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Pragmatic trials
Pragmatic trials leveraging routinely captured data in typical care settings significantly reduce operational costs, increase speed, and enhance the generalizability of findings.
Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Book
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
Guidance
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry
Guidance
Electronic Source Data in Clinical Investigations
Guidance
Series: Pragmatic Trials and Real World Evidence
Paper Series
Real-world evidence (RWE) to reduce the size and duration of clinical trials
Blog Post