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Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies : The PanACEA approach. / Mekota, Anna-Maria; Gillespie, Stephen H.; Hoelscher, Michael et al.

In: Acta tropica, Vol. 238, 106776, 01.02.2023.

Research output: Contribution to journal › Article › Academic › peer-review

Harvard

Mekota, A-M, Gillespie, SH, Hoelscher, M, Diacon, AH, Dawson, R, Churchyard, G, Sanne, I, Minja, L, Kibiki, G, Maboko, L, Lakhi, S, Joloba, M, Alabi, A, Kirenga, B, McHugh, TD, Grobusch, MP, PanACEA consortium & Boeree, MJ 2023, 'Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies: The PanACEA approach', Acta tropica, vol. 238, 106776. https://doi.org/10.1016/j.actatropica.2022.106776

APA

Mekota, A-M., Gillespie, S. H., Hoelscher, M., Diacon, A. H., Dawson, R., Churchyard, G., Sanne, I., Minja, L., Kibiki, G., Maboko, L., Lakhi, S., Joloba, M., Alabi, A., Kirenga, B., McHugh, T. D., Grobusch, M. P., PanACEA consortium, & Boeree, M. J. (2023). Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies: The PanACEA approach. Acta tropica, 238, [106776]. https://doi.org/10.1016/j.actatropica.2022.106776

Vancouver

Mekota A-M, Gillespie SH, Hoelscher M, Diacon AH, Dawson R, Churchyard G et al. Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies: The PanACEA approach. Acta tropica. 2023 Feb 1;238:106776. doi: 10.1016/j.actatropica.2022.106776

Author

Mekota, Anna-Maria ; Gillespie, Stephen H. ; Hoelscher, Michael et al. / Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies : The PanACEA approach. In: Acta tropica. 2023 ; Vol. 238.

BibTeX

@article{9c0f7b7ca7cd41009657b85e83fd0d19,
title = "Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies: The PanACEA approach",
abstract = "Introduction: The Pan-African Consortium for the Evaluation of Anti-Tuberculosis Antibiotics (PanACEA) was designed to build tuberculosis (TB) trial capacity whilst conducting clinical trials on novel and existing agents to shorten and simplify TB treatment. PanACEA has now established a dynamic network of 11 sub-Saharan clinical trial sites and four European research institutions. Objectives: In 2011, a capacity development program, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), was launched with four objectives, aiming at strengthening collaborating TB research sites to reach the ultimate goal of becoming self-sustainable institutions: networking; training; conducting clinical trials; and infrastructure scaling-up of sites. Methods: Assessment in six sub-Saharan TB-endemic countries (Gabon, Kenya, South Africa, Tanzania, Uganda and Zambia) were performed through a structured questionnaire, site visits, discussion with the PanACEA consortium, setting of milestones and identification of priorities and followed-up with evaluations of each site. The results of this needs-based assessment was then translated into capacity development measures. Results: In the initial phase, over a four-year period (March 2011 – June 2014), the programme scaled-up six sites; conducted a monitoring training program for 11 participants; funded five MSc and four PhD students, fostering gender balance; conducted four epidemiological studies; supported sites to conduct five Phase II studies and formed a sustainable platform for TB research (panacea-tb.net). Conclusion: Our experience of conducting TB clinical trials within the PanACEA programme environment of mentoring, networking and training has provided a sound platform for establishing future sustainable research centres. Our goal of facilitating emergent clinical TB trial sites to better initiate and lead research activities has been mostly successful.",
keywords = "Capacity development, Infrastructure upgrade, Networking, Sub-Saharan Africa, Sustainability, Training",
author = "Anna-Maria Mekota and Gillespie, {Stephen H.} and Michael Hoelscher and Diacon, {Andreas H.} and Rodney Dawson and Gavin Churchyard and Ian Sanne and Lilian Minja and Gibson Kibiki and Leonard Maboko and Shabir Lakhi and Moses Joloba and Abraham Alabi and Bruce Kirenga and McHugh, {Timothy D.} and Grobusch, {Martin P.} and {PanACEA consortium} and Boeree, {Martin J.}",
note = "Funding Information: This work was supported by the European & Developing Countries Clinical Trials Partnership (EDCTP) (Grant numbers: IP.2007.32011.011 , IP.2007.32011.012 , IP.2007.32011.013 ) and by the German Ministry for Education and Research (BMBF) (Grant number: 01KA0901). Funding Information: Following the assessment of the TB treatment situation in the country ( Kombila et al., 2013 ) and Lambar{\'e}n{\'e} in particular ( Stolp et al., 2013 ), we examined the socio-anthropological aspects of TB control in Gabon ( Cremers et al., 2013 ) and identified overall knowledge gaps on HIV and TB in the Central African region ( Manabe et al., 2016 ). Alongside the TB laboratory development, CERMEL partook in a first EDCTP-funded trial ({\textquoteleft}PROMPT{\textquoteright}) ( Cremers et al., 2013 ) and conducted the EDCTP-PANACEA I-funded PANEPI study. PANEPI provided a thorough baseline assessment of the regional TB epidemiology and lead to the identification of a massive MDR-TB outbreak in the region ( B{\'e}lard et al., 2016 ) and to concerns regarding the quality of care for paediatric TB patients ( B{\'e}lard et al., 2014 ), as well as regarding the limited access to second-line drugs to treat drug-resistant TB ( Ssengooba et al., 2016 ). With support from the National TB programme and the Government of Gabon, the identification of an urgent need to create MDR-TB treatment capacity led to the opening of a designated MDR-TB ward in the Centre H{\^o}pitalier Georges Rawiri in Lambar{\'e}n{\'e} and the training of qualified nurses and physicians under CERMEL guidance. Up from 2015, with expert input from the AMC senior partner, MDR-TB patients were treated successfully with the shortened {\textquoteleft}Bangladesh{\textquoteright} regimen in an ongoing observational study before WHO treatment policy was adapted and the Bangladesh regime became standard of care (43 ATEBA). Supported by CERMEL, Gabon applied for the first time to the Global fund to obtain financial backups for MDR-TB diagnostics and treatments, and the laboratory was appointed National Reference Centre for TB diagnosis. The site is now gearing up to contribute to PANACEA II clinical trials. Publisher Copyright: {\textcopyright} 2022 Elsevier B.V.",
year = "2023",
month = feb,
day = "1",
doi = "10.1016/j.actatropica.2022.106776",
language = "English",
volume = "238",
journal = "Acta tropica",
issn = "0001-706X",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Building sustainable clinical trial sites in Sub-Saharan Africa through networking, infrastructure improvement, training and conducting clinical studies

