R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11.

Journal of comparative effectiveness research（2023）

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摘要

In this latest update we highlight a study from the REPEAT initiative that evaluates the reproducibility of real-world data studies, the publication of the HARPER Protocol Template developed by a joint ISPE/ISPOR taskforce, and discuss recent US FDA guidance on external control arms.

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FDA,HARPER,REPEAT,RWD,external control arms,protocols,real-world data,reproducibility,trial design

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