Entering A New Clinical Phase of Non-Traditional Data Sources

By Nach Dave & Stacy Weil

The rise of real-world data and real-world evidence

Non-traditional data points, in particular real-world data (RWD) and real-world evidence (RWE), are becoming more and more important in the current research climate. RWD is unstructured data relating to patient health status and/or health care delivery that is routinely collected from a variety of sources, including wearable consumer data, disease registries, and electronic medical records. RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.

Harnessing all of those unstructured pieces of data allows an organization to make regulatory or reimbursement decisions, develop clinical guidelines for how a disease should be treated, and look at how a certain population is trending on a medication or a medical device. This is where the impact and the power of unstructured RWD translates into RWE.

The FDA and other regulators have started to embrace the use of real-world, unstructured data alongside traditional RCT data. This allows sponsors to present a data set that is more conclusive and representative of the patients being studied. Combining unstructured data with structured data offers several advantages.

This is part two of a two-part series based on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment. You can read part one here. In this post, we will cover non-traditional data points, their use in randomized control trials (RCTs), and how they contribute to a successful data strategy.