T2 - The PanACEA approach

AU - Mekota, Anna-Maria

AU - Gillespie, Stephen H.

AU - Hoelscher, Michael

AU - Diacon, Andreas H.

AU - Dawson, Rodney

AU - Churchyard, Gavin

AU - Sanne, Ian

AU - Minja, Lilian

AU - Kibiki, Gibson

AU - Maboko, Leonard

AU - Lakhi, Shabir

AU - Joloba, Moses

AU - Alabi, Abraham

AU - Kirenga, Bruce

AU - McHugh, Timothy D.

AU - Grobusch, Martin P.

AU - PanACEA consortium

AU - Boeree, Martin J.

N1 - Funding Information: This work was supported by the European & Developing Countries Clinical Trials Partnership (EDCTP) (Grant numbers: IP.2007.32011.011 , IP.2007.32011.012 , IP.2007.32011.013 ) and by the German Ministry for Education and Research (BMBF) (Grant number: 01KA0901). Funding Information: Following the assessment of the TB treatment situation in the country ( Kombila et al., 2013 ) and Lambaréné in particular ( Stolp et al., 2013 ), we examined the socio-anthropological aspects of TB control in Gabon ( Cremers et al., 2013 ) and identified overall knowledge gaps on HIV and TB in the Central African region ( Manabe et al., 2016 ). Alongside the TB laboratory development, CERMEL partook in a first EDCTP-funded trial (‘PROMPT’) ( Cremers et al., 2013 ) and conducted the EDCTP-PANACEA I-funded PANEPI study. PANEPI provided a thorough baseline assessment of the regional TB epidemiology and lead to the identification of a massive MDR-TB outbreak in the region ( Bélard et al., 2016 ) and to concerns regarding the quality of care for paediatric TB patients ( Bélard et al., 2014 ), as well as regarding the limited access to second-line drugs to treat drug-resistant TB ( Ssengooba et al., 2016 ). With support from the National TB programme and the Government of Gabon, the identification of an urgent need to create MDR-TB treatment capacity led to the opening of a designated MDR-TB ward in the Centre Hôpitalier Georges Rawiri in Lambaréné and the training of qualified nurses and physicians under CERMEL guidance. Up from 2015, with expert input from the AMC senior partner, MDR-TB patients were treated successfully with the shortened ‘Bangladesh’ regimen in an ongoing observational study before WHO treatment policy was adapted and the Bangladesh regime became standard of care (43 ATEBA). Supported by CERMEL, Gabon applied for the first time to the Global fund to obtain financial backups for MDR-TB diagnostics and treatments, and the laboratory was appointed National Reference Centre for TB diagnosis. The site is now gearing up to contribute to PANACEA II clinical trials. Publisher Copyright: © 2022 Elsevier B.V.

