For years, the idea that electronic patient-reported outcome (ePRO) tools deployed on a patients’ own device could streamline data collection for clinical research has been considered just beyond the industry’s reach. Many believed bring-your-own-device (BYOD) strategies, where patients use their own devices to collect data within the context of a clinical trial, were not a worthwhile investment.
However, the future is here. The industry’s challenge of efficiently gathering, analyzing, and reporting data is being alleviated by the swift adoption of these technologies: Patients are reporting clinical trial data themselves, in real time, and on their own, personal mobile devices.
In fact, not only does patients’ willingness to use their own devices appear to be strong, a study[i] we conducted recently demonstrates that BYOD patients prefer to use ePRO applications on their own devices over provisioned devices.
What Do Patients Think About BYOD?
In a recent study involving 155 patients with some form of chronic pain, 94% of study participants reported they were willing to download an app to their own device for use in a clinical trial. Of these patients:
Cost & Convenience: The benefits of ePRO on patient-owned devices
Implementing a sound BYOD approach enables a multitude of advantages, making this model appealing to patients, sites, CROs, and sponsors.
For patients, the convenience of using their own device is significant:
- No learning curve to understand a new device
- No need to keep track of an extra device
- No trips to a site to pick up or return a provisioned device
For sites, having patients enter data on their own device:
- Eliminates provisioned device distribution and inventory management
- Reduces hardware costs, shipping fees, and replacement expenses
- Removes the burden of training staff and patients on a new device
For sponsors, BYOD strategies allow them to:
- Collect patient data consistently and more efficiently, eliminating SDV and SDR
- Improve study compliance and engagement among sites and patients
- Implement a data solution that has been proven to be equivalent to provisioned devices[i]
Implementing BYOD ePRO: What’s stopping us?
Despite the advantages, the industry battled reluctancy toward BYOD study strategies. Generally, the idea that patient behavior regarding BYOD will affect data quality has contract research organizations (CROs) concerned about:
- The breakage, loss, or upgrade of devices during the trial
- The accidental deletion of the app or silencing of notifications
- Unwillingness of patients to use their own data plan or storage space for data collection
Many of the common concerns about BYOD are compounded by the lack of guidance on what is acceptable. Although there is no official declaration — either for or against its use — by the FDA, it is willing to have conversations about BYOD on a study-by-study level. And given the agency’s push to move away from paper-based trials, it is even likely that the FDA would look favorably on a trial deploying BYOD for ePRO, particularly where the alternative would be paper-based collection. To be successful, however, studies using this approach should allow time to get agency feedback early in protocol review for your study population.
Consider Starting With a Hybrid BYOD Approach
A hybrid model offsets risk by including a percentage of provisioned devices, which allows researchers to realize the cost savings and other advantages associated with BYOD while still providing provisioned devices for patients who aren’t able to use their own device, or who don’t own a smartphone.
To date, there have been multiple studies that have made regulatory submissions with BYOD-captured primary endpoint data despite the FDA being largely silent about BYOD trials. In fact, there is an increasing number of trials that have successfully deployed this model with great results.
Getting Started: What to look for in a vendor
Sponsors or CROs considering a BYOD strategy would do well to consider using a qualified and BYOD-experienced vendor that can help evaluate the risks and opportunities — particularly one that can:
- Help them work through the regulatory concerns and with copyright holders
- Help them determine the appropriateness of a BYOD approach
- Offer assistance and training to sites
- Provide a 24/7 help desk, offering support related to installing the app and training the patients
- Proactively update its core software
Not only can the right BYOD strategy help researchers and CROs save time and reduce costs, ePRO technologies deployed in this manner are bringing more convenience to the patients in their trials. Reach out or download this white paper to learn more about how BYOD and hybrid studies deployed in the right situation can bring you significant advantages.
[i] 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, 2018. https://www.valueinhealthjournal.com/article/S1098-3015(17)33615-X/pdf.