Flight, L. orcid.org/0000-0002-9569-8290, Arshad, F., Barnsley, R. et al. (4 more authors) (2019) A review of clinical trials with an adaptive design and health economic analysis. Value in Health, 22 (4). pp. 391-398. ISSN 1098-3015
Abstract
Objective An adaptive design uses data collected as a clinical trial progresses to inform modifications to the trial. Hence, adaptive designs and health economics aim to facilitate efficient and accurate decision making. Nevertheless, it is unclear whether the methods are considered together in the design, analysis, and reporting of trials. This review aims to establish how health economic outcomes are used in the design, analysis, and reporting of adaptive designs.
Methods Registered and published trials up to August 2016 with an adaptive design and health economic analysis were identified. The use of health economics in the design, analysis, and reporting was assessed. Summary statistics are presented and recommendations formed based on the research team's experiences and a practical interpretation of the results.
Results Thirty-seven trials with an adaptive design and health economic analysis were identified. It was not clear whether the health economic analysis accounted for the adaptive design in 17/37 trials where this was thought necessary, nor whether health economic outcomes were used at the interim analysis for 18/19 of trials with results. The reporting of health economic results was suboptimal for the (17/19) trials with published results.
Conclusions Appropriate consideration is rarely given to the health economic analysis of adaptive designs. Opportunities to use health economic outcomes in the design and analysis of adaptive trials are being missed. Further work is needed to establish whether adaptive designs and health economic analyses can be used together to increase the efficiency of health technology assessments without compromising accuracy.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018 ISPOR - The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
Keywords: | adaptive design; cost-effectivenes; clinical trials; value of information |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Funding Information: | Funder Grant number NATIONAL INSTITUTE FOR HEALTH RESEARCH DRF-2015-08-013 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 18 Dec 2018 10:19 |
Last Modified: | 24 Nov 2021 11:39 |
Status: | Published |
Publisher: | Elsevier |
Refereed: | Yes |
Identification Number: | 10.1016/j.jval.2018.11.008 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:140137 |