PY - 2023/2/1

Y1 - 2023/2/1

N2 - Introduction: The Pan-African Consortium for the Evaluation of Anti-Tuberculosis Antibiotics (PanACEA) was designed to build tuberculosis (TB) trial capacity whilst conducting clinical trials on novel and existing agents to shorten and simplify TB treatment. PanACEA has now established a dynamic network of 11 sub-Saharan clinical trial sites and four European research institutions. Objectives: In 2011, a capacity development program, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), was launched with four objectives, aiming at strengthening collaborating TB research sites to reach the ultimate goal of becoming self-sustainable institutions: networking; training; conducting clinical trials; and infrastructure scaling-up of sites. Methods: Assessment in six sub-Saharan TB-endemic countries (Gabon, Kenya, South Africa, Tanzania, Uganda and Zambia) were performed through a structured questionnaire, site visits, discussion with the PanACEA consortium, setting of milestones and identification of priorities and followed-up with evaluations of each site. The results of this needs-based assessment was then translated into capacity development measures. Results: In the initial phase, over a four-year period (March 2011 – June 2014), the programme scaled-up six sites; conducted a monitoring training program for 11 participants; funded five MSc and four PhD students, fostering gender balance; conducted four epidemiological studies; supported sites to conduct five Phase II studies and formed a sustainable platform for TB research (panacea-tb.net). Conclusion: Our experience of conducting TB clinical trials within the PanACEA programme environment of mentoring, networking and training has provided a sound platform for establishing future sustainable research centres. Our goal of facilitating emergent clinical TB trial sites to better initiate and lead research activities has been mostly successful.

AB - Introduction: The Pan-African Consortium for the Evaluation of Anti-Tuberculosis Antibiotics (PanACEA) was designed to build tuberculosis (TB) trial capacity whilst conducting clinical trials on novel and existing agents to shorten and simplify TB treatment. PanACEA has now established a dynamic network of 11 sub-Saharan clinical trial sites and four European research institutions. Objectives: In 2011, a capacity development program, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), was launched with four objectives, aiming at strengthening collaborating TB research sites to reach the ultimate goal of becoming self-sustainable institutions: networking; training; conducting clinical trials; and infrastructure scaling-up of sites. Methods: Assessment in six sub-Saharan TB-endemic countries (Gabon, Kenya, South Africa, Tanzania, Uganda and Zambia) were performed through a structured questionnaire, site visits, discussion with the PanACEA consortium, setting of milestones and identification of priorities and followed-up with evaluations of each site. The results of this needs-based assessment was then translated into capacity development measures. Results: In the initial phase, over a four-year period (March 2011 – June 2014), the programme scaled-up six sites; conducted a monitoring training program for 11 participants; funded five MSc and four PhD students, fostering gender balance; conducted four epidemiological studies; supported sites to conduct five Phase II studies and formed a sustainable platform for TB research (panacea-tb.net). Conclusion: Our experience of conducting TB clinical trials within the PanACEA programme environment of mentoring, networking and training has provided a sound platform for establishing future sustainable research centres. Our goal of facilitating emergent clinical TB trial sites to better initiate and lead research activities has been mostly successful.

KW - Capacity development

KW - Infrastructure upgrade

KW - Networking

KW - Sub-Saharan Africa

KW - Sustainability

KW - Training

UR - http://www.scopus.com/inward/record.url?scp=85144796553&partnerID=8YFLogxK

U2 - 10.1016/j.actatropica.2022.106776

DO - 10.1016/j.actatropica.2022.106776

M3 - Article

C2 - 36502888

VL - 238

JO - Acta tropica

JF - Acta tropica

SN - 0001-706X

M1 - 106776

ER -

ID: 30452916