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 your study team.
If you've never set up an ePRO clinical trial, though, it takes some time up-front to plan for success. 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.
Once you have a basic protocol idea in mind, it's time to start connecting with potential ePRO vendors. Your vendor can help you navigate FDA guidelines for ePRO development, and create mockups of your system along the way so you can have hands-on experience with the tool in the development process. Expect to go back and forth a few times with your vendor before settling on a format you like.
2. Consider a bring-your-own-device (BYOD) trial.
Some ePRO vendors provide devices loaded with your ePRO technology, while others offer an app solution that can be used on any device. Both options have benefits and drawbacks, from patient usability to cost issues.
For one, when deciding whether or not 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 will require them to look at graphs or other images with small text, a tablet might be a better choice than a smartphone, and you may want to provide tablets to patients.
If you have several different sites where you'll be recruiting patients, consider whether you anticipate recruitment challenges at any of them in particular. If you choose to provide patients with devices, you may waste money by ordering too many devices for sites that don't meet recruitment goals. BYOD may offer your trial more flexibility.
3. Find a company that integrates easily with your IWRS.
Once your clinical trial starts, your team will need to connect patient data from your IWRS with the information patients share in their e-diaries. If data needs to be reconciled manually, that introduces the risk of human error, cancelling out one of the main benefits of using ePRO in the first place.
Darja Turner, a clinical psychologist, shared her experience using ePRO for the first time.
“This will deliver fewer errors, reducing frustration and costs," Turner told Eye For Pharma. “However, some integrations may increase the trial timeline, so plan accordingly."
Some IWRS companies also provide ePRO, so if you're in the market for both, consider finding a vendor that also works with IRT systems.
4. Provide patients with a training guide as part of their app or study materials.
Even though smartphone use is quite ubiquitous now — 77% of Americans now use them — it's still important to provide guidelines on how to correctly use your 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 your IRB. Eye for Pharma provides a helpful list of the support materials they put together for a study.
5. Learn everything you can from user acceptance testing.
Before submitting all of your ePRO materials to your IRB, it's important to take plenty of time for user acceptance testing (UST). UST ensures that your ePRO meets the requirements outlined by your study. The ISPOR ePRO Systems Validation Good Research Practices Task Force put together a thorough guide to user acceptance testing for ePRO. You'll work closely with your ePRO vendor throughout this process, too, and may need to make adjustments to the instrument they created.
When your ePRO trial is set up and ready to start enrolling patients, Antidote can help. Download our cases studies to learn more about how we connect patients with research.