The current landscape and emerging applications for real-world data in diagnostics and clinical decision support and its impact on regulatory decision making.
Sign Up to like & getrecommendations! 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… read more here.
Keywords: support; decision; decision making; regulatory decision ... See more keywords
Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World.
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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,… read more here.
Keywords: world; decision making; regulatory decision; guidance ... See more keywords
From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments
Sign Up to like & getrecommendations! Published in 2024 at "Drug Design, Development and Therapy"
DOI: 10.2147/dddt.s490289
Abstract: Abstract In recent years, patient-focused drug development (PFDD) has received widespread attention as a new paradigm in clinical trials. The PFDD emphasizes patients are partners in research projects, where patients can participate in research design,… read more here.
Keywords: patient reported; reported outcome; decision making; drug ... See more keywords
Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model
Sign Up to like & getrecommendations! 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… read more here.
Keywords: real world; rwe; regulatory decision; world ... See more keywords
Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea
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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… read more here.
Keywords: new drugs; viewpoints manufacturers; regulatory decision; perceptions regulatory ... See more keywords
Using real-world data for supporting regulatory decision making: Comparison of cardiovascular and safety outcomes of an empagliflozin randomized clinical trial versus real-world data
Sign Up to like & getrecommendations! 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… read more here.
Keywords: safety; world data; regulatory decision; rct ... See more keywords