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Researchers are now looking to design their trials around a bring-your-own-device (BYOD) strategy, which allows participants in a clinical trial to provide study data using their own internet-enabled hardware.
Advances in digital technology and confidence in the improved study outcomes new solutions can bring, has resulted in a noticeable rise in the number of researchers utilizing eCOA within their studies over recent years. And thanks to the high penetration of technology devices across society, many are now looking to design their trials around a bring-your-own-device (BYOD) strategy, which allows participants in a clinical trial to provide study data using their own internet-enabled hardware. This could be a smartphone, tablet, desktop computer or laptop.
By eliminating the need to source and provision costly devices to the entire patient population-not to mention maintaining, shipping, and distributing to sites/subjects etc.-researchers can clearly see where they could potentially save time and funds with a BYOD approach. What’s more, in addition to providing a cost-effective and resource-efficient means of collecting data, by allowing patients to use their own device you could easily argue the need for support or training may be reduced as participants will already be familiar with the device. Removing the need for patients to carry around an additional device should also mean that the trial can easily fit into their everyday schedule, improving accessibility and usability. Combined, these factors, may improve the patient’s overall experience, and in turn, boost compliance and improve the quality of data captured.
When it comes to selecting how best to deploy BYOD in a study, there are two options available to researchers-web-based or app-based implementation. Web-based BYOD allows patients and sites to connect to the internet via their web browser to complete online versions of questionnaires and access data via their own mobile devices, PCs, or tablets. App-based implementation administers questionnaires on a patient’s own smartphone or tablet device via a tailored, downloadable mobile application. Web implementation is especially well-suited for late phase studies that have a large number of patients and may require infrequent data collection (weekly, monthly or less frequently), whereas app-based BYOD is best suited for studies which utilize a relatively short data collection period (weeks to months), studies that may benefit from the ability to collect data offline and those conducted in patient populations with a high penetration of smartphones.
Despite the approach appearing to offer many clear advantages over other eCOA modalities (i.e. provisioned devices), and with a potential to transform how field-based electronic patient reported outcome (ePRO) assessments are implemented in clinical trials, many in the industry still have concerns about whether BYOD is a viable option when compared with other tried and tested electronic approaches. Learn about evolving clinical technology and strategies to enhance clinical trial efficiencies at CBI's eCOA/ePRO 2018.
Regulators haven’t yet released any formal guidance on BYOD trials or reviewed new drug applications including BYOD data, so understandably, a major question for researchers is whether the data captured as evidence will be accepted at approval stage. That said, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both support remote patient research and the use of electronic tools to collect patient data1-2. The important factors to consider when using BYOD concern the conservation of the measurement properties of validated instruments when used on screens of different sizes, and the technical and practical considerations related to use of the patients’ own mobile devices or computers.
There is a growing body of evidence indicating that instrument measurement properties are unchanged when migrating instruments to electronic formats. Bill Byrom, VP of Product Strategy and Innovation at CRF Health, along with other industry colleagues, 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 device3. This study had provided reassuring results supporting the validity of instrument measurement properties using BYOD.
Common technical and practical considerations around the use of BYOD typically relate 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. Our experience to date, however, has indicated that diary completion rates are at least as good using BYOD compared to provisioning-suggesting that these possible factors are unlikely to have an impact on missing data. It 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’s practical to build all necessary security and protection controls into the trial software, whether it is delivered through a personal or provisioned device. With breaches of cyber security often making headlines, it’s only natural that some patients will be uncomfortable sharing health data via an app, which they may not think is completely secure. It is the role of researchers to reassure study participants that the software is secure and is not accessing additional data through clear and comprehensive training and a clearly-worded informed consent process.
Ensuring your study is free from bias due to technology ownership is also an important factor with BYOD studies, to avoid the potential criticism that the study sample does not effectively represent the patient population. Although the prevalence of smartphone ownership is increasing, it is unlikely there will ever be total saturation of appropriate devices in any target sample, especially if a study includes participants in developing countries or regions. To counteract this issue, sponsors should consider implementing a “partial provisioning” strategy, where patients who own smartphones enter their data using the app or web on their own device, and those that don’t have a suitable device or are unwilling to use their own are provided with a dedicated device to do so.
Finally, careful consideration of site and patient acceptance of the use of BYOD is a critical success factor.
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.
CRF Health’s scientific experts are able to offer comprehensive advice and support to sponsors choosing between BYOD and provisioned approaches to ePRO implementation and can support discussions with regulatory bodies where required. Please contact the CRF Health team to talk to an expert.
1. US Food and Drug Administration Guidance for Industry Electronic Source Data in Clinical Investigations. Food and Drug Administration, 2013.
2. 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.
3. 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
About CRF Health
CRF Health is the leading global provider of patient-centered eSource technology solutions for the life sciences industry. With experience in more than 800 clinical trials, over 100 languages and across 74 countries, the company delivers best in class, fully integrated eSource solutions for pharma partners. Solutions include TrialMax®, an eCOA suite which consistently demonstrates the industry’s highest data accuracy, patient and site compliance, and patient retention, and TrialConsent®, the patient-centered, intuitive and interactive informed eConsent suite. Learn more at www.crfhealth.com.
Bill Byrom, PhD is VP, Product Strategy and Innovation at CRF Health.