DeVito Nicholas J, Morley Jessica, Goldacre Ben
Nuffield Department of Primary Care Health Science, University of Oxford, Oxford, United Kingdom.
Nuffield Department of Primary Care Health Science, University of Oxford, Oxford, United Kingdom.
Health Policy. 2024 Apr;142:104991. doi: 10.1016/j.healthpol.2024.104991. Epub 2024 Jan 12.
Since 2017, the UK government has made concerted efforts to ensure the dissemination of clinical trials conducted at public research institutions. This study aims to understand how stakeholders within these institutions responded to these pressures and modified internal policies and processes while identifying best practices and barriers to improved transparency practice.
Research governance and trial management staff from UK public research institutions (i.e., Universities and NHS Trusts) in England, Scotland and Wales participated in semi-structured interviews. Interviews were analysed using thematic analysis, aided by the framework method.
Between November 2020 and July 2021, 14 individual participants were recruited from 11 different institutions. They worked in research governance, administration, and management. Almost universally, new policies and procedures have been established to ensure investigators are aware of, and supported in, fulfilling their transparency commitments, however challenges remain. Trials of medicinal products, as the most closely regulated research, consequently received the most attention. National professional networks aid in sharing knowledge and best practice within this community.
Investment in the institutional governance of transparency is essential to achieving optimal transparency practices. Universities and hospitals share responsibility for ensuring research is performed and reported to regulatory standards. Facing political pressure, public research institutions in the UK have made efforts to improve their transparency practice which can provide key insights for similar efforts elsewhere.
自2017年以来，英国政府齐心协力确保在公共研究机构开展的临床试验得到传播。本研究旨在了解这些机构内的利益相关者如何应对这些压力，以及如何修改内部政策和流程，同时确定提高透明度实践的最佳做法和障碍。
来自英格兰、苏格兰和威尔士的英国公共研究机构（即大学和国民保健服务信托基金）的研究治理和试验管理人员参与了半结构化访谈。采用主题分析法并借助框架法对访谈进行分析。
在2020年11月至2021年7月期间，从11个不同机构招募了14名个体参与者。他们从事研究治理、行政和管理工作。几乎普遍都制定了新的政策和程序，以确保研究人员了解并得到支持来履行其透明度承诺，然而挑战依然存在。作为监管最严格的研究类型，药品试验因此受到了最多关注。国家专业网络有助于在这个群体中分享知识和最佳实践。
对透明度的机构治理进行投资对于实现最佳透明度实践至关重要。大学和医院共同负责确保研究按照监管标准进行和报告。面对政治压力，英国的公共研究机构已努力改进其透明度实践，这可为其他地方的类似努力提供关键见解。
