Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process—Findings from a qualitative study

T. Guetterman, M. Fetters, Laurie J. Legocki, Samkeliso Mawocha, W. Barsan, R. Lewis, D. Berry, W. Meurer
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引用次数: 11

Abstract

Abstract The context for this study was the Adaptive Designs Advancing Promising Treatments Into Trials (ADAPT-IT) project, which aimed to incorporate flexible adaptive designs into pivotal clinical trials and to conduct an assessment of the trial development process. Little research provides guidance to academic institutions in planning adaptive trials. The purpose of this qualitative study was to explore the perspectives and experiences of stakeholders as they reflected back about the interactive ADAPT-IT adaptive design development process, and to understand their perspectives regarding lessons learned about the design of the trials and trial development. The authors conducted semi-structured interviews with 10 key stakeholders, and observations of the process. They employed qualitative thematic text data analysis to reduce the data into themes about the ADAPT-IT project and adaptive clinical trials. The qualitative analysis revealed four themes: education of the project participants, how the process evolved with participant feedback, procedures that could enhance the development of other trials, and education of the broader research community. While participants became more likely to consider flexible adaptive designs, additional education is needed to both understand the adaptive methodology and articulate it when planning trials.
关于适应性设计加速有希望的治疗试验(ADAPT-IT)过程的思考——一项定性研究的结果
本研究的背景是Adaptive Designs Advancing Promising therapies Into Trials (ADAPT-IT)项目,该项目旨在将灵活的适应性设计纳入关键临床试验,并对试验开发过程进行评估。很少有研究为学术机构规划适应性试验提供指导。本定性研究的目的是探讨利益相关者在反思交互式ADAPT-IT适应性设计开发过程时的观点和经验,并了解他们对试验设计和试验开发的经验教训的看法。作者对10个关键利益相关者进行了半结构化访谈,并对过程进行了观察。他们采用定性主题文本数据分析,将数据简化为ADAPT-IT项目和适应性临床试验的主题。定性分析揭示了四个主题:项目参与者的教育、参与者的反馈如何演变过程、可以促进其他试验发展的程序,以及对更广泛的研究界的教育。虽然参与者更有可能考虑灵活的适应性设计,但需要额外的教育来理解适应性方法并在计划试验时阐明它。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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