The Rise of Decentralized Clinical Trials - Remote Patient Participation is a Viable Solution for the Future of Clinical Trials - Jodi Akin

7:20 PM - 8:00 PM

Clinical trials are about hope for patients. Yet patient access to trials and ability to complete necessary follow-up visits is burdensome and problematic. Issues are multifactorial and range from geography, health status, economics and even cultural attitudes about healthcare. The system is not patient-centric, is burdensome for investigators and contributes to regulatory challenges. Arguably, the burden of clinical trials translates into the costs and quality of healthcare.

Roughly 89% of clinical trials have key missing data, and 10-50% of patients are lost to follow-up. Current solutions for patient engagement and remote monitoring don’t address the entire problem, and the solutions are fragmented. Despite best efforts, due to complex workflows and intense resource requirements, investigators and research sites remain burdened in a complex ecosystem and often even in the most well designed clinical trials, data can be uninterpretable creating challenges for decision makers in regulatory and in clinical practice. What if there is a solution where qualified healthcare professionals can conduct patient visits anywhere or anytime, perform a comprehensive list of assessments required in clinical trials and deliver the data almost real-time to all stakeholders? What if a system allowed patients from all geographies and demographics to participate in a least burdensome way? What if point in time assessments can be deployed when a late safety signal emerges? How might that affect clinical trial design, timeliness of regulatory reviews and decisions and the overall cost of clinical trials? This session explores a solution and impact of dramatically re-wiring how patients access and are followed in clinical trials.