Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.
Université Paris Cité, G5 Infectious Disease Epidemiology and Analytics, Institut Pasteur, 75015, Paris, France.
Malar J. 2024 Sep 30;23(1):293. doi: 10.1186/s12936-024-05115-6.
Dissemination and outcome reporting biases are a significant problem in clinical research, with far-reaching implications for both scientific understanding and clinical decision-making. This study investigates the prevalence of dissemination- and outcome reporting biases in registered interventional malaria research.
All malaria interventional trials registered on ClinicalTrials.gov from 2010 to 2020 were identified. Subsequently, publications that matched the registration were searched. The primary outcome measures were the percentage of registered studies that resulted in subsequent publication of study results, the concordance between registered outcomes, and reported outcomes. Secondary outcomes were compliance with WHO standards for timely publication (issued in 2017) of summary study results in the respective trial registry (within 12 months of study completion) or peer-reviewed publication (within 24 months of study completion) was evaluated.
A total of 579 trials were identified on ClinicalTrials.gov, of which 544 met the inclusion criteria. Notably, almost 36.6% of these trials (199/544) were registered retrospectively, with 129 (23.7%) registered after the first patient enrolment and 70 (12.9%) following study completion. Publications were identified for 351 out of 544 registered trials (64.5%), involving 1,526,081 study participants. Conversely, publications were not found for 193 of the 544 registrations (35.5%), which aimed to enrol 417,922 study participants. Among these 544 registrations, 444 (81.6%) did not meet the WHO standard to post summary results within 12 months of primary study completion (the last visit of the last subject for collection of data on the primary outcome), while 386 out of 544 registrations (71.0%) failed to publish their results in a peer-reviewed journal within 24 months of primary study completion. Discrepancies were noted in the reported primary outcomes compared to the registered primary outcomes in 47.6% (222/466) of the published trials, and an even higher discordance rate of 73.2% (341/466 publications) for secondary outcomes.
Non-dissemination remains a significant issue in interventional malaria research, with most trials failing to meet WHO standards for timely dissemination of summary results and peer-reviewed journal publications. Additionally, outcome reporting bias is highly prevalent across malaria publications. To address these challenges, it is crucial to implement strategies that enhance the timely reporting of research findings and reduce both non-dissemination and outcome reporting bias.
传播和结果报告偏倚是临床研究中的一个重大问题，对科学理解和临床决策都有深远的影响。本研究调查了注册的干预性疟疾研究中传播和结果报告偏倚的流行情况。
从 2010 年至 2020 年，在 ClinicalTrials.gov 上确定了所有疟疾干预试验。随后，搜索与注册相匹配的出版物。主要结局指标是：已注册研究中，有多少研究最终发表了研究结果；注册结局和报告结局之间的一致性。次要结局指标是评估符合世卫组织关于及时发表（2017 年发布）摘要研究结果的标准的情况，即在研究完成后 12 个月内在各自的试验注册处或同行评议出版物中发表，或在研究完成后 24 个月内发表。
在 ClinicalTrials.gov 上共确定了 579 项试验，其中 544 项符合纳入标准。值得注意的是，这些试验中有近 36.6%（199/544）是回顾性注册的，其中 129 项（23.7%）是在第一次入组后注册的，70 项（12.9%）是在研究完成后注册的。在 544 项已注册的试验中，有 351 项（64.5%）确定了出版物，涉及 1526081 名研究参与者。相比之下，544 项注册中，有 193 项（35.5%）未发现出版物，这些注册旨在招募 417922 名研究参与者。在这 544 项注册中，444 项（81.6%）未达到世卫组织标准，即在主要研究完成后 12 个月内发布摘要结果（最后一次收集主要结局数据的最后一名受试者的最后一次就诊），而 386 项中的 544 项（71.0%）未能在主要研究完成后 24 个月内在同行评议期刊上发表结果。在已发表的试验中，有 47.6%（222/466）报告的主要结局与注册的主要结局存在差异，而在次要结局中，这一差异率更高，为 73.2%（341/466 项出版物）。
在干预性疟疾研究中，不传播仍然是一个重大问题，大多数试验未能达到世卫组织及时传播摘要结果和同行评议期刊出版物的标准。此外，疟疾出版物中普遍存在结果报告偏倚。为了解决这些挑战，必须实施各种策略，以提高研究结果的及时报告，并减少不传播和结果报告偏倚。
