Department of Vaccines and Immunity, Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
Unit of Epidemiology and Biostatistics, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
Trials. 2021 Jul 21;22(1):472. doi: 10.1186/s13063-021-05423-1.
Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020.
A cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis.
CTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018-2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias.
Despite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.
临床试验的前瞻性注册是一项伦理、科学和法律要求，具有多种功能，包括最大限度地减少研究浪费和发表偏倚。撒哈拉以南非洲（SSA）在过去几年中越来越多地主办临床试验，但关于 SSA 临床试验注册和报告趋势的文献有限。因此，我们旨在确定 2010 年至 2020 年 7 月期间在 SSA 国家注册的临床试验趋势。
采用横断面研究设计，描述 2010 年 1 月 1 日至 2020 年 7 月 31 日期间在 SSA 进行的临床试验类型。检索的注册处包括 ClinicalTrials.gov（CTG）、泛非临床试验注册处（PACTR）和国际标准随机对照试验编号（ISRCTN）。数据提取到 Excel 中，并导入 STATA 进行描述性分析。
CTG 注册的试验数量最多，为 2622 项，其次是 PACTR，为 1501 项，ISRCTN 为 507 项。试验数量从 2010 年开始逐渐增加，并在 2018-2019 年达到峰值。随机试验是最常见的类型，在三个注册处至少占 80%。针对感染/寄生虫的药物进行的三期试验占多数。少数已完成的试验已公布结果：ISRCTN 为 58%，CTG 为 16.5%，因此表明存在发表偏倚。
尽管在此期间注册的临床试验数量逐渐增加，但最近的趋势表明该地区注册的试验数量有所下降。加强国家和地区监管能力将改善临床试验注册，并最大限度地减少完成临床试验的报告偏倚。
