Emily Cantrell, Senior Director Operations, and Becky Baggett, Senior Project Manager recently completed enrollment six weeks early on a phase 3 study using ePRO with a tablet.
On June 10th, we hosted a webinar featuring a case study using ePRO with a smart device. If you missed the webinar, you can click here to register and view the webinar on-demand.
Several questions came up during the webinar that we did not have time to address. Below, we’ve responded to the unanswered questions that were submitted during the webinar.
Q: You mentioned that the guidance on Equivalence Validation is vague and your decision to include was a conservative approach due to the trial being a Phase III pivotal. Can you provide additional comment on when EV will and will not be required?
A: It is difficult to say when this equivalence validation should or should not be performed; however, the impact of the data collected for your marketing claims may help you decide. In our case, since our primary efficacy endpoint for our pivotal phase III was captured on the tablet, the Sponsor and Rho felt it was an important step in support of the data validity. At the time this was a very expensive decision, but it may be the case that the vendor has PROs in their library that have previously been validated, perhaps reducing the impact of cost on your decision.
Q: Are you aware of any tablets that utilize thumb print technology in lieu of a subject PIN?
A: We did not use this technology for our study nor have we been presented with this technology from our vendors.
Q: Can you comment on smart phone apps and other methods for patients to do ePRO at home?
A: Rho does have experience working with a vendor that issues smart phones as at-home devices. The challenges here are ensuring the subjects keep the batteries charged, take care of the device and remember to enter their outcomes. To date, Rho does not have experience using a smart phone application, but we are exploring this option. We have learned that many of the challenges one would experience with the average smart phone technology may complicate the use in clinical trials as well. For example, subjects may inadvertently delete the app from their phone, operation system upgrades may change the way the app interacts with the user, or subjects may lose or damage their phone. One other point of consideration is how subjects may be compensated for the use of their data plan.
Q: Does validation have to be specific to the exact device such as an iPad vs a smart phone app vs another tablet type?
A: In our case, we utilized the exact device with the validation subjects to ensure they were reviewing exactly what the study subjects would be using. For studies that have VAS outcomes, Rho would strongly recommend using the exact device to ensure that the size and scaling did not impact the outcome. For NRS or simple questionnaires, it’s not as pressing, but Rho would recommend obtaining the vendor's prior experience interacting with the FDA to inform the decision.
Q: Do you have experience using an app vs a separate device?
A: To date, we have not yet had experience with using an app versus a device. We realize there may be challenges for this and would want to carefully weigh the options with the Sponsor and study team during study start-up.
Q: How is the translation vendor selected? Does Rho typically select the translation vendor, or do you leave that up to the sponsor or ePRO vendor?
A: Rho has preferred providers for translation, and we do a cost comparison for each bid. There are times where the vendor has been selected by the Sponsor, so we will use their vendor.