FDA see expanded role for real-world evidence (RWE); Merck KGaA and Pfizer generate RWE for regulatory submission

RWE has the potential to both accelerate approval timelines and reduce the costs of drug development RWE studies must uphold established standards of evidence – including standards for Good Clinical Practice (GCP) and 21 CFR Part 11 requirements Concerns around the reliability of real-world data collection and data gaps limit the potential value of RWE…

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Synapse and FDA collaborate to swiftly generate real-world data (RWD) in COVID-19 patients with cancer

The collaboration is already yielding useful results and aims to tackle the following: Investigating methods to derive RWD from multiple sources including electronic health records, registries and molecular data Enhancing understanding of how patients respond to therapies outside of clinical trials to improve care and outcomes Understanding the impact of COVID-19 on cancer care Click here to learn more…

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Real-world evidence supports CAR-T-cell therapy’s safety and efficacy

A retrospective study in 275 (treated) patients with relapsed or refractory large B-cell lymphoma found (Yescarta) axicabtagene ciloleucel gave similar responses to those seen in clinical trials This evidence is valuable in supporting the clinical trial results; because “The issue with clinical trials is that they often are very highly selective,” – Michael D. Jain, MD,…

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NICE and Flatiron partner to utilise real-world oncology data in informing decisions about cancer therapy access

Flatiron Health have been partnered with the FDA in the US since 2016, with whom they have explored real-world outcomes and alternative study methods Experts from both NICE and Flatiron Health will conduct research using Flatiron’s electronic health record (EHR)-derived database “We are excited to explore how real-world evidence could be incorporated into our work…

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