Article | September 29, 2020

Entering A New Clinical Phase of Non-Traditional Data Sources

By Nach Dave & Stacy Weil

epro mobile health techonolgy

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.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: