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RWD Clinical Trials
Explore how RWD clinical trials leveraging approaches such as external control arms, hybrid controls, pragmatic elements, and covariate adjustment are reducing timelines, costs, and patient burdens.
Pragmatic trials
Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Book
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Pragmatic trials
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
Guidance
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Pragmatic trials
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry
Guidance
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Pragmatic trials
Electronic Source Data in Clinical Investigations
Guidance
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Pragmatic trials
Series: Pragmatic Trials and Real World Evidence
Paper Series
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Registry RCTs
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
Guidance
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ECA
Real-world evidence (RWE) to reduce the size and duration of clinical trials
Blog Post
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ECA
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
Guidance
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