A lot has been written about the promise of real-world data (RWD) in life sciences, but quite often, one key question is left unanswered: “How does it actually work?”
Recent advances in healthcare data access, technology, and regulatory guidance have created an opportunity for the biopharmaceutical industry to use RWD in clinical research to accelerate the pace of innovation in drug development. Leading life science companies are exploring ways to design hybrid trials, use RWD to complete retrospective studies on sub-cohorts of patients, and to conduct long-term safety and surveillance monitoring.
Parexel recently teamed up with our partners at Datavant and Precisions Digital Health to design and conduct a proof-of-concept study that would demonstrate the operational feasibility of a trial that incorporates RWD. Specifically, we wanted to show that we could:
- Use multiple disparate data types: Incorporate data beyond the electronic data capture system used in clinical trials, including patient-reported outcomes and wearables data.
- Protect patient privacy: Connect record-level data from multiple systems while protecting patient privacy.
- Support scientific inference: Ensure the data was gathered and connected in a way that could support scientific inferences in appropriately powered studies.
Data has utility beyond the completion of a study to answer many clinical and commercial questions. With our operational feasibility study, we achieve an integrated view of the patient journey that can extend post-endpoint collection.
Read our full whitepaper to learn more.