Using Artificial Intelligence Platforms to Monitor and Identify Early Nonadherence Activity Based on Visual Confirmation of Medication Ingestion
In this poster you will learn:
- To date, most clinical trials have relied on scheduled pill counts and self-reported data to monitor drug compliance, even though these data are unreliable and tend to overestimate adherence. Pill counts routinely indicate levels of adherence above 95% across therapeutic areas.
- One alternative has been measurement of concentrations of a drug or its metabolite; however, between-person variability in pharmacokinetics (PK) and limits on the frequency of blood sampling prevent this approach from providing accurate day-to-day information on adherence.
- When an investigational drug fails to demonstrate a beneficial effect in a clinical trial, it is difficult to determine whether the drug is truly ineffective or whether the drug worked suboptimally in the trial because subjects in the trial were nonadherent. Nonadherence results in reduced signal level and diminishes the ability to detect an effect.
- The artificial intelligence (AI) platform (AiCure, New York, NY) uses software algorithms on smartphones to visually and automatically confirm participant identity, the medication, and medication ingestion. Participants receive automated reminders and precise dosing instructions. Study teams have access to real-time data for review and intervention.
- A recent phase 2 study (ClinicalTrials.gov identifier NCT02477020) was completed in the United States that evaluated the efficacy, safety, and tolerability of treatment for 6 weeks with TAK-063 compared with placebo in subjects with acutely exacerbated schizophrenia. Study subjects were required to remain confined for the first 3 weeks of the study. At any time after the week 3 visit and if deemed to be clinically stable by the investigator, subjects were allowed to complete the study as an outpatient. The outpatient segment from this phase 2 clinical trial provided an opportunity to investigate study drug compliance in subjects discharged from the hospital and followed up in the outpatient portion of the study using the AiCure platform.