Real-World Data Enhanced Clinical Trial Design

By Dan O'Connor, SVP of Growth, Ciox Real World Data

The challenges associated with executing successful clinical trials are well documented and increasing.  This reality prevents promising treatments from reaching patients faster. However, clinical research is evolving. The industry is seeing an unprecedented opportunity to improve the pace of new therapies to patients—especially those with life-threatening conditions—through novel applications of real-world data.

With expanding support from the FDA, the use of routinely collected clinical data at the point of care—Real-World Data—is becoming a promising tool for research teams. As regulators approve more therapies via accelerated pathways and novel trial designs e.g., single arm studies, post-approval study commitments are becoming more important than ever.  Sponsors and regulators must understand how these products work outside the tightly designed settings of the clinical trial, in the real-world. 

The interest in real-world data has skyrocketed but knowing when and how to use has been an adoption hurdle for the industry. There are three use cases particularly appropriate for real-world data: synthetic or external comparators (SCA/ECA) to replace or augment standard controls; precision registries for adaptive trial design; and clinical trial site feasibility to improve patient enrollment and recruitment.