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 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...
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 evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting the benefits of treatment interventions. Accelerating this trend is the Food and Drug Administration’s growing understanding of how RWE has helped researchers better understand and use COVID-19 treatments. While placebo-controlled trials continue to have a...
Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical...
In a multilateral paradigm shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late-phase (RWLP) trials. The increasing use of real-world data (RWD) and real-world evidence (RWE) to support clinical development has been informed by recent regulatory guidance and accelerated by the global COVID-19 pandemic. Stakeholders across the spectrum are...
Stacy Weil, Vice President, Clinical Data Operations, Strategic Business Optimization, and Kristi Miller, Ph.D., Vice President, Regulatory Affairs, address the following: Expanded patient enrollment options when using RWDNew strategies for collecting and monitoring patient dataRecent regulatory reforms concerning acceptance of RWDCase studies illustrating the use of RWD for regulatory purposes What’s challenging you today? Fill...
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. The...
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...
Featured Guests Stacy WeilSenior Vice President,Clinical Data Operations, Strategic Business Optimization Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP.Read More Nach Davé,...