How can you assess the effects of a drug if clinical trial participants do not take it as instructed? And how do you know if a participant has truly taken their medication? Those are the issues many clinical trials face, even potentially leading to a trial failure or the demise of an otherwise useful medication.
“AiCure is applying modern technology to this problem,” Ed Ikeguchi, M.D., CEO of AiCure, told BioSpace. “Our study is the first time anyone quantified intentional nonadherence in clinical trials.”
AiCure’s phone app helps clinical trials keep tabs on which participants have taken their medications correctly and which have not. By analyzing videos the app takes, they can also spot who is intentionally not taking their pills, known as intentional nonadherence.
The company recently published a paper and gave a talk at the Drug Information Association (DIA) conference on June 15th about just how bad of a problem intentional nonadherence is.
How can you make sure participants take their pills?
Clinical trial researchers can invite their participants to use AiCure’s phone app. The app tracks the participant’s medication intake and uses the front camera on their phone to record a video of them actually taking the pill.
“The AiCure app helps participants stay true to the protocol regimens,” explained Ikeguchi. “It provides daily pill reminders and walks participants through the stepwise process of taking the medication.”
Using artificial intelligence (AI) and machine learning, it goes through the video frame by frame, recognizing the participant’s face (to ensure the right person is taking the medication), the pill (to make sure they’re taking the right pill), that they’ve put the pill on your tongue, that they’ve swallowed it using a clear glass of water, and that it isn’t under their tongue or in their cheek after they’ve taken it. Check out a video of how it works on AiCure’s website.
What is intentional nonadherence and how do you measure it?
While participants may genuinely forget to take a pill (called unintentional nonadherence), intentional nonadherence is a whole other beast.
It is actually fairly easy to tell if a participant is being intentionally or unintentionally non-adherent using the app. If a participant accidentally misses a dose, they tend to not even open the AiCure app or record their dosage at all. Instead, intentional adherence can be detected by studying the video recorded of the participant taking their pill.