Cochrane South Africa, South African Medical Research Council, Cape Town, Western Cape, South Africa
Cochrane South Africa, South African Medical Research Council, Cape Town, Western Cape, South Africa.
BMJ Open. 2022 Jan 25;12(1):e057474. doi: 10.1136/bmjopen-2021-057474.
The Pan African Clinical Trials Registry (PACTR) is a WHO International Clinical Trials Registry Platform primary register, which caters for clinical trials conducted in Africa. PACTR is the first and, at present, the only member of the Network of WHO Primary Registers in Africa. The aim is to describe and report on the trends of trial records registered in PACTR.
PACTR was established in 2007 as the AIDS, Tuberculosis, and Malaria Clinical Trials Registry. The scope of the registry was then expanded in 2009 to include all diseases. This is a cross-sectional study of trials registered in PACTR from inception to 18 August 2021. A descriptive analysis of the use and trends of the following data fields: study intervention, disease condition, sex of the participants, sample size, ethics, funding and availability of results was conducted using Microsoft Excel.
The number of trials registered has increased year on year, reaching 606 trials registered in 2020. The total number of trials registered at the time of the analysis was 2998. More than half of the trials in the registry (1655 of 2998, ie, 55%) were prospectively registered. Ethical approval was received by 90% (2691 of 2998) of the registered trials. Factorial assignment as an intervention model was in 20% (589 of 2998) of the trials registered. There were 36% (1083 of 2998) completed trials, of which 3% (94 of 1083) had results available in the registry. The most dominant funding source indicated was self-funding in 23% (693 of 2998) of the registered trials, and 55% (1639 of 2998) had no funding.
Registration on PACTR continues to grow; however, our analysis shows that researchers' capacity-building is needed to understand the importance of the registry and how this information informs healthcare decisions. Promoting prospective trial registration remains critical to avoid selective reporting bias to inform research gaps.
泛非临床试验注册中心(PACTR)是世界卫生组织国际临床试验注册平台的主要注册机构,负责管理在非洲开展的临床试验。PACTR 是非洲网络中第一个也是目前唯一一个世界卫生组织主要注册机构的成员。本研究旨在描述和报告 PACTR 注册的试验记录趋势。
PACTR 于 2007 年作为艾滋病、结核病和疟疾临床试验注册中心成立。该注册中心的范围于 2009 年扩大到包括所有疾病。这是一项针对自成立以来至 2021 年 8 月 18 日在 PACTR 注册的试验的横断面研究。使用 Microsoft Excel 对以下数据字段的使用和趋势进行描述性分析:研究干预措施、疾病状况、参与者的性别、样本量、伦理、资金和结果的可用性。
试验注册数量逐年增加,2020 年达到 606 项。分析时已注册的试验总数为 2998 项。注册中心的试验中,超过一半(1655 项,占 2998 项的 55%)为前瞻性注册。已注册试验中有 90%(2691 项,占 2998 项的 90%)获得了伦理批准。作为干预模型的因子分配在已注册的 2998 项试验中占 20%(589 项)。已完成的试验占 36%(1083 项),其中 3%(94 项)在注册中心有结果可用。注册试验中最主要的资金来源是自筹资金,占 23%(693 项),55%(1639 项)无资金。
PACTR 的注册数量持续增长;然而,我们的分析表明,研究人员需要加强能力建设,以了解注册中心的重要性以及这些信息如何为医疗保健决策提供信息。促进前瞻性试验注册对于避免选择性报告偏倚以发现研究空白仍然至关重要。