Session ID: 
151

Real-Time Patient Safety Monitoring in Clinical Trials

1:00pm - 2:00pm Wednesday, February 13
Orlando - Orange County Convention Center
W314B

Description

The Salford Lung Study used innovative data collection methods, combining directly extracted electronic healthcare records (EHR) along with more standard methods. Due to the study’s broad inclusion criteria it was anticipated that patients would experience more serious adverse events (SAEs) than in standard trials. Safety reporting was achieved by the remote monitoring of patients’ EHR using a unique information and technology infrastructure. This bespoke IT infrastructure enabled safety events captured in the patient’s EHR to trigger an alert to the research team. This method of safety monitoring resulted in safety events being reported near-to-real-time, enabling safety signals to be detected more quickly than in standard trials. The integration of multiple data sources available to the research team allows more comprehensive safety data to be collected at the point of the SAE submission. This new approach has the potential to set a new standard in safety reporting for clinical trials of the future.

Learning Objectives: 

  • Justify the need for a different type of clinical trial data
  • Describe what made the Salford Lung Study so pioneering in its research methodology
  • Analyze patient safety monitoring challenges and how to use Real World Studies to assess the effectiveness of new drug therapies
  • Explain the bespoke IT infrastructure use to support the safety monitoring and reporting during the Salford Lung Study
  • Appraise the impact of ‘near to’ real time safety monitoring on the future of clinical trials

Speaker(s): 

Head of Pharmacovigilance,
NorthWest EHealth

Audience: 

Clinical Informaticists
Government or Public Policy Professional
Research and Development Professional

Level: 

Introductory