The FDA has announced several guidelines and plans to hold at least one public meeting on digital health technologies (DHTs) to be used in drug clinical trials by the end of the year. However, inconsistent DHT policies have been a major issue across review centres.
Drug development process questions the reliability and accuracy of DHT products. FDA has formed a steering committee consisting of its drug, device, and biologics review centers to ensure consistency. Additionally, it has created two centres of excellence: one for digital health, one for oncology.
The agency says it will review and evaluate DHT-related data, hire more people with the right expertise, and examine IT capabilities required for DHT use.
FDA plans to convene five public meetings to discuss DHTs use in clinical trials. The meetings will explore topics such as what to prioritize when developing DHTs, and what approaches to take when verifying and validating DHTs.
The FDA has issued several draft guidelines on DHT use in clinical trials, but there are concerns about whether the plan will address the biggest issues faced by the medical product development industry.
There is hope that the agency will develop consistent policies across CDER and CDRH reviews and not just within CDER.