Donna M. Mongiello, RN, BSN, Vice President, Strategic Solutions
CBI’s annual eCOA event took place on Oct 23 in Philadelphia. As co-chair with Ken Grice of Bayer, we presided over a range of eCOA subject matter experts who presented a diverse mix of topics covering technology, operations, translations, wearables, BYOD, quality management and regulatory considerations. Recurring themes and new perspectives within these topics focused on:
Patient Choice and Convenience
The creation of better patient experiences through choice, convenience and simplicity is a hallmark of next-generation clinical trials.
The rise of eCOA goes hand in glove with patient-focused drug development, as do virtual trials and the expanded use of mHealth and wearable devices in clinical trials.
BYOD implementation is always a hot discussion topic at eCOA events. A range of how-to and logistics considerations came up during an operational panel discussion hosted by Gauri Nagrani of Inargan Consulting.
Willie Muehlhausen offered practical expertise from his in-depth experience of delivering and researching BYOD, and shared findings that showed growing evidence supporting BYOD’s scientific acceptability. Concluding that virtual trials won’t take place without BYOD, he also confirmed several assumptions:
- While interest continually increases, hybrid BYOD remains the most widely used model of implementation, using a mix of participants’ own devices with provisioned ones.
- BYOD models clearly increase patient convenience but have not proven to be logistically simpler.
- Patient reimbursement cost estimates for their use of data may be overblown.
Wearables and connected devices offer a balanced complement to ePRO/eCOA data without intrusion to the patient and clinician, and for a longer period of time. Ed Potero of Biogen cited examples currently in development, such as actigraphy and advanced technologies for gait and balance analysis.
Discussions about eCOA implementation revealed that timelines are not only all over the map, but any number of things can drive timeline delays, from unrealistic expectations about development tasks, stakeholder misalignment, poor communications, outdated system development approaches or inadequate project support. Panelists and presenters reinforced that effective project managers need not only be skilled at managing timelines and budget, but they also need demonstrable eCOA subject matter expertise to manage risk, guide system development and set priorities based on country-specific milestone dates.
Damaris Jusino from Eli Lilly and Elizabeth McCullough offered a host of recommendations to reduce eCOA translation timelines to 12 weeks, including process centralization, automation tools, the use of instrument and translation libraries and vendor collaboration approaches.
Data Integrity and Currency
Offering insights from his experience as an FDA inspector, Jonathan Helfgott emphasized data transparency above all other regulatory considerations. He urged the audience to focus on audit trails and access controls as a means to demonstrate transparency and protect integrity. During inspections, Jonathan’s recommendations included providing an inspector with a data flow diagram instead of forcing an inspector to reproduce one. He also recommended that sponsors take advantage of pre-submission meetings to discuss intent, share the data plan and gain agency buy-in.
Data currency, aka real-time access is more important than ever. Janet Connolly-Giwa reminded the audience that the days of reviewing data just before interim analysis are a thing of the past. Sponsors should use available tools to monitor eCOA data in real time for trends, anomalies and compliance patterns, while eCOA providers should operate under the assumption that data needs to be available as a contemporaneous export. Penelope Manasco reinforced this recommendation in a presentation focused on risk identification and monitoring with eCOA implementation.
Overall, there was consensus on increasing regulatory scrutiny and the need to advanced risk management techniques and tools.
eCOA data represent one piece of a much bigger puzzle. The need for data in context, meaning aggregated across multiple data sources and ready for analysis came up in several presentations. Jaime Cook, VP of Technical Delivery at YPrime addressed this topic in detail when discussing data integration and unification. Traditional data integration solutions only offer limited utility as clinical trial complexity and associated data volumes increase. Data unification represents a next-generation solution, by creating critical eClinical systems in a shared environment. Unified systems eliminate costly integration set-ups and data entry redundancy across systems, while saving time and reducing risk.
The future of BYOD is likely to include artificial intelligence and machine learning, as well as blockchain technologies, according to Willie Muelhausen’s future outlook.
Ed Potero offered insights from an exploratory study involving digital biomarkers that was recently conducted at Biogen. Stating that Biogen expects to increase its digital health device (DHD) use by 50% over the next few years, Ed shared a wealth of considerations for DHD global strategy creation that included endpoint selection, stakeholder identification, operational standards, vendor qualification criteria and data analysis, among others.
His discussion on build process requirements and partnership needs signaled burgeoning opportunities for eCOA platform integration, as well as rapidly expanding demand for data science and specialized project management functions in the future of eCOA.
The highly engaged audience came armed with curiosity and thoughtful questions. While industry conferences tend to thin out by mid-afternoon, we still had a packed room after 5pm, when the conference concluded. I look forward to more lively event discussions like this one as eCOA technology evolves.