Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project.
Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project.
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DOI：
10.1186/s13063-021-05022-0
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发表时间：
2021-01-19
期刊：
影响因子：
2.5
通讯作者：
Day S
中科院分区：
文献类型：
--
作者：
Totton N;Julious S;Hughes D;Cook J;Biggs K;Coates L;Cook A;Hewitt C;Day S
根据所研究的治疗，临床试验可以设计为评估优势、等效或非劣效性的目标。研究的设计受到许多不同因素的影响，包括对照治疗、主要结局和相关关系。在一些研究中，可能有不止一个感兴趣的结果。在这些情况下，可以使用收益-风险方法同时评估结果，并考虑治疗的收益与风险之间的权衡。收益风险在监管行业中使用，但很少包括在英国公共资助的临床试验中。该项目旨在就如何选择合适的试验设计（例如优势）以及何时考虑纳入收益-风险方法获得专家共识。一项基于网络的调查以获取当前的经验和意见，一项快速的文献综述以评估任何当前的建议，一项为期两天的共识研讨会以就建议达成一致，以及一份指导文件的制作。该项目将包括四个工作包：项目的目的是为临床研究人员、资助机构和资助机构的审稿人提供指导，指导他们如何选择最合适的试验设计，以及何时考虑使用利益-风险方法。该指南的重点将放在公共资助的试验上，然而，其愿景是这项工作将适用于各种研究环境，我们将酌情与其他组织和委员会联系。
Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elements including the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off between the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods. A web-based survey to elicit current experiences and opinions, A rapid literature review to assess any current recommendations, A two-day consensus workshop to gain agreement on the recommendations, and Production of a guidance document. The project will consist of four work packages: The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.