CONTEXT: Big news in the world of Big data. When Action, Flatiron Health, IQVIA, Syapse and Tempus all get together to form a coalition with the aim of promoting RWE in regulatory decision making, then we need to sit up and take note. Things just got real in the world of Real-World Data.
IMPACT: High
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 10
1. “The RWE Alliance will collaborate with patient groups, biopharmaceutical and medical device companies and their trade associations, as well as other key stakeholders to support broader efforts around the use of RWE.”
2. “WASHINGTON–(BUSINESS WIRE)–Five real-world data (RWD) and analytics organizations today announced an industry coalition dedicated to advancing the use of real-world evidence (RWE) to support regulatory decisions.”
3. “The RWE Alliance intends to engage with the Food and Drug Administration (FDA) and Congress to advocate for policies that advance the use of RWE in regulatory decision making and benefit patients.”
4. “Congress included policies to advance the use of RWE in the 21st Century Cures Act, and FDA has taken steps to explore the use of RWE for regulatory decision making, including by issuing a framework for the Agency’s RWE Program and by engaging in multiple RWE-focused research collaborations.”
5. ““We applaud FDA’s ongoing leadership in forging the necessary public and private partnership to advance its use of RWE to monitor post-market safety and adverse events and to make regulatory decisions,” said Rob Kotchie, President, Real World Solutions, IQVIA.”