Last week, the Food and Drug Administration (FDA) released guidelines for remote data acquisition in clinical investigations. The draft report focused on best practices for stakeholders that use digital health technologies to collect data from participants in clinical investigations evaluating medical products.
The following are some of the considerations outlined in the report for those using digital health technologies to collect data in this manner:
- Technology selection, factoring in investigation population, DHT design and the appropriateness of participants’ own tools, as well as how to explain the tools’ suitability in submissions.
- Verification, validation and usability of the technology.
- Using tools to collect data for clinical endpoints.
- Technology risks, such as those concerning physical well-being, privacy and informed consent.
- Record protection and retention.
The ability to collect data remotely is not only useful during times of the pandemic to limit virus exposure for the clinical teams and the participants, but also has the ability to minimize equity issues in data collection. Currently, medical data is predominantly Caucasian resulting skewed data sets. Remote data collection removes barriers for potential participants such as geographical distance and physical limitations. The hope is that this new trend will enable more frequent and continuous data collection and a broader range of participants, providing health professionals with a more accurate picture of the population in clinical investigations.
You can read the draft report here. The FDA is asking for comments and feedback on the draft by March 22, 2022.
