USING ARTIFICIAL INTELLIGENCE PLATFORMS TO ENHANCE STUDY DESIGN IN SCHIZOPHRENIA TRIALS

Background Remote patient monitoring is critical in ensuring optimal drug exposure. Between 30–50% of CNS trials fail because patients are not following the assigned protocol. It is estimated that non-adherence based on pharmacokinetic (PK) data is as high as 39% in schizophrenia trials. An AI platform that uses software algorithms on smartphones to visually and automatically confirm medication ingestion has been used extensively in schizophrenia trials, phases I-IV. Aggregated data demonstrate the feasibility of using the technology in patients with schizophrenia – where smartphone ownership is estimated to be well above 50% - and the potential value of enhancing study design through predictive data and statistical power.