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International Clinical Trials

Thinking Allowed

: Validation is a long-standing concern for ePRO – how much of an issue is it for trials today?

Emily Cantrell: ePRO often provides higher quality data, but it can be a challenge to implement. If you are using ePRO for a pivotal trial or the data is likely to be used in a marketing application submission, it is likely that validation will be necessary. In addition, if you are using ePRO to collect your primary endpoint, validation may be needed.

Validation costs are typically not included in bids from ePRO vendors. A third-party vendor is often required to perform the validation and the costs can be significant – at more than $50,000 – so be sure to budget accordingly.

What are the key considerations for implementing ePRO and smart devices in studies?

We would give three key tips. Firstly, determine early in the site feasibility and qualification process if sites are prepared to use ePRO. Look for potential issues during the site qualification visit, so you can address them early in the study. Secondly, training is critical for the study team, site staff and investigators. Make sure everyone is comfortable using the devices involved. Finally, have a paper-based back-up system and understand how paper data will be transferred to the ePRO system. Be clear during training under what conditions sites should utilise paper back-ups.

You recently carried out a large trial using tablets for ePRO – tell us more.

Over the past 18 months, we have been working on a study that utilises ePRO on tablet devices for a large Phase 3 pain trial. The devices were kept at the sites and participating subjects only entered data during study visits. For other studies that use ePRO for diary data (where subjects take the devices home and enter data on their own), specific training plans need to be devised with sites for their subjects, but this makes for a trickier plan.

What study and site issues did you encounter?

The devil was in the detail. Validation costs were not included in the ePRO vendor’s bid; they were an additional cost we were not expecting. A number of sites did not have reliable Wi-Fi access, so we ended up providing mobile Wi-Fi hotspots. Also, our vendor made a decision to upgrade devices and change its stylus between when we signed the work order and our study going live, which created some logistical headaches.

What ePRO lessons did this study flag up?

Based on our experience, we would advise the following. Carefully review vendor bids to make sure everything you need is included. Make sure sites are prepared, with Wi-Fi access, a place to store and charge the devices, and staff who are comfortable using the system. Provide thorough hands-on training to the study team, site personnel and investigators.

We would also recommend being involved in user acceptance testing, and to consider how support will be provided. In our case, we provided frontline support, rather than directing all calls to the ePRO vendor.

Where do you see ePRO heading over the next decade?

As more studies and sites use ePRO and become familiar with it, a wider adoption should develop. Hopefully, device costs will decline and a library of common forms will become available versus building each study from scratch. More robust solutions for uploading data should be introduced, which will help too.

We have received feedback that older subjects are less comfortable with using tablets and the technology that goes with them. In the decade ahead, a generation more familiar with technology will be moving into clinical research studies – and this will evolve ePRO further.

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Emily Cantrell is Senior Director, Operations at full-service CRO, Rho. She has extensive experience managing clinical trials in a number of therapeutic areas, and recently served as the Project Advisor for a large Phase 3 pain study using ePRO with tablet devices.
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