TY - JOUR
T1 - Building a national framework for multicentre research and clinical trials
T2 - Experience from the Nigeria Implementation Science Alliance
AU - Olawepo, John Olajide
AU - Ezeanolue, Echezona Edozie
AU - Ekenna, Adanma
AU - Ogunsola, Olabanjo O.
AU - Itanyi, Ijeoma Uchenna
AU - Jedy-Agba, Elima
AU - Egbo, Emmanuel
AU - Onwuchekwa, Chukwudi
AU - Ezeonu, Alexandra
AU - Ajibola, Abiola
AU - Olakunde, Babayemi O.
AU - Majekodunmi, Omololuoye
AU - Ogidi, Amaka G.
AU - Chukwuorji, John Bosco
AU - Lasebikan, Nwamaka
AU - Dakum, Patrick
AU - Okonkwo, Prosper
AU - Oyeledun, Bolanle
AU - Oko, John
AU - Khamofu, Hadiza
AU - Ikpeazu, Akudo
AU - Nwokwu, Uchechukwu Emmanuel
AU - Aliyu, Gambo
AU - Shittu, Oladapo
AU - Rositch, Anne F.
AU - Powell, Byron J.
AU - Conserve, Donaldson F.
AU - Aarons, Gregory A.
AU - Olutola, Ayodotun
N1 - Funding Information:
Acknowledgements Health Facilities—All the hospital administrators and the facility clinical teams (physicians, nurses, and M&E focal persons).CTAIR—Bilikis Akindele, Stephen Orafa, Chima OnokaNISA—Ahmad Aliyu, Uche Okezie, Samuel Cheure, Chika Obiora-Okafo, Collins Imarhiagbe, Omowumi Obisesan, Bidemi Harry-ErinOther Collaborators—Timothy Efuntoye, Dolapo Ogundehin, Dina Patel, George Siberry, Rachel Sturke.Infrastructural support—Microsoft (for the Microsoft nonprofit technology enablement grant), Google (for the Google nonprofit technology grants) and Research Electronic Data Collection Capture (REDCap).
Publisher Copyright:
©
PY - 2022/4/21
Y1 - 2022/4/21
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Cohort study
KW - HIV
KW - Maternal health
KW - Public Health
UR - http://www.scopus.com/inward/record.url?scp=85130964519&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130964519&partnerID=8YFLogxK
U2 - 10.1136/bmjgh-2021-008241
DO - 10.1136/bmjgh-2021-008241
M3 - Article
C2 - 35450861
AN - SCOPUS:85130964519
SN - 2059-7908
VL - 7
JO - BMJ Global Health
JF - BMJ Global Health
IS - 4
M1 - e006419
ER -