Department of Health Policy, The London School of Economics and Political Science, London, UK
Consilium Scientific, London, UK.
BMJ Evid Based Med. 2024 Mar 21;29(2):79-86. doi: 10.1136/bmjebm-2023-112395.
To assess to what extent the clinical trial policies of the largest public and philanthropic funders of clinical research in the United States meet WHO best practices in trial registration and reporting.
Public and philanthropic funders of clinical trials in the USA with >US$50 million annual spend were selected. The funders were assessed using an 11-item scoring tool based on WHO Joint Statement benchmarks. These 11 items fell into 4 categories, namely: trial registration, academic publication, monitoring and sanctions. An additional item captured whether and how funders referred to Consolidated Standards of Reporting Trials (CONSORT) within their trial policies. Each funder was independently assessed by two or three researchers. Funders were contacted to flag possible errors and omissions. Ambiguous or difficult-to-score items were settled by an independent adjudicator.
Fourteen funders were assessed. Our cross-sectional study found that, on average, funders have only implemented 4.1/11 (37%) of WHO best practices in clinical trial transparency. The most frequently adopted requirement was open access publishing (14/14 funders). The least frequently adopted were (1) requiring trial ID to appear in all publications (2/14 funders, 14%) and (2) making compliance reports public (2/14 funders, 14%). Public funders, on average, adopted more policy elements (5.2/11 items, 47%) than philanthropic funders (2.8/11 items, 25%). Only one funder's policy documents mentioned the CONSORT statement.
There is a significant variation between the number of best practice policy items adopted by medical research funders in the USA. Many funders fell significantly short of WHO Joint Statement benchmarks. Each funder could benefit from policy revision and strengthening.
评估美国最大的公共和慈善临床研究资助者的临床试验政策在多大程度上符合世界卫生组织（WHO）在临床试验注册和报告方面的最佳实践。
选择了美国每年花费超过 5000 万美元的临床试验公共和慈善资助者。使用基于世界卫生组织联合声明基准的 11 项评分工具对资助者进行评估。这 11 项分为 4 类，即：试验注册、学术出版物、监测和制裁。还有一个项目记录了资助者是否以及如何在其试验政策中提及临床试验报告标准（CONSORT）。每位资助者都由两到三位研究人员独立评估。资助者被联系以标记可能的错误和遗漏。有歧义或难以评分的项目由独立裁判解决。
评估了 14 家资助者。我们的横断面研究发现，平均而言，资助者仅实施了 11 项世界卫生组织临床试验透明度最佳实践中的 4.1 项（37%）。采用最多的要求是开放获取出版（14/14 家资助者）。采用最少的是（1）要求试验 ID 出现在所有出版物中（2/14 家资助者，14%）和（2）公开合规报告（2/14 家资助者，14%）。公共资助者平均采用了更多的政策要素（11 项中的 5.2 项，47%），而慈善资助者采用了较少的政策要素（11 项中的 2.8 项，25%）。只有一家资助者的政策文件提到了 CONSORT 声明。
美国医学研究资助者采用的最佳实践政策项目数量存在显著差异。许多资助者明显低于世界卫生组织联合声明基准。每个资助者都可以从政策修订和加强中受益。
