Clarkston Shares Guest Column about FDA Guidance on Electronic Systems in Clinical Investigations
February 28, 2025 | Clarkston Consulting’s Laurie Stone and Randall Jacobs recently shared a guest column with Clinical Leader on the latest FDA guidance on electronic systems in clinical investigations. Read an excerpt below and the full article here.
Breaking Down The FDA’s Latest Guidance On Electronic Systems In Clinical Investigations
“Clinical trials are becoming increasingly technologically savvy, with sponsors and sites integrating technologies such as electronic clinical outcome assessments (eCOAs), electronic patient reported outcomes (ePROs), and digital health technologies (DHTs). While each of these technologies has the capability to revolutionize both patient experience and data collection, they also present a unique set of challenges for clinical trial teams — challenges that can be mitigated with a proper implementation plan … if planned correctly, the clinical team should have corrective action strategies to implement to restore performance of a given technology. As you move throughout the plan, it’s important to highlight pitfalls (as noted above in the implementation strategy) you should take note of, as well as their corresponding corrective and preventive actions. While the future of digital health technologies is exciting, there are still lessons to learn in the field. From compliance to training time and costs and participant burden, digital health technologies come with their fair share of burdens. However, with the correct implementation plan and partners, you can eliminate or mitigate many of these obstacles to ensure digital health technologies help to improve your clinical trial, not hinder it.”