New approaches to clinical research that harness diverse sources of “real-world data” (RWD) could accelerate the pace of clinical trials, reduce costs, and provide new insights into patient experiences. Keeping at the forefront of this movement, CTTI today announced a new Real-World Evidence Project that is designed to foster greater awareness of these data sources and explore effective ways to leverage them for clinical trials.
Unlike conventional clinical trial data gathered using specialized, costly, and complex systems, RWD is captured from existing sources such as electronic health records (EHRs), billing and insurance claims databases, disease registries, patient generated data, and even mobile devices. When combined and analyzed, these data can yield “real-world evidence” (RWE) that may provide a more accurate and complete picture of patient outcomes and experiences.
However, despite this potential, there have been relatively few attempts to incorporate RWE into trials intended to support regulatory decision making for new medical products and labeling indications—in part because stakeholders have not yet agreed on valid and effective approaches.
CTTI’s RWE work is helping to meet these challenges by:
- Describing how these sources of data can be leveraged to plan and conduct trials;
- Identifying and addressing barriers to such use
- Identifying when RWD/RWE usage may be impractical or unwise; and
- Developing practical approaches to embedding RWE in clinical research.
Ultimately, broad adoption of RWE for regulatory trials may benefit patients and other stakeholders by efficiently creating high-quality, reliable evidence about the safety and effectiveness of medical products.
