The Use of Real-World Data and Evidence in Clinical Trials
The use of real-world data and evidence in clinical trials is increasing, with applications in trial design, recruitment, and regulatory decisions. A study by Tufts CSDD and Verana Health found that oncology has the most mature adoption of real-world data, with uses including informing inclusion/exclusion criteria and supporting accelerated approvals.
Real-world data is being used to optimize clinical trial design and reduce recruitment burden. The FDA defines real-world data as data relating to patient health status and/or healthcare delivery, collected from sources like electronic health records and patient registries. A study examined the use of real-world data and evidence in clinical trials across five therapeutic areas. The study found that real-world data can enhance clinical research efficiency and facilitate faster accrual. Despite advantages, industry stakeholders and regulatory authorities are cautious due to concerns about reliability. The study identified challenges around data quality, integration, and internal alignment.
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