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Industry Update
13 April 2023

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

Abstract

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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References

1.
Wang SV, Sreedhara SK, Schneeweiss S. REPEAT Initiative. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nat. Commun. 13(1), 5126 (2022).
2.
Wang SV, Pottegård A, Crown W et al. HARmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol. Drug Saf. 32, 44–55 (2023).
3.
Wang SV, Pinheiro S, Hua W et al. STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies. Br. Med. J. 372, m4856 (2021).
4.
Center for Drug Evaluation and Research. Considerations for the design and conduct of externally controlled trials for drug and biological products. US Food and Drug Administration (2023). www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products
5.
NICE real-world evidence framework: overview. Real-world Evidence Framework (2022). www.nice.org.uk/corporate/ecd9/chapter/overview