Optimizing Clinical Trials Through Ethical Technology For Non-Technical Users

By Mathew E. Rose, SAAVHA Inc., IEEE Standards Association

The integration of technology, such as sensors, telehealth, remote monitoring, and AI, is becoming increasingly significant in the design and execution of clinical trials, which are pivotal for healthcare advancements. However, it is important to consider how the adoption of these emerging technologies aligns with clinical research ethics and regulatory frameworks.

Since 2000, the National Institutes of Health (NIH) has developed seven ethical research guiding principles. These could be considered when assessing new technology for adoption, along with regulatory requirements like the FDA’s 21 CFR Part 11 (US) and Europe’s Annex 11, as well as unique regional requirements of the participant populations.

Learn more about ethical research practices and how the approved uses of AI technology in the life sciences industry must be developed within a regulatory framework to ensure its meaningful and standardized utility.