Advances in Clinical Trial Endpoints Collection for Parkinson’s Disease Webinar Replay
Panelists highlight clinical examples illustrating the selection and use of imaging for Parkinson’s Disease (PD) studies and wearable sensors technology to capture PerfO COA in PD. They review recent FDA DHT guidance and clinical consortia collaboration on digital outcome measures, data quality management, and the expanding role of wearable devices in decentralized and hybrid trials.
The panelists discuss:
- Regulatory frameworks, including consortia groups’ positions or recommendations for evaluating and validating device-driven data capture and digital outcomes measures, and approaches to validation to support endpoints in clinical trials, e.g., FDA, DIA, C-Path, Dime and ISPOR
- Advances in neuroscience imaging and analysis that characterize clinical findings in PD
- Enhancement of established PerfO outcome measures: how wearable sensor technology provides deeper insights to establish COA in PD trials
- The role of mobility-related sensor technology in decentralized trials
- Applications of wearable sensors in assessing PD data safety and efficacy
The panelists’ review case studies that include findings from the field, clinical trial protocol development, and outcome measure alignment.