Strengthening laboratory capacity for HIV vaccine clinical trials and epidemiological studies in Eastern and Southern Africa [version 1; peer review: 2 approved with reservations]
Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites, poor infrastructure, lack of well-trained technical personnel, and inadequate laboratory quality management Systems. We describe our approach...
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Published in | F1000 research Vol. 11; p. 72 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
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2022
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Abstract | Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites, poor infrastructure, lack of well-trained technical personnel, and inadequate laboratory quality management Systems. We describe our approach to establishing sustainable laboratory capacity for clinical trials in Africa.
Methods: IAVI identified 9 CRCs where a capacity building program that supports immunology and clinical testing was established. Information from the 9 CRCs was collected retrospectively and compiled in Microsoft excel for descriptive statistics. Mapping was done in Quantum Geographic information system.
Results: Newly built and refurbished laboratories have been equipped with the required testing laboratory equipment. All CRC laboratories (n=10, 100%) received Good Clinical Laboratory Practice (GCLP) accreditation between 2004 and 2016, and accreditation maintained annually. A total of 89 audits were done between 2005-2019. KAVI and KEMRI had the highest number of audits (n=11, 12.4%). IAVI successfully trained a total of 1811 individual, of which (n=1130, 62.7%) trained on GCLP, (n=330, 18.3%) Quality Management Systems, (n=311, 17,2%) laboratory techniques and (n=32,1.8%) between 2004 and 2021. All the 13 Assays were registered in either College of American pathologist (CAP) or Royal college of pathologists of Australasia (RCPA) for Proficiency testing.
Conclusion: The establishment of GCLP accredited laboratories and well-trained personnel has created centers of excellence and it has enabled them to attract independent competitive research funding. The GCLP accreditation and standardized testing procedures ensured reliable and accurate data, especially important for multi-country and multi-center studies. |
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AbstractList | Background:
Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites, poor infrastructure, lack of well-trained technical personnel, and inadequate laboratory quality management Systems. We describe our approach to establishing sustainable laboratory capacity for clinical trials in Africa.
Methods:
IAVI identified 9 CRCs where a capacity building program that supports immunology and clinical testing was established. Information from the 9 CRCs was collected retrospectively and compiled in Microsoft excel for descriptive statistics. Mapping was done in Quantum Geographic information system.
Results:
Newly built and refurbished laboratories have been equipped with the required testing laboratory equipment. All CRC laboratories (n=10, 100%) received Good Clinical Laboratory Practice (GCLP) accreditation between 2004 and 2016, and accreditation maintained annually. A total of 89 audits were done between 2005-2019. KAVI and KEMRI had the highest number of audits (n=11, 12.4%). IAVI successfully trained a total of 1811 individual, of which (n=1130, 62.7%) trained on GCLP, (n=330, 18.3%) Quality Management Systems, (n=311, 17,2%) laboratory techniques and (n=32,1.8%) between 2004 and 2021. All the 13 Assays were registered in either College of American pathologist (CAP) or Royal college of pathologists of Australasia (RCPA) for Proficiency testing.
Conclusion:
The establishment of GCLP accredited laboratories and well-trained personnel has created centers of excellence and it has enabled them to attract independent competitive research funding. The GCLP accreditation and standardized testing procedures ensured reliable and accurate data, especially important for multi-country and multi-center studies. Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites, poor infrastructure, lack of well-trained technical personnel, and inadequate laboratory quality management Systems. We describe our approach to establishing sustainable laboratory capacity for clinical trials in Africa. Methods: IAVI identified 9 CRCs where a capacity building program that supports immunology and clinical testing was established. Information from the 9 CRCs was collected retrospectively and compiled in Microsoft excel for descriptive statistics. Mapping was done in Quantum Geographic information system. Results: Newly built and refurbished laboratories have been equipped with the required testing laboratory equipment. All CRC laboratories (n=10, 100%) received Good Clinical Laboratory Practice (GCLP) accreditation between 2004 and 2016, and accreditation maintained annually. A total of 89 audits were done between 2005-2019. KAVI and KEMRI had the highest number of audits (n=11, 12.4%). IAVI successfully trained a total of 1811 individual, of which (n=1130, 62.7%) trained on GCLP, (n=330, 18.3%) Quality Management Systems, (n=311, 17,2%) laboratory techniques and (n=32,1.8%) between 2004 and 2021. All the 13 Assays were registered in either College of American pathologist (CAP) or Royal college of pathologists of Australasia (RCPA) for Proficiency testing. Conclusion: The establishment of GCLP accredited laboratories and well-trained personnel has created centers of excellence and it has enabled them to attract independent competitive research funding. The GCLP accreditation and standardized testing procedures ensured reliable and accurate data, especially important for multi-country and multi-center studies. |
Author | Ochiel, Daniel Maraka, Moureen Mshai, Mercy Gilmour, Jill Chetty, Paramesh Farah, Bashir Murungi, Linda |
Author_xml | – sequence: 1 givenname: Bashir orcidid: 0000-0002-2666-2243 surname: Farah fullname: Farah, Bashir email: Bfarah@iavi.org organization: IAVI Global Headquarters, New York NY, USA – sequence: 2 givenname: Moureen surname: Maraka fullname: Maraka, Moureen organization: IAVI Global Headquarters, New York NY, USA – sequence: 3 givenname: Mercy surname: Mshai fullname: Mshai, Mercy organization: IAVI Global Headquarters, New York NY, USA – sequence: 4 givenname: Paramesh surname: Chetty fullname: Chetty, Paramesh organization: IAVI, Southern Africa regional office, Centurion, South Africa – sequence: 5 givenname: Linda surname: Murungi fullname: Murungi, Linda organization: IAVI Global Headquarters, New York NY, USA – sequence: 6 givenname: Daniel surname: Ochiel fullname: Ochiel, Daniel organization: IAVI Global Headquarters, New York NY, USA – sequence: 7 givenname: Jill surname: Gilmour fullname: Gilmour, Jill organization: IAVI Human Immunology Laboratory, Imperial College, London, UK |
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Cites_doi | 10.1097/QAI.0000000000000038 10.1016/bs.acc.2019.01.006 10.1371/journal.pmed.1000067 10.1057/jphp.2011.57 10.1016/j.cmi.2017.05.007 10.1186/s12960-020-00521-8 10.1371/journal.pone.0013592 10.1309/AJCPH1SKQ1HNWGHF 10.1086/367702 10.1086/499363 10.1515/jomb-2017-0025 10.4049/jimmunol.174.1.449 10.1586/14760584.2013.855612 10.1515/cclm-2017-1179 10.1373/clinchem.2011.168641 10.4314/pamj.v10i0.72235 10.6084/m9.figshare.16817482.v1 |
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Copyright | Copyright: © 2022 Farah B et al. |
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Keywords | Clinical GCLP Strengthening Accreditation Capacity |
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Snippet | Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites,... Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites,... |
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Title | Strengthening laboratory capacity for HIV vaccine clinical trials and epidemiological studies in Eastern and Southern Africa [version 1; peer review: 2 approved with reservations] |
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