Becky Baggett, Senior Project Manager recently completed enrollment six weeks early on a phase 3 study using ePRO with a tablet.

Over the past 18 months, we’ve been working on a study that utilizes electronic patient reported outcomes (ePRO) on tablet devices for a large phase 3 pain study.  We’ll share a number of considerations and recommendations for selecting an ePRO vendor for a clinical study based on the challenges we’ve faced and the lessons we’ve learned.

ePRO is not yet a fully mature technology, so it is likely that you will face some challenges regardless of the vendor you use.

1. Carefully review the bids that you are sent to make sure they cover everything you need.  Did they include validation if you need it?  Did they include enough support time or calls?  In addition to the devices needed for each site or subject (depending on your study set-up), have they included some extras for the study team and for back-ups?
2. Make sure the vendor specifies exactly which device and accessories they will use.  Ask about plans to change or upgrade devices during the course of your study and make sure they have enough devices in stock or readily available to meet your needs and timelines.  We ran into two issues during our study.  The first is the stylus used during the presentation for us wasn’t the stylus the sites were sent (and the quality was different).  The second issue was that the ePRO vendor made a decision to upgrade to a new device between their presentation to us and study live date. The sponsor had already seen the previous device and it was built into the Work Order. This made things more difficult from our perspective.
3. Be involved in user acceptance testing (UAT) for the device. More than likely you will be given a script to follow, but don’t be afraid to test other scenarios to confirm the device is working appropriately. Performing UAT opened our eyes to the fact that some assumptions we made about how the tablets worked were not always true. This was also helpful for the study team to develop the training for the sites and CRAs.
4. Consider how you want to handle support.  The vendor provided technical support was really only helpful if the issue was only technical in nature.  We chose to provide frontline support to sites through our own client support call center.  Using our own client support call center, we were able to weed out training issues and issues related more to the study than the technology while providing better customer service.
5. If you haven’t already selected a vendor, check with site staff you trust.  It is likely that they have previous experience with multiple systems and may be able to make good recommendations.  Even if they don’t, they may appreciate that their perspective is being considered.

Despite all of the challenges,  we still believe it was worth it to use ePRO for our study.  The quality of the data is good, there are economies of scale, and the duration and scope of the study warranted it.