Plenary 3 - Quantification in Trials, Analysis & Standardisation-Plenary 3 - Quantification in Trials, Analysis & Standardisation

Plenary 3 - Quantification in Trials, Analysis & Standardisation

Video Transcription

Video Summary

The speaker outlines the role of clinical trials in drug development and how imaging, especially MRI, fits into them. Drug development is long, costly, and moves through four phases: phase 1 focuses on safety, phase 2 on efficacy and dose-finding, phase 3 on proving clinical benefit, and phase 4 on post-market surveillance. He stresses the difference between true clinical endpoints, such as death or heart attack, and surrogate endpoints, such as imaging measures, which are earlier, more frequent, and cheaper but must be validated against real outcomes. Quantification and standardization are essential for reliable, multi-center trials, along with accuracy and precision. Cardiac MR offers powerful, noninvasive, quantitative measures, but its limited availability, technical variability, and patient constraints reduce its practicality for large global trials. The talk ends by highlighting both the strengths and limitations of cardiac MR in clinical research.

Keywords

clinical trials

drug development

MRI imaging

surrogate endpoints

cardiac MR

quantification standardization