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.

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如何在适应性临床试验的设计和分析中使用健康经济学？定性分析。

简介自适应设计提供了一种灵活的方法，允许根据数据进行过程中的检查来更改试验。适应性临床试验正成为一种流行的选择，因为谨慎使用有限的研究预算和准确的决策是全球医疗保健提供者的优先事项。旨在最大化花钱所能获得的健康的健康经济学方法，可以纳入适应性临床试验的设计和分析中，以提高其效率。我们旨在了解健康技术评估中利益相关者的观点，以为在适应性临床试验中使用健康经济学提供建议。方法定性研究探索了关键利益相关者的态度，包括研究人员，决策者和公众-运用健康经济学设计和分析适应性临床试验。使用访谈和焦点小组（29名参与者）收集数据。框架分析用于识别成绩单中的主题。结果有人认为，尽管成本效益对决策至关重要，但回答临床研究问题应是临床试验中的优先事项。与会者提出的关切包括在临时分析中处理成本数据的易变性。在全球试验中实施这种方法；为适应性试验提供资源，这些试验是根据卫生经济成果进行设计和调整的；并对利益相关者进行这些方法的培训，以便可以实施和适当解释它们。结论在适应性临床试验的设计和分析中使用卫生经济学有可能提高全世界卫生技术评估的效率。就发展允许在适应性临床试验中使用卫生经济学的方法提出了建议，并提出了一些建议以促进其在实践中的实施。