Innovation in (and access to) mobile technology continues to redefine the clinical trial process as well as shine a light on bring-your-own-device (BYOD) potential. It’s true that allowing patients to utilize their own smartphone or tablet throughout testing can offer some upfront expenditure and convenience benefits. However, each clinical trial’s exorbitant costs and critical significance make it essential for eCOA and ePro providers to take a deeper dive into what a BYOD test entails to ensure they make an informed final decision based on big-picture data.
CROs, sponsors, and site coordinators should consider several essential factors when deciding the best data collection solution for their clinical trials, including:
Most mobile devices have several functional commonalities. However, some of the differences in the smartphone and tablets used throughout testing can have a significant impact on trial measurement. Screen size, pixel resolution, camera capabilities, sensors, and included accessories can all influence how much (or how little) data a patient captures throughout the testing phases.
Downloading clinical testing software onto a patient’s personal device can increase the risk of a cybersecurity breach. Most people spend several owners on their mobile devices, increasing the potential of downloading some form of malware onto their phone or tablet that could impact the clinical software program. Providing a separate device already equipped with only the trial software helps eliminate the threat of the patient inadvertently downloading a virus that can compromise data collection.
At some point, a patient’s device may require technical support to keep it running at optimal capacity. Typically, tech support requires allowing remote access to the device to pinpoint potential issues and performance gaps. Most test subjects may feel reluctant to grant remote access into a personal device where they store private data, personal photos, bank information, and passwords. Additionally, assisting dozens or even hundreds of different devices and operating systems can quickly overwhelm designated tech support resources.
A comprehensive clinical trial includes participants in a wide range of age, geographic, and socioeconomic demographics. However, these factors can directly and significantly influence the results of a BYOD clinical trial. For example, the cost of a device may prohibit some participants from having access to a reliable device. Additionally, while it’s essential to include elderly patients in test groups, some may be using dated technology that would eliminate them from the study.
Both expected and unexpected user variables can also cause significant challenges in a BYOD clinical trial. Several factors can compromise data collection throughout testing, including:
- Changing (or losing) their current device
- Upgrading operating system
- Insufficient storage space
- Inconsistent access to WiFi
- Elimination of user notifications
Data reimbursement also comes into play with a BYOD solution. Patients can’t be asked to spend or lose money participating in a trial, making it essential for CROs to have a detailed plan for reimbursing patients for the data they’ve used on the device throughout testing.
Device Uniformity Streamlines Access, Use, and Results
Many CROs and sponsors quickly realize that device uniformity offers an ideal data capture solution. Providing a designated device to participants allows CROs to maintain increased control over device security and aggregated data integrity. Most importantly, a single device increases a sponsor’s procedural controls of quality and regulatory requirements, better ensuring complete compliance throughout every data phase.
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