Tag: RWE

Clinical Research: Phase 1 - Phase 4

Leveraging Real-World Data & Real-World Evidence to Support Regulatory Decision Making

The FDA is committed to increasing sponsor opportunities to apply RWD and RWE to support regulatory decision-making.1 The goal is to use quantities of available data, streamline the drug development process, and learn how interventions perform in real-world use, outside the strictly controlled limits of a clinical trial. According to legal and scientific standards, the...

Clinical Research: Phase 1 - Phase 4

A Fit-for-Purpose Path Forward: Linking RWD to Your Overall Data Strategy

Real-world data (RWD) and real-world evidence (RWE) have become an increasingly important part of the medical product development landscape. These tools can enable sponsors to optimize clinical trial designs and demonstrate the real-world effectiveness of new medical products. Part 2 of this three-part blog series outlines a fit-for-purpose approach to RWE. (See Part 1:  What...

Clinical Research: Phase 1 - Phase 4

What is Real-World Data and Evidence and How It Can Facilitate Clinical Development

The 21st Century Cures Act (Cures Act)1 signed into United States law in 2016 aims to accelerate medical product development and bring innovations to patients faster through real-world evidence (RWE) to support regulatory decision making. Incorporating real-world data (RWD) and real-world evidence (RWE) can help pharma and biotech companies optimize clinical trial designs and demonstrate...