Summary
Highlights
The speaker introduces IRT (Interactive Response Technology) as a system similar to an Electronic Data Capture (EDC) system. While confidentiality prevents showing an example, the video aims to explain its function. IRT, also known as randomization and trial supply management, helps clinical trial sponsors and sites manage patient and drug supply logistics, offering control, flexibility, and efficiency.
IRT evolved from Interactive Web Response Systems (IWRS) and even earlier Interactive Voice Response Systems (IVRS). Its primary purpose is to officially track patient statuses such as screening, randomization, early termination, and screen failure. This official record is accessible to sponsors, ensuring accurate study progression.
Early IRT systems began to integrate drug supply management. This allows automatic assignment of drugs based on visit schedules and even automated drug resupply to sites when needed. Some modern IRTs can also adjust dosages based on patient parameters like weight.
Many IRTs now integrate with electronic patient-reported outcomes (e-diaries), managing patient assignments and follow-ups. A significant advancement is the automatic transfer of basic subject data (like demographics and subject numbers) from IRT to EDC, reducing redundant data entry for study coordinators.
The speaker envisions IRT becoming a centralized hub for all coordinator needs, potentially integrating lab supply requests. While some areas like lab vendors, ECG portals, and imaging portals are still separate, the trend is towards IRT consolidating various functions, making it a comprehensive tool for clinical trial management.