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Published in 2022 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2565
Abstract: Real-world data (RWD) and real-world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the health care ecosystem to evaluate medical products…
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Keywords:
support;
decision;
decision making;
regulatory decision ... See more keywords
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Published in 2022 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2022.01.012
Abstract: PURPOSE Interest in leveraging real-world evidence (RWE) to support regulatory decision making for product effectiveness has been increasing globally as evident by the increasing number of regulatory frameworks and guidance documents. However, acceptance of RWE,…
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Keywords:
world;
decision making;
regulatory decision;
guidance ... See more keywords
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Published in 2021 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2021.669509
Abstract: Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and…
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Keywords:
real world;
rwe;
regulatory decision;
world ... See more keywords
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Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.869262
Abstract: Regulatory decisions for new drugs approval present high uncertainty, low reversibility, the avoidance of observable errors, and high political stakes. However, research on the behavior of regulatory agencies is scarce, particularly in the context of…
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Keywords:
new drugs;
viewpoints manufacturers;
regulatory decision;
perceptions regulatory ... See more keywords
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Published in 2022 at "Frontiers in Pharmacology"
DOI: 10.3389/fphar.2022.928121
Abstract: Aims: In countries where a randomized clinical trial (RCT) is difficult to perform, a real-world evidence (RWE) study with a design similar to an RCT may be an option for drug regulatory decision-making. In this…
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Keywords:
safety;
world data;
regulatory decision;
rct ... See more keywords