CONTEXT:  A significant announcement from ConcertAI as they start a 5-year collaborative research programme with the FDA’s Center for Drug Evaluation and Research (CDER).  The aim of the research is to generate foundational research and methodologies to advance RWE’s potential uses in oncology.  Specifically, researchers will look to use technologies that can aid in developing RWE to define strategies to improve patient clinical treatment outcomes; optimize the design of clinical trials; and inform approaches to RWD-enabled safety assessments.

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1. “The collaboration will utilize ConcertAI’s oncology real-world data (RWD) and advanced AI technology solutions to derive Real-World Evidence (RWE) across a variety of clinical and regulatory use cases. ” 

2. “ConcertAI and the FDA to Collaborate to Advance the Knowledge on the Potential uses of Real-World Evidence. ” 

3. “BOSTON, June 15, 2021 /PRNewswire/ ConcertAI is embarking on a five-year collaborative research program with the U. S. Food and Drug Administration, “Evaluation of Real-World Outcomes and Safety in the Treatment of Cancer. ” ” 

4. “The importance of RWD in the generation of evidence has been accelerating. ” 

5. “The research is also intended to advance technologies that may aid in the management and analyses of RWD. ” 

Source URL: https://www.prnewswire.com/news-releases/concertai-and-the-fda-to-collaborate-to-advance-the-knowledge-on-the-potential-uses-of-real-world-evidence-301312179.html