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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SMART On FHIR: Auto-Populate eCRFs On Study Day 1
Get an overview of SMART on Fast Healthcare Interoperability (FHIR) for clinical trials, including workflow improvements, real-world data (RWD) integration, and reducing researcher burnout.
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The Future Of Health Data: A 2022 Life Sciences Industry Insights Report
A survey of life sciences leaders reveals some of the key challenges that come with using real-world data (RWD) for innovation, along with their vision and predictions for how RWD can accelerate drug development and improve patient outcomes.
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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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Patient Diversity Case Study: RWD Solutions
A clinical trial sponsor, lagging in recruitment of Hispanic and Asian patients, was looking to diversify participants for its NASH study. See how by leveraging medical claims and diversity data, the sponsor identified relevant patients meeting the trial’s I/E criteria, broken out by race and gender.
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Could ePRO Be The New Standard In Health Reimbursement?
Recently, early-phase protocols have been collecting patient-reported outcomes (PROs) not only to get regulatory approval but to demonstrate value to public and private payers.
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5 Patient Engagement & Recruitment Trends, And How To Keep Up With Them
From decentralized trials to real world data, take a look at top trends, their impact on patient enrollment and more, as well as ways to stay ahead of the curve.
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One Day, We Won’t Need Placebos
Embrace the future of clinical research by recognizing the limitations of traditional double-blind trials and exploring the transformative potential of real-world evidence (RWE).