Abstract
ObjectiveProspective 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.MethodsA 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.ResultsCTG 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.ConclusionDespite 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.
Highlights
Clinical trial registration involves prospectively registering a clinical trial’s details in a publicly accessible, webbased database called a clinical trial registry [1]
Data sources This study utilised data obtained from ClinicalTrials.gov (CTG), the Pan African Clinical Trial Registry (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN) registries
CTG had the highest number of registered trials at 2622, followed by Pan African Clinical Trials Register (PACTR) at 1501 and ISRCTN with 507 trials
Summary
Clinical trial registration involves prospectively registering a clinical trial’s details in a publicly accessible, webbased database called a clinical trial registry [1]. The Declaration had, among other things, called for the prospective registration of clinical trials in a publicly accessible platform. It tasked collaborators such as investigators, sponsors, and others to have a mechanism to disseminate the results of clinical trials ethically, irrespective of the results. The registration of clinical trials serves many purposes, such as providing a publicly accessible repository of trials that may help patients and the public decide which to enrol in, avoid needless repetition of trials, and minimise publication bias by forestalling the selective reporting of research outcomes [4, 5]. Clinical trial data submitted for registration must contain a minimum of twenty-four essential items for the Trial Registration Data Sets (TRDS) to be considered fully registered [6]
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