Tag: real-world evidence 7 results

Real-World & Late Phase

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…

Real-World & Late Phase

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 is…

Real-World & Late Phase

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…

Real-World & Late Phase

Entering a New Clinical Phase of Non-Traditional Data Sources

This is part two of a two-part series, 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. The rise of real-world data and real-world evidence Non-traditional data points, in particular real-world data (RWD)…

Rare Disease

Premier Presentations from WODC

Watch Premier Research’s presentations from World Orphan Drug Congress 2020 below. Note: You must be logged into your WODC Swapcard account to view presentations Rare Disease Recruitment: Addressing Enrollment Hurdles and Differentiating Your Clinical Trial in an Increasingly Competitive Research Environment Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease & Pediatrics, shares tips for overcoming…

Real-World & Late Phase

Can Your Clinical Data Strategy Keep Pace?

Here we cover the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face of a changing clinical research environment.