eSource Bootcamp- Wheel of Change

Written by Jessi Lanuza, Associate Director of Business Development

4th eSource in Clinical Investigations Annual Bootcamp

Sponsors, Sites, and Vendors converged on Philadelphia, PA last week to discuss the current status of eSource (Direct Data Capture) in clinical trials, the hurdles to overcome, and the future. Day one focused on the reasons to do more eSource in trials. Themes included bringing the data collection closer to the patient to reduce errors and how everyone from Investigators, that are currently doing double data entry, to Executive Management, that need to see data and understand the true status of their portfolio at any given time, will benefit. It was widely agreed that everyone wins in a direct data capture model. It was not however, widely agreed on how to move forward.

Michelle Crouthamel (GlaxoSmithKline) and Dan Milam (Society for Clinical Research Sites) started a lively discussion in their jointly hosted workshop. Site Representatives in attendance said they are ready for direct data capture now. Some sites have even begun investing in the technology themselves which made some Sponsors in the room nervous. Their concern is around the potential for these sites to be taking in data from multiple systems in a single study. The spirited conversation highlighted the need to roll out direct data capture sooner rather than later.

Day Two focused on the practical matters of getting started with eSource. Tom Haag of Novartis brought in the metaphor of a wheel to help drive home the point. “The wheel of change has already begun rolling, there is no stopping it.” His wheel of change model for bringing technology into an organization not only took into account the many different stakeholders that must be involved, but left room for growth and discovery of the questions we don’t yet know to ask.

Cmed shared how, as a tech-led CRO with our own eSource platform, we are re-imagining clinical trials with eSource. Immediate access to data means greater safety. With zero transcription time-lag using eSource, protocol deviations can be spotted far earlier, as can the inclusion of ineligible patients. eSource data allows for remote monitoring with less on-site CRA time, perhaps new roles for hybrid Clinical Data Managers and less duplication of CRA and DM work. Collecting data bedside means far less errors, queries, and faster data base locks at the end of a trial. Overall, Cmed is looking to fundamentally change clinical trials through the use of eSource, reducing timelines and budgets, ultimately getting products to market more quickly.

Regulations and various regulatory bodies were also hot topics. While the FDA has encouraged eSource and EMA has provided guidance, there have been a couple of roadblocks from individual countries, but as the wheel metaphor suggests, eSource has already begun rolling and these roadblocks will soon be cleared.

I too, believe the wheel of change has already begun. I think it really started years ago with the introduction of eDC. Sponsors large and small, as well as sites, are beginning to see how direct data capture can truly deliver on the failed promises of eDC. In time eSource will become mainstream.