13 May AI in clinical trial adherence and retention: Is it a Pandora’s box?

Clinical Trials Arena demystifies how AI can potentially help participants stick to the study all the way to the end, while also pointing to clinical trial sponsor blind spots.

By Urtė Fultinavičiūtė, Clinical Trials Arena

Clinical trial participants adhering to the study protocol and the risk of patients dropping out are key concerns among study sponsors. Current ways to avoid these scenarios often involve labour-intensive tasks. If efforts to avoid these concerns are unsuccessful, they can lead to study failure.

With such concerns, the potential of artificial intelligence (AI) intrigues the clinical trials industry. However, there are still reservations, such as the fear that AI could be a Pandora’s box, unleashing unnecessary risks to clinical trial completion.

One key concern is how AI fits into the regulatory framework. At present, AI is classified as a medical device by the FDA. However, AI is unique from other kinds of medical devices as AI algorithms have an expiration date, in that they cannot be expected to perform the same way in the next decade, explains Massachusetts Institute of Technology principal research scientist Dr Leo Anthony Celi.

“AI is a living medical product that needs to be constantly tweaked and recalibrated,” Celi adds. AI should be separated from medical devices, similar as to how the FDA separates drugs and vaccines, agrees Duke Clinical Research Institute chief science and digital officer Eric Perakslis, PhD.

While this predicament still needs to be addressed, as do many others, sponsors should nevertheless not shy away from their curiosity about using AI to potentially boost patient adherence and retention. Clinical Trials Arena spoke with AI experts who mentioned potential avenues for AI in clinical trials, but also noted blind spots that sponsors should be careful not to miss. Previously, a different set of experts discussed the untapped value of AI in terms of finding the right patients and recruiting them. Read more …