Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands; Institute of Tropical Medicine, German Centre for Infection Research (DZIF), University of Tübingen, Tübingen, Germany; Centre de Recherches Médicales en Lambaréné (CERMEL), Lambaréné, Gabon; Masanga Medical Research Unit (MMRU), Masanga, Sierra Leone; Institute of Infectious Diseases and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa.
Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands.
Lancet Infect Dis. 2024 Mar;24(3):e189-e195. doi: 10.1016/S1473-3099(23)00455-3. Epub 2023 Oct 11.
Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in registries within 12 months of study completion and published in full text within 24 months. However, only a limited number of clinical trials in infectious diseases, including those done during the COVID-19 pandemic, have their results posted on ClinicalTrials.gov. An analysis of 50 trials of eight antiviral drugs tested against COVID-19 with a completion date of at least 2 years ago revealed that only 18% had their results published in the registry, with 40% not publishing any results. Non-timely and non-reporting practices undermine patient participation and are ethically unacceptable. Strategies should include obligatory reporting of summary results within 12 months in clinical trial registries, with progress towards peer-reviewed publication within 24 months indicated. Timely publication of research papers should be encouraged through an automated flagging mechanism in clinical trial registries that draws attention to the status of results reporting, such as a green tick for trials that have reported summary results within 12 months and a red tick in case of failure to do so. We propose the inclusion of mandatory clinical trial reporting standards in the International Conference on Harmonization Good Clinical Practice guidelines, which should prohibit sponsor contract clauses that restrict reporting (referred to as gag clauses) and require timely reporting of results as part of the ethics committees' clearance process for clinical trial protocols.
不及时报告、选择性报告或不报告临床试验结果是普遍存在且严重的问题。世界卫生组织要求在研究完成后 12 个月内在注册机构中提供摘要结果，并在 24 个月内全文发表。然而，只有有限数量的传染病临床试验，包括在 COVID-19 大流行期间进行的临床试验，其结果在 ClinicalTrials.gov 上公布。对 50 项针对 COVID-19 的八种抗病毒药物的试验进行分析，这些试验的完成日期至少在 2 年前，结果显示只有 18%的试验在注册机构中公布了结果，40%的试验没有公布任何结果。不及时和不报告的做法破坏了患者的参与，在道德上是不可接受的。策略应包括在临床试验注册机构中强制性地在 12 个月内报告摘要结果，并在 24 个月内表明向同行评审发表的进展。应通过临床试验注册机构中的自动标记机制鼓励及时发表研究论文，该机制提请注意结果报告的状态，例如对在 12 个月内报告摘要结果的试验打勾绿色标记，对未能报告的试验打勾红色标记。我们建议在国际协调会议良好临床实践指南中纳入强制性临床试验报告标准，该标准应禁止限制报告的赞助商合同条款（称为封口条款），并要求及时报告结果，作为临床试验方案伦理委员会批准过程的一部分。
