread availability of new technology and data security options, researchers are seeking to design trials around a Bring Your Own Device (BYOD) strategy. BYOD in a nutshell, allows study participants to submit data using personal internet-enabled devices, whether that be a smartphone, tablet, personal computer, laptop, etc. via a web-based or an app-based application. Web-based applications allow patients to connect using any device via a web browser to complete online versions of a particular patient-reported outcomes measure (PROM), whereas app-based BYOD allows trial teams to administer a vast range of PROMs on a patient’s own smartphone or tablet device via a downloaded application.
Why should sponsors select BYOD?
The most important benefit of choosing BYOD for a trial is its promise of greater patient-centricity. From a compliance point of view, it makes a lot of sense to give the patient flexibility to use their preferred device, which they’re familiar with and are most likely to keep charged at all times. Data can be collected in real-time as the patient’s own device is likely almost always with them. BYOD is particularly useful for data collection in the form of diary entries. When we consider the benefits of BYOD in comparison to paper-based collection, it is much more convenient and discreet for a patient to type how they are feeling into their phone rather than write it down in a physical journal.
A randomized 87 participant study conducted and funded by CentrosHealth further proves the higher engagement theory with BYOD design. This study published in March 2016 to determine “Feasibility of the BYOD model in clinical research” was able to establish higher engagement with the study application in the BYOD subgroup.
A major technical challenge in implementing and running a BYOD trial, which has deterred more researches in implementing this in more studies, is the fact that devices of different sizes or which have different operating systems, which may affect the measurement properties of patient reported outcomes (PROs). Therefore, it’s important that equivalence can be proved across multiple devices, but the extent of these requirements is still unclear due to lack of guidance. It is this grey area that prevents many trial sponsors from further exploring the potential advantages of employing BYOD into their trial design. Another common concern is around the practical considerations typically related to data security and possible loss of data as a patient may elect to upgrade a mobile device or change data plan mid-study or switch off in-app notifications.
Fortunately for the industry there has been a growing body of evidence indicating that instrument measurement properties are unchanged when migrating instruments to electronic formats. Researchers at CRF health published one of the first such studies in 2018 discussing the equivalence of measurement of patient related outcome data collected using BYOD compared to paper and a provisioned device. The study provided reassuring results supporting the validity of instrument measurement properties using BYOD.
Future Outlook – how can regulators support?
Despite BYOD appearing to offer many clear advantages many sponsors still have concerns about whether BYOD is a viable option when compared with other tried and tested electronic approaches, primarily because regulators haven’t yet released any formal guidance on BYOD trials or reviewed new drug applications including BYOD data. A major question for researchers is whether the data captured as evidence will be accepted at approval stage.
Though regulators both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have shown their support for remote patient research and the use of electronic tools to collect patient data in their guidance published in 2013 and 2005 respectively, the industry needs a more specific assurance for BYOD from the regulators. It’s high time regulators address the need to use BYOD methodology in more trials to make them more patient centric as well as bringing the overall cost down for the trial. At the end of the day the most desirable outcome for any regulator, sponsor and CRO is to make trial participation and the collection of robust clinical data more convenient for trial participants.
- Feasibility of the “Bring Your Own Device” Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool. (Published online 2016 Mar 16. doi: 7759/cureus.535)
- 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)
- US Food and Drug Administration Guidance for Industry Electronic Source Data in Clinical Investigations. Food and Drug Administration, 2013.
- European Medicines Agency. Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. London: European Medicines Agency, 2005.