Article | May 15, 2023

Unlocking The Power Of Real-World Evidence In FDA Submissions

Source: Castor
GettyImages-182487080 FDA

Real-world evidence (RWE) has become a significant focus for the FDA and those involved in FDA submissions, and its importance continues to grow. Since the enactment of the Cures Act in 2016, the FDA has actively sought opportunities to leverage real-world data (RWD) and has recognized the significance of RWE. As a result, RWE in regulatory submissions for new products has become increasingly imperative.

RWD is gradually gaining prominence on par with randomized clinical trials (RCTs), which have long been considered the gold standard for generating conclusive evidence. While RCTs are meticulously structured and conducted to meet rigorous clinical criteria, RWD, on the other hand, primarily gathers data to support purposes beyond clinical trials, and historically has often been given less consideration in supporting clinical trials.

However, as data availability continues to grow, it’s become inevitable that the robustness and methodologies inherent in RCTs would be integrated into the ever-increasing volume of RWD being generated daily. Understand the gaps between how data is collected in RWE and RCT, and how RWE is quickly finding ways to catch up: from applying rigor to RWE by reusing data models and repurposing methodologies from RCTS to creating fit-for-purpose methodologies for postmarket surveillance.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Tech Leader? Subscribe today.

Subscribe to Clinical Tech Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Tech Leader