Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
- Published: 01 September 2022
- Posted: 09 September 2022
To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE.
Topics: Real-World Evidence
- Published: 23 May 2022
- Posted: 08 September 2022
As the need for a more rapid and efficient means of rigorous clinical evidence generated about medical products from diverse practice settings increases, so has interest in point-of-care (POC) clinical trials. Yet, although interest in and technical capabilities to support POC trials continues to rise, actual implementation of scaled, impactful POC platforms remains limited. The Duke-Margolis Real-World Evidence (RWE) Collaborative Point-of-Care Trials Working Group outlines steps to enable point-of-care trials to achieve their potential.
Topics: Clinical Trials, Real-World Evidence
- Published: 06 May 2022
- Posted: 07 July 2022
Abstract: Real-world evidence (RWE) increasingly informs public health and healthcare decisions worldwide. A large database has been created (“Integrated Dataset”) that integrates primary care electronic medical records with pharmacy and medical claims data on >123 million US patients since 2014. This article describes the components of the Integrated Dataset and evaluates its represen- tativeness to the US population and its potential use in evaluating influenza vaccine effectiveness.
Topics: Real-World Evidence, Health Data Analytics