By the end of the year the U.S Food and Drug Administration (FDA) plans to hold at least one public meeting and to release guidance on digital health technologies (DHT) to be used in drug clinical trials. The announcement comes amid concerns about whether DHT are accurate and reliable enough to gather data for the drug development process.
In terms of DHTs, consistent policies across review centres is a major issue. According to a framework published on the 23rd March, the FDA has established a steering committee with staff from its drug, device, and biologics review centres as well as its Digital Health Center of Excellence and its Oncology Center of Excellence to ensure consistent policies across the agency.
In addition to the steering committee, the FDA plans to continue to improve internal expertise, providing training in the area of DHTs, as well as investigating statistical considerations when DHTs data is used to analyse patient data, and the IT capabilities needed for DHTs.
The FDA has already published draft guidance on some DHT topics, with plans to publish more by the end of the year. The first of five external meetings will be held by the end of Q2 2023, discussing topics such as what to prioritise when developing DHTs, and what approaches to take when verifying and validating DHTs.
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