Real Talk, Fresh Takes: How Sage Therapeutics is Unleashing the Operational Value of Real-Time Dosing Data
Sarah Titus, Associate Director, Clinical Operations and Development at Sage Therapeutics
Amanda Paley, Senior Director, Clinical Development Strategy at AiCure
Digital tools hold significant promise for enhancing data quality and odds of overall trial success. Real-time visibility into participant behavior enables sites and the sponsor to be proactive, rather than reactive, during trial conduct. This also enables predictive analytics and robust data to which can determine quick decision-making. Non-adherence is an age-old problem that negatively impacts researchers’ understanding of how the drug works, adds cost and time to trials, and can cause trials to fail. With the availability of digital tools to address this problem and capture patient data in real-time, designing and executing a plan to ensure participants are adherent to the study drug is a critical element of operational success for modern clinical trials.
Join AiCure and Sarah Titus, Associate Director, Clinical Operations and Development at Sage Therapeutics for best practices for improving adherence, ensuring dosing data integrity, and enhancing patient experience across the trial lifecycle, including:
• Study Planning and Setup: Integration of a proactive adherence plan at the protocol development stage with built-in predictive analytics to ensure an efficient trial.
• Study Execution: Focus on dosing support during site and CRA training; decreasing site burden by enabling sites to provide a personalized level of support for each participant based on the Patient Connect app’s ability to flag possible problems in real-time to improve adherence in the study.
• Post-Study Analysis: Dose-by-dose data set provides unique insight into trial results and future trial planning.