UK Explains How To Plan For Randomized Trials Using Mainly RWD Sources
Guideline Does Not Cover Clinical Trials Using RWD As A Control Arm
The UK Medicines and Healthcare products Regulatory Agency has finalized the first part of a series of new guidance documents addressing issues around using real-world data in support of regulatory submissions.
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A senior GCP inspector examines the factors that sponsors should consider when deciding on the suitability of using real-world data in clinical studies.
The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.
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