Digital Tools in Clinical Trials Increase Trial Efficiency and Reduce Errors
[Posted on: Thursday, May 26, 2016]
The latest trend in clinical trial automation is use of BYOD, “Bring Your Own Device”, where a trial participant’s smart phone can be used to collect critical trial activities and data points such as patient diaries, symptoms, adverse events, drug supply management, and scheduling. Last year FDA released a guidance document on electronic informed consent; recently another guidance document on using electronic medical records in clinical trials emphasized the shift towards increasing automation in clinical trials. Electronic data capture is expected to be used in more than 90% of all clinical trials in place of paper case report forms in the next 10 years. All these development seems very welcome however there are still several concerns. The use of private uncontrolled smart phones to collect clinical data raises privacy concerns. It seems patients are increasingly comfortable with using their personal phones to collect data points for a trial but for the sponsor additional measures must be implemented to assure compliance with data integrity concerns. Second, use of diverse networks and devices to collect data raises the cyber security concerns. The data collected is highly dependent on cellular signal quality and reliability of the device. For example, a sponsor needs to plan for device breakdown and maintenance along with upgrades to the device. With the increased availability of good quality cellular signal, wide-spread use of high-speed internet, and secure-cloud usage, these issues are not expected to be major roadblocks in the near future. Some key developments that would happen inevitably are increased remote monitoring of sites, detailed data capture owing to automated data collection by smart devices, and reduced cost and time for trial operations. All we need is a clinical trial work-force trained in modern clinical trial operations that highly rely on automated tools and limit human role to planning and reporting.