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Pharmacy China 2023 Paper BR170Application of real world data in clinical trial site selection and improving patient
recruitment
Sindhi Zhou, Taiping Yang, Die Liu, Xiaojuan Zhang, BeiGe ne (Beijing)
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What is application of real-world data?
Real-world data application refers to the use of data collected outside of traditional clinical trials to inform decision-making in healthcare, including drug development, regulatory approvals, and post-market safety monitoring.
Who is required to file application of real-world data?
Typically, pharmaceutical companies, healthcare researchers, and other organizations involved in drug development and post-market surveillance are required to file applications of real-world data.
How to fill out application of real-world data?
To fill out the application, one must gather necessary data, complete the required forms with accurate information, ensure compliance with regulatory guidelines, and submit the application through the designated electronic submission portal.
What is the purpose of application of real-world data?
The purpose is to enhance the understanding of a drug's efficacy and safety in the general population, support regulatory decisions, and ensure optimal patient outcomes.
What information must be reported on application of real-world data?
Information that must be reported includes data sources, study design, patient demographics, treatment patterns, outcomes, and any potential biases or limitations in the data.
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