(Bring Your Own Device)
Imagine a trial where patients simply use a configurable, electronic patient-reported outcome (ePRO) app on their own smartphones to record all the data critical to your study. Clinical Ink is the bring your own device (BYOD) leader; we have BYOD experience with 15,000 patients in Phase I–IV+ trials. Additionally, we can commit to rapid build times during the COVID-19 pandemic.
Today, exploring new models for executing studies is critically important. While an increasing number of trials are successfully deploying BYOD with great results, some CROs and sponsors wonder about logistics and regulatory considerations. We’ll answer all your questions and address your concerns.
While much of the world is powered by modern smartphones, aligning your solution with that power and leveraging those devices for BYOD takes experience and know-how. To tap into BYOD’s promise of higher-quality data and better patient experiences, you need an expert partner that understands the intricacies of global operations. As the industry leader in BYOD solutions for ePRO and patient engagement, Clinical Ink will support you with nuanced evaluations of your target populations. We will judge how well they are likely to adapt to BYOD and what it will take to support the technology in their locale.
You can rely on our outcome solutions team to determine whether a BYOD approach is right for your study. We’ll assess the technology proliferation challenge, pressure-test your protocol requirements for endpoint efficacy, and evaluate any relevant copyright-holder use requirements. Clinical Ink will then help you deploy an ePRO and patient engagement solution purpose-built with the functionality to meet the demands of your specific protocol, rapidly.
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In one Phase III clinical trial, 90% of the 275 enrolled subjects utilized their own phones to submit their data at 16 time points per day for three days, two weeks apart.
Powered by a BYOD solution, the study achieved an astounding overall compliance rate of 98.3% with 86% of subjects being 100% compliant.
The biggest challenge facing clinical research today is the need to gather, analyze, and report vast quantities of data. This takes time. Electronic patient-reported outcome (ePRO) tools that patients access on their own familiar devices save time and energy in a wide variety of clinical trials because:
- All functionality of ePRO is retained: notifications, date/time stamps, branching logic, and edit checks
- With no need for transcription and with full remote access to all the data collected, no source data verification is necessary
- Real-time data collection and monitoring eliminate any need to email or physically deliver forms
- Modality remains constant; electronic data collection and analysis continue without disruption
- Inventory management and costs are reduced or eliminated
- In hybrid deployments, BYOD can be supplemented with provisioned devices as needed
BYOD significantly lowers — and eliminates, in some trials — costs associated with data plans, shipping, lost or unreturned devices, and the overall logistics of inventory management. For a large trial, these savings could mean hundreds of thousands of dollars.
Convenience for Patients
Patients prefer their own devices. There’s no learning curve to understand a new device, no need to keep track of an extra device, and no trips to pick up or return a provisioned device. Furthermore, your app will always be on hand: Few smartphone users are willing to part from their phones for very long, but the same can’t be said for provisioned devices.
BYOD patients consistently use their ePRO applications more often than patients using provisioned devices. In an early case study conducted on the Lumenis™ platform, patients leveraged the BYOD solution twice as often and for twice as long as patients using provisioned devices — benefiting sites, CROs, and sponsors.
Training and 24/7 Help for Sites
With BYOD, up-front training is crucial. Site personnel need to know how to install the app and train the patients. Clinical Ink not only provides initial training but backs up that support with a 24/7 helpdesk staffed by trained Clinical Ink professionals. When questions arise about handling smartphone upgrades, or what to do in the case of loss or damage, sites will always have the answers.
Robust Platform and Rapid Build Times
The Lumenis patient engagement and ePRO application is both Apple iOS and Android compatible. We proactively update our core software and ensure that it aligns should patients upgrade their smartphones during a trial. Even if they switch between a provisioned device and their own, study patients can pick up where they last logged in, no problem. Plus, our platform enables the industry’s fastest build times.
Clinical Ink has the experience to help you evaluate the risks and opportunities BYOD presents. While it’s true the FDA has not provided any specific guidance on BYOD indicating support, it’s also important to note they have not delivered any guidance indicating objection. The agency has, in fact, indicated a willingness to have conversations about BYOD on a case-by-case basis when relevant. Multiple studies have made successful regulatory submissions with BYOD-captured primary endpoint data. Given the agency’s push to move away from paper-based trials, a favorable view of BYOD makes sense, especially where the alternative would be paper-based.
Virtual Trial Support
Clinical Ink is the leader in virtual and hybrid virtual trials. Implementing a virtual eSource platform wherever possible can ease operations and facilitate rapid, safety-conscious, cost-effective research. BYOD is an important tool for communicating with patients, capturing and sharing their inputs efficiently, and maintaining patient engagement for better adherence and retention throughout your trial.
A Closer Look
What if your patients break their phones, delete the app, turn off notifications, don’t want to use their data plan, run out of storage space, or don’t even have smartphones? These concerns are largely addressed through our software, or through a hybrid hardware model in which a percentage of provisioned devices are included as part of the de-risking strategy. As the industry leader in BYOD, Clinical Ink is uniquely positioned to help you plan for and navigate all these scenarios.
Care for Measuring Equivalency
Ensuring equivalency remains a significant concern for sponsors and CROs considering ePRO trials, particularly ones using a BYOD approach. Hundreds of studies and several meta-analyses have shown high levels of agreement between paper and electronic modes. Across the board, in our application of the Lumenis™ platform, we’ve seen incredible constancy regardless of the use of patients’ own smartphones or provisioned devices. Further, our platform has been utilized in a preliminary study evaluating equivalence in standard patient-reported controls. In that study, there was no statistically significant difference shown in implementations between provisioned hardware and patients’ own smartphones.