Real-Time Patient Safety Monitoring in Clinical Trials
1:00pm - 2:00pmWednesday, February 13
Orlando - Orange County Convention Center
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.