Cargando…

Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

OBJECTIVE: 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 li...

Descripción completa

Detalles Bibliográficos
Autores principales: Edem, Bassey, Onwuchekwa, Chukwuemeka, Wariri, Oghenebrume, Nkereuwem, Esin, Nkereuwem, Oluwatosin O., Williams, Victor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293494/
https://www.ncbi.nlm.nih.gov/pubmed/34289892
http://dx.doi.org/10.1186/s13063-021-05423-1
_version_ 1783725051000913920
author Edem, Bassey
Onwuchekwa, Chukwuemeka
Wariri, Oghenebrume
Nkereuwem, Esin
Nkereuwem, Oluwatosin O.
Williams, Victor
author_facet Edem, Bassey
Onwuchekwa, Chukwuemeka
Wariri, Oghenebrume
Nkereuwem, Esin
Nkereuwem, Oluwatosin O.
Williams, Victor
author_sort Edem, Bassey
collection PubMed
description OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05423-1.
format Online
Article
Text
id pubmed-8293494
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-82934942021-07-21 Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries Edem, Bassey Onwuchekwa, Chukwuemeka Wariri, Oghenebrume Nkereuwem, Esin Nkereuwem, Oluwatosin O. Williams, Victor Trials Research OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05423-1. BioMed Central 2021-07-21 /pmc/articles/PMC8293494/ /pubmed/34289892 http://dx.doi.org/10.1186/s13063-021-05423-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Edem, Bassey
Onwuchekwa, Chukwuemeka
Wariri, Oghenebrume
Nkereuwem, Esin
Nkereuwem, Oluwatosin O.
Williams, Victor
Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
title Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
title_full Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
title_fullStr Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
title_full_unstemmed Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
title_short Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
title_sort trends in clinical trial registration in sub-saharan africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293494/
https://www.ncbi.nlm.nih.gov/pubmed/34289892
http://dx.doi.org/10.1186/s13063-021-05423-1
work_keys_str_mv AT edembassey trendsinclinicaltrialregistrationinsubsaharanafricabetween2010and2020acrosssectionalreviewofthreeclinicaltrialregistries
AT onwuchekwachukwuemeka trendsinclinicaltrialregistrationinsubsaharanafricabetween2010and2020acrosssectionalreviewofthreeclinicaltrialregistries
AT waririoghenebrume trendsinclinicaltrialregistrationinsubsaharanafricabetween2010and2020acrosssectionalreviewofthreeclinicaltrialregistries
AT nkereuwemesin trendsinclinicaltrialregistrationinsubsaharanafricabetween2010and2020acrosssectionalreviewofthreeclinicaltrialregistries
AT nkereuwemoluwatosino trendsinclinicaltrialregistrationinsubsaharanafricabetween2010and2020acrosssectionalreviewofthreeclinicaltrialregistries
AT williamsvictor trendsinclinicaltrialregistrationinsubsaharanafricabetween2010and2020acrosssectionalreviewofthreeclinicaltrialregistries