R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11
Publication: Journal of Comparative Effectiveness Research
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.
Formats available
You can view the full content in the following formats:
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
Information & Authors
Information
Published In
Copyright
© 2023 The Authors. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 9 March 2022
Accepted: 9 March 2023
Published online: 13 April 2023
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11. (2023) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2023-0008
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Paul Arora, Sreeram V Ramagopalan, R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 25, Journal of Comparative Effectiveness Research, 10.57264/cer-2026-0073, 15, 6, (2026).
- Paul Arora, Sreeram V Ramagopalan, R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 21, Journal of Comparative Effectiveness Research, 10.57264/cer-2025-0148, 14, 11, (2025).
- Paul Arora, Sreeram V Ramagopalan, R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 19, Journal of Comparative Effectiveness Research, 10.57264/cer-2025-0063, 14, 7, (2025).
- Paul Arora, Sreeram V Ramagopalan, R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 17, Journal of Comparative Effectiveness Research, 10.57264/cer-2024-0212, 14, 1, (2024).
- Alejandra Castanon, Antonia Tsvetanova, Sreeram V Ramagopalan, RWE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 16, Journal of Comparative Effectiveness Research, 10.57264/cer-2024-0095, 13, 8, (2024).
- Benjamin D Bray, Sreeram V Ramagopalan, R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 13, Journal of Comparative Effectiveness Research, 10.57264/cer-2023-0141, 12, 11, (2023).
- Ben Bray, Sreeram V Ramagopalan, R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 12, Journal of Comparative Effectiveness Research, 10.57264/cer-2023-0092, 12, 7, (2023).
