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Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance

There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locall...

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Autores principales: Olawepo, John Olajide, Ezeanolue, Echezona Edozie, Ekenna, Adanma, Ogunsola, Olabanjo O, Itanyi, Ijeoma Uchenna, Jedy-Agba, Elima, Egbo, Emmanuel, Onwuchekwa, Chukwudi, Ezeonu, Alexandra, Ajibola, Abiola, Olakunde, Babayemi O, Majekodunmi, Omololuoye, Ogidi, Amaka G, Chukwuorji, JohnBosco, Lasebikan, Nwamaka, Dakum, Patrick, Okonkwo, Prosper, Oyeledun, Bolanle, Oko, John, Khamofu, Hadiza, Ikpeazu, Akudo, Nwokwu, Uchechukwu Emmanuel, Aliyu, Gambo, Shittu, Oladapo, Rositch, Anne F, Powell, Byron J, Conserve, Donaldson F, Aarons, Gregory A, Olutola, Ayodotun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024272/
https://www.ncbi.nlm.nih.gov/pubmed/35450861
http://dx.doi.org/10.1136/bmjgh-2021-008241
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author Olawepo, John Olajide
Ezeanolue, Echezona Edozie
Ekenna, Adanma
Ogunsola, Olabanjo O
Itanyi, Ijeoma Uchenna
Jedy-Agba, Elima
Egbo, Emmanuel
Onwuchekwa, Chukwudi
Ezeonu, Alexandra
Ajibola, Abiola
Olakunde, Babayemi O
Majekodunmi, Omololuoye
Ogidi, Amaka G
Chukwuorji, JohnBosco
Lasebikan, Nwamaka
Dakum, Patrick
Okonkwo, Prosper
Oyeledun, Bolanle
Oko, John
Khamofu, Hadiza
Ikpeazu, Akudo
Nwokwu, Uchechukwu Emmanuel
Aliyu, Gambo
Shittu, Oladapo
Rositch, Anne F
Powell, Byron J
Conserve, Donaldson F
Aarons, Gregory A
Olutola, Ayodotun
author_facet Olawepo, John Olajide
Ezeanolue, Echezona Edozie
Ekenna, Adanma
Ogunsola, Olabanjo O
Itanyi, Ijeoma Uchenna
Jedy-Agba, Elima
Egbo, Emmanuel
Onwuchekwa, Chukwudi
Ezeonu, Alexandra
Ajibola, Abiola
Olakunde, Babayemi O
Majekodunmi, Omololuoye
Ogidi, Amaka G
Chukwuorji, JohnBosco
Lasebikan, Nwamaka
Dakum, Patrick
Okonkwo, Prosper
Oyeledun, Bolanle
Oko, John
Khamofu, Hadiza
Ikpeazu, Akudo
Nwokwu, Uchechukwu Emmanuel
Aliyu, Gambo
Shittu, Oladapo
Rositch, Anne F
Powell, Byron J
Conserve, Donaldson F
Aarons, Gregory A
Olutola, Ayodotun
author_sort Olawepo, John Olajide
collection PubMed
description There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locally driven infrastructure for multicentre research and trials in Nigeria known as the Nigeria Implementation Science Alliance Model Innovation and Research Centres (NISA-MIRCs). We used a participatory approach to establish a research network of 21 high-volume health facilities selected from all 6 geopolitical zones in Nigeria capable of conducting clinical trials, implementation research using effectiveness-implementation hybrid designs and health system research. The NISA-MIRCs have a cumulative potential to recruit 60 000 women living with HIV and an age-matched cohort of HIV-uninfected women. We conducted a needs assessment, convened several stakeholder outreaches and engagement sessions, and established a governance structure. Additionally, we selected and trained a core research team, developed criteria for site selection, assessed site readiness for research and obtained ethical approval from a single national institutional review board. We used the Exploration, Preparation, Implementation, Sustainment framework to guide our reporting of the process in the development of this network. The NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support collaborative research, inform policy decisions and thereby fill a significant research infrastructure gap in Africa’s most populous country.
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spelling pubmed-90242722022-05-06 Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance Olawepo, John Olajide Ezeanolue, Echezona Edozie Ekenna, Adanma Ogunsola, Olabanjo O Itanyi, Ijeoma Uchenna Jedy-Agba, Elima Egbo, Emmanuel Onwuchekwa, Chukwudi Ezeonu, Alexandra Ajibola, Abiola Olakunde, Babayemi O Majekodunmi, Omololuoye Ogidi, Amaka G Chukwuorji, JohnBosco Lasebikan, Nwamaka Dakum, Patrick Okonkwo, Prosper Oyeledun, Bolanle Oko, John Khamofu, Hadiza Ikpeazu, Akudo Nwokwu, Uchechukwu Emmanuel Aliyu, Gambo Shittu, Oladapo Rositch, Anne F Powell, Byron J Conserve, Donaldson F Aarons, Gregory A Olutola, Ayodotun BMJ Glob Health Practice There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locally driven infrastructure for multicentre research and trials in Nigeria known as the Nigeria Implementation Science Alliance Model Innovation and Research Centres (NISA-MIRCs). We used a participatory approach to establish a research network of 21 high-volume health facilities selected from all 6 geopolitical zones in Nigeria capable of conducting clinical trials, implementation research using effectiveness-implementation hybrid designs and health system research. The NISA-MIRCs have a cumulative potential to recruit 60 000 women living with HIV and an age-matched cohort of HIV-uninfected women. We conducted a needs assessment, convened several stakeholder outreaches and engagement sessions, and established a governance structure. Additionally, we selected and trained a core research team, developed criteria for site selection, assessed site readiness for research and obtained ethical approval from a single national institutional review board. We used the Exploration, Preparation, Implementation, Sustainment framework to guide our reporting of the process in the development of this network. The NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support collaborative research, inform policy decisions and thereby fill a significant research infrastructure gap in Africa’s most populous country. BMJ Publishing Group 2022-04-21 /pmc/articles/PMC9024272/ /pubmed/35450861 http://dx.doi.org/10.1136/bmjgh-2021-008241 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Practice
Olawepo, John Olajide
Ezeanolue, Echezona Edozie
Ekenna, Adanma
Ogunsola, Olabanjo O
Itanyi, Ijeoma Uchenna
Jedy-Agba, Elima
Egbo, Emmanuel
Onwuchekwa, Chukwudi
Ezeonu, Alexandra
Ajibola, Abiola
Olakunde, Babayemi O
Majekodunmi, Omololuoye
Ogidi, Amaka G
Chukwuorji, JohnBosco
Lasebikan, Nwamaka
Dakum, Patrick
Okonkwo, Prosper
Oyeledun, Bolanle
Oko, John
Khamofu, Hadiza
Ikpeazu, Akudo
Nwokwu, Uchechukwu Emmanuel
Aliyu, Gambo
Shittu, Oladapo
Rositch, Anne F
Powell, Byron J
Conserve, Donaldson F
Aarons, Gregory A
Olutola, Ayodotun
Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
title Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
title_full Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
title_fullStr Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
title_full_unstemmed Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
title_short Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
title_sort building a national framework for multicentre research and clinical trials: experience from the nigeria implementation science alliance
topic Practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024272/
https://www.ncbi.nlm.nih.gov/pubmed/35450861
http://dx.doi.org/10.1136/bmjgh-2021-008241
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