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

Real World Evidence (RWE) studies are increasingly being developed to assess the effectiveness of new drug therapies. Standard Randomized Controlled Trials may not expose rare adverse drug reactions that occur after long periods of use or interactions with other drugs. Incorporating RWE at an earlier stage in drug development will enable more accurate safety and risk evaluation prior to market approval, which is of paramount importance in protecting patients’ safety. In this first module of the Life Sciences Forum, learn how the Salford Lung Study used innovative data collection methods combining directly extracted electronic healthcare records (EHR) along with more standard methods, and applied safety reporting through remote monitoring of patients’ EHR using a unique IT infrastructure, resulting in safety events being reported near to real-time enabling safety signals to be detected more quickly than in standard trials. 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): 

Chief Operating Officer,
NorthWest EHealth
Head of Pharmacovigilance,
NorthWest EHealth
Continuing Education Credits: 
ACHE
1.00
CAHIMS
1.00
CME
1.00
CNE
1.00
CPHIMS
1.00

Audience: 

Clinical Informaticists
Government or Public Policy Professional
Research and Development Professional

Level: 

Introductory