New and refined technologies have allowed for novel data collection strategies in clinical trials. “Virtual” visits allow for clinical trial teams to collect data remotely where possible, removing the need for participants to travel to the trial sites for in-person assessments. Trial staff can meet with participants through telehealth tools, perform the consenting process, and collect trial data without the participant ever having to set foot in the trial site.
Virtual data collection offers many benefits, so the use of these strategies has increased over time, as has acceptance of participant-reported data as reliable. The need to maintain clinical research momentum in the face of restrictions due to the COVID-19 pandemic has accelerated the adoption of these strategies. We will explore the benefits and limitations of these methods in this blog series, but first, let’s clarify some of the buzzwords that you may be hearing.
Electronic data collection (EDC) refers to a system of electronic case report forms (CRFs) on which to record trial data. The EDC system contains the trial’s database, but provides a simple interface for trial staff to enter data from participants’ records or procedures. EDC replaces paper CRFs, which would have to be scanned or transcribed into the trial database, adding extra steps to the process and a higher likelihood for errors to be introduced. EDC systems are used for traditional trials as well as virtual trials.
Virtual clinical trials are trials where all of the trial data can be collected from participants remotely, without requiring visits to a trial site. Data may be collected through tools like telehealth appointments, smartphone apps, web portals, wearable sensors, or home visits by nurses.
Obviously many clinical trials require exams or procedures that can only be done in a clinical setting (e.g., a device implant procedure). A trial can still benefit from the use of remote data collection where appropriate while decreasing the burden on participants and caregivers. Trials that are designed with a mixture of in-person visits and remote data collection are known as hybrid clinical trials.
Remote data collection strategies are collectively known as electronic clinical outcomes assessment (eCOA), and may include:
The need for virtual and hybrid clinical trials is quickly evolving and necessary during this time. Our next post in this series will discuss how eCOA tools can help simplify data collection and achieve clinical trial objectives for sponsors.