R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11-Reference-Cited by-同舟云学术

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

Published:2023-05 Issue:5 Volume:12 Page:
ISSN:2042-6305
Container-title:Journal of Comparative Effectiveness Research
language:en
Short-container-title:J. Comp. Eff. Res.

Author:

Bray Ben¹²,Ramagopalan Sreeram V³

Affiliation:

1. Health Analytics, Lane Clark & Peacock, London, W1U 1DQ, UK

2. Department of Population Health Sciences, King’s College London, SE1 9NH, UK

3. Centre for Pharmaceutical Medicine Research, King’s College London, SE1 1UL, UK

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.

Publisher

Becaris Publishing Limited

Subject

Health Policy

Link

https://becarispublishing.com/doi/pdf/10.57264/cer-2023-0008

Reference5 articles.

1. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions;Wang SV;Nat. Commun.,2022

2. 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;Wang SV;Pharmacoepidemiol. Drug Saf.,2023

3. STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies;Wang SV;Br. Med. J.,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

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1. 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;2024-08

2. 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;2023-11

3. 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;2023-07