REAL-WORLD DATA (RWD) / REAL-WORD EVIDENCE (RWE) INSIGHTS
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Embracing Hybrid Trial Design — How, When, & Why To Use It
Global Clinical Sciences & Operations Innovation Lead Lewis Millen talks about UCB’s approach to hybrid trial design, how and when it chooses to implement remote and virtual elements, and why a hybrid trial is beneficial to both the sponsor and the patient.
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Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities
One of the chief benefits of applying RWD for rapid signal assessment is that it can provide a more accurate view of outcomes that should be expected within a given clinical scenario. However, before RWD’s maximum potential for rapid signal assessment can be reached, the industry must overcome some sizable challenges. Amgen's Vaishali Patadia explains.
RWD/RWE RESOURCES
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Choosing An EDC With A Robust API For DTx Clinical Trials
This white paper explores the importance of choosing an EDC with an API before starting a clinical trial.
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Comprehensive Data Management For Non-Interventional Research
Learn how your teams can embrace end-to-end clinical trial data platforms for non-interventional studies to improve user experience, boost patient engagement, ensure data quality, and achieve study success.
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Single-Arm Trials Use Real-World Evidence For Rare Disease Drug Development
In rare disease product development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Gain insight into the regulatory considerations for single-arm trials.
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The Pharmaceutical Industry: 2024 (And Beyond) Predictions
DCTs, RWD, IRA … our industry predictions for 2024 are filled with acronyms. As we delve into 2024, explore what trends are hot ― and not ― for the coming year, and their impact on the industry.
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Solving The Puzzle Of Real-World Data/Evidence
Gain insight from several industry experts on how real-world data can be used to advance clinical research and enhance the landscape of therapeutic product development.
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Real-World Data Vs. Real-World Evidence
Unearth the ways real-world data (RWD) and real-world evidence (RWE) in clinical R&D can be used to provide additional validation for new therapies and drugs regarding their efficacy, safety, and value.
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Real-World Evidence - Where Are We Now?
Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.