Donna Mongiello, RN, BSN, Vice President, Strategic Solutions

50+ years of progress? Who knew? Most of us industry insiders talk about eCOA/ePRO as a relatively recent phenomena – of the past 20 years. During the opening presentation of CBI’s annual eCOA/ePRO conference, we learned that Dr. Warner Slack, the father of what’s now known as the electronic medical record declared “patients are by far the most underutilized resource in healthcare” – in 1967.

While several presenters noted that we’re still talking about many of the same issues as we did in 2007 – such as localization, mode equivalence, and technology implementation, key themes of this year’s conference focused on trends that can make eCOA adoption easier:

Industry veterans Willie Muehlhausen and Celeste Elash discussed the process of Expert Screen Review to replace the process of measurement equivalence from paper to electronic modes when minor changes are involved. A relaxation of the need to routinely conduct these studies is warranted by the hundreds of studies that have proven paper-based PROMS are quantitatively comparable with electronic mode.  That additional equivalence testing is time-consuming, expensive and unnecessary.

The rise of BYOD makes the need for expert screen review more relevant and urgent, considering that it’s not feasible to conduct equivalence studies among all possible devices that may be used in that type of study.

Willie explained expert screen review at a high level includes:

  • Ensuring that the instructions in the electronic format are complete and accurately represent the instructions on the original paper instrument, ensuring the recall period is represented for each item, and ensuring adherence to instrument author requirements
  • Assessing the overall usability of the solution for the target patient population including clarity, navigation, font size, and device usability.
  • And finally, an item-by-item screen review to ensure the industry best practices for faithful migration have been followed

For more information on this same topic, watch a recent webinar presented by Willie and Celeste.

In another presentation on a different topic, Willie argued that voice tech is the one of the biggest trends to watch. Citing positive trends and preferences on the use of smart speakers, he predicted that voice technology will be part of the new standard of patient-reported outcomes, as voice recognition and voice diagnostics are optimized to confirm identification and provide additional support. The combination of conversational AI, voice, and chatbots can transform patient engagement by alleviating the burden of documentation away from the healthcare providers to allow more time focusing on patient care. Adoption challenges always exist, and in this case, they include scientific equivalence and eliminating bias, to ensure the technology doesn’t have an impact on the way questions are answered. Other concerns relate to operational and technical questions about privacy, and the availability of high quality voice technology across diverse patient populations and language. (The Alexas of today struggle with accents). As an industry call to action, Willie urged eCOA vendors to step up, explore implementation and start working on ways to ensure 21 CFR 11 compliance.

While aligning patient-facing technology with eCOA isn’t getting any easier, a panel discussion on this topic moderated by Stan Beaumont reinforced best practices of new technology implementation:

  • Fit-for-purpose is essential to success, stated Joseph Im of Regeneron. Device selection should correlate with the clinical objective, and devices need to be appropriate for the patient population and disease characteristics. “In exploratory studies, sometimes you find out too late that the technology selected is not conducive to the patients and the nature of their disease. You need to think upfront about where to draw the line with data collection fatigue.”
  • Patient and site support are also critical. “You need to monitor compliance,” suggested Megan Turner of GSK, “and provide support appropriately. For example, can the helpdesk truly interface with patients?”
  • Some of the challenges included keeping up with the pace of innovation, while performing the right amount of due diligence, explained Ken Grice of Bayer
  • Sharing data with patients is a popular engagement idea but providing access before the end of the study can introduce bias. Megan recommended to set expectations at the beginning of the study and give participants their data at study completion.
  • Site burden is always a key consideration- from the challenges of managing multiple devices and accessories to finding effective training formats that don’t involve a 90-page user manual.

For the basics of eCOA implementation, Gauri Nagrani reminded the audience of best practices for UAT strategy. We heard about enterprise-level methods to manage and monitor patient compliance through patient-centric design and functionality. A panel discussion and case study tackled the challenges of translations. As clinical trials continue their global reach into new markets, efficient translations require fundamental changes in the way they are managed. We learned that centralized management efforts, instrument libraries, dedicated librarians and a country-specific requirements database helped Abbvie achieve massive efficiencies and take translations off the critical path.

I was honored to preside over such insightful discussions and a knowledgeable, engaged audience. At the end of the day, the room was still packed! As technology evolves, it’s our job as an industry to monitor the progress and seek opportunities to transform site and patient engagement. I look forward to coming together next year and hearing about the progress achieved from this talented group of eCOA experts.