5 ePRO clinical trial best practices
In clinical trials, electronic patient-reported outcomes (ePRO) can be used to capture the patient experience in a way that's accessible for patients and creates usable data for the study team. While using ePRO in a clinical trial can ultimately save time, it is crucial to note that planning for success takes some time upfront. We've gathered a few best practices that can help you find a vendor and successfully set up your first ePRO clinical trial.
1. Begin discussions with ePRO vendors early.
After a study's basic protocol has been outlined, it's time to connect with potential ePRO vendors. Vendors can help with the navigation of FDA guidelines for ePRO development and create mockups of the system along the way to provide a hands-on experience with the tool.
2. Consider a bring-your-own-device (BYOD) trial.
Some ePRO vendors provide devices preloaded with ePRO technology, while others offer an app solution that can be used on any device. Both options have benefits and drawbacks, including patient usability and cost issues. When deciding whether to run a BYOD trial, it's helpful to have a general sense of what patients will be viewing on the devices during the trial. For example, if the trial requires them to look at graphs or other images with tiny text, a study-provided tablet might be a better choice than a smartphone.
3. Find a company that integrates easily with Interactive Web Response Systems (IWRS).
Once the clinical trial starts, the study team must connect patient data from the IWRS with the information patients share in their e-diaries. If data needs to be reconciled manually, that introduces the risk of human error, canceling out one of the main benefits of using ePRO. However, some IWRS companies also provide ePRO, so it may be possible to find a vendor that also works with IRT systems.
4. Provide patients with a training guide as part of their app or study materials.
Smartphone use has become quite ubiquitous, with 90% of Americans now using them — but it's still essential to provide guidelines on how patients can use an ePRO system. Study coordinators should be prepped with a support guide to help answer questions, and a thorough guide with screenshots should be provided to patients and approved by the IRB.
5. Learn from user acceptance testing.
Before submitting ePRO materials to your IRB, it's essential to take plenty of time for user acceptance testing. This testing ensures that the ePRO system meets the requirements outlined by the study, and is something that an ePRO vendor can help with.
When your ePRO trial is set up and ready to start enrolling patients, Antidote can help. Download our case studies to learn more about how we connect patients with research.
