How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis

Flight, L., Julious, S., Brennan, A., Todd, S. T. ORCID: https://orcid.org/0000-0002-9981-923X and Hind, D. (2020) How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis. Trials, 21. 252. ISSN 1745-6215 doi: 10.1186/s13063-020-4137-2

Abstract/Summary

Introduction Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite research budgets and accurate decision-making are priorities for healthcare providers around the world. The methods of health economics, which aim to maximise the health gained for money spent, could be incorporated into the design and analysis of adaptive clinical trials to make them more efficient. We aimed to understand the perspectives of stakeholders in health technology assessments to inform recommendations for the use of health economics in adaptive clinical trials. Methods A qualitative study explored the attitudes of key stakeholders—including researchers, decision-makers and members of the public—towards the use of health economics in the design and analysis of adaptive clinical trials. Data were collected using interviews and focus groups (29 participants). A framework analysis was used to identify themes in the transcripts. Results It was considered that answering the clinical research question should be the priority in a clinical trial, notwithstanding the importance of cost-effectiveness for decision-making. Concerns raised by participants included handling the volatile nature of cost data at interim analyses; implementing this approach in global trials; resourcing adaptive trials which are designed and adapted based on health economic outcomes; and training stakeholders in these methods so that they can be implemented and appropriately interpreted. Conclusion The use of health economics in the design and analysis of adaptive clinical trials has the potential to increase the efficiency of health technology assessments worldwide. Recommendations are made concerning the development of methods allowing the use of health economics in adaptive clinical trials, and suggestions are given to facilitate their implementation in practice.

Item Type	Article
URI	https://reading-clone.eprints-hosting.org/id/eprint/88940
Identification Number/DOI	10.1186/s13063-020-4137-2
Refereed	Yes
Divisions	Science > School of Mathematical, Physical and Computational Sciences > Department of Mathematics and Statistics Science > School of Mathematical, Physical and Computational Sciences > Department of Mathematics and Statistics > Applied Statistics
Publisher	Springer
Download/View statistics	View download statistics for this item