Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including simplifying the ethics review and governance process of clinical trials. This study’s objective was to systematically review the effects of government actions targeting ethics reviews or governance processes on clinical trial activity. The data sources of Pub Med, Scopus, Sage, ProQuest, Google, Google Scholar and reference lists were all searched between 9/8/20 and 6/9/20. From these sources, 1455 potentially eligible reports were reviewed and full text assessments were done for 295. Thirty-eight reports provided data on 45 interventions—13 targeting ethics review and 32 targeting governance processes—were included. There were data describing effects on a primary or secondary outcome (the number of clinical trials or expenditure on clinical trials) for 39/45 of the interventions. 23/39 (59%) reported positive effects, meaning a greater number of trials and/or expenditure on clinical trials (6/11 ethics, 17/28 governance), 7/39 (18%) reported null effects (4/11 ethics, 3/28 governance) and 9/39 (23%) reported adverse effects (1/13 ethics, 8/28 governance). Positive effects were attributable to interventions that better defined the scope of review, placed clear expectations on timelines or sought to achieve mutual acceptance of ethics review outcomes. Adverse effects were mostly caused by governance interventions that unintentionally added an extra layer of bureaucracy or were developed without full consideration of the broader clinical trial approval system. Governments have an opportunity to enhance clinical trial activity with interventions targeting ethics reviews and governance processes but must be aware that some interventions can have an adverse impact.

政府已尝试使用一系列方法增加其管辖范围内的临床试验活动，包括简化临床试验的伦理审查和治理过程。本研究的目的是系统地审查针对伦理审查或治理过程的政府行动对临床试验活动的影响。Pub Med、Scopus、Sage、ProQuest、Google、Google Scholar 和参考文献列表的数据源均在 2020 年 9 月 8 日至 2020 年 6 月 9 日之间进行了搜索。从这些来源中，审查了 1455 份可能符合条件的报告，并对 295 份进行了全文评估。包括 38 份报告提供了 45 项干预措施的数据——13 项针对伦理审查，32 项针对治理流程。有数据描述了 39/45 干预措施对主要或次要结果（临床试验数量或临床试验支出）的影响。23/39 (5​​9%) 报告了积极影响，这意味着更多的试验和/或临床试验支出（6/11 伦理，17/28 治理），7/39 (18%) 报告无效影响 (4/11道德，3/28 治理）和 9/39（23%）报告了不利影响（1/13 道德，8/28 治理）。积极影响归因于干预措施更好地定义了审查范围，对时间表提出了明确的期望或寻求实现伦理审查结果的相互接受。不利影响主要是由于治理干预措施无意中增加了额外的官僚机构，或者是在没有充分考虑更广泛的临床试验批准系统的情况下制定的。