Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine
Abstract Background A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an...
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ftdoajarticles:oai:doaj.org/article:008158d7418049a6a85bf316e6e6a71b 2023-05-15T15:12:56+02:00 Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards 2011-08-01T00:00:00Z https://doi.org/10.1186/1475-2875-10-223 https://doaj.org/article/008158d7418049a6a85bf316e6e6a71b EN eng BMC http://www.malariajournal.com/content/10/1/223 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-10-223 1475-2875 https://doaj.org/article/008158d7418049a6a85bf316e6e6a71b Malaria Journal, Vol 10, Iss 1, p 223 (2011) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2011 ftdoajarticles https://doi.org/10.1186/1475-2875-10-223 2022-12-30T22:49:46Z Abstract Background A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres. Methods Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners. Results A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials. Conclusion Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials. Trial registration Clinicaltrials.gov NCT00866619 Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 10 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres. Methods Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners. Results A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials. Conclusion Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials. Trial registration Clinicaltrials.gov NCT00866619 |
format |
Article in Journal/Newspaper |
author |
Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards |
author_facet |
Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards |
author_sort |
Carter Terrell |
title |
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
title_short |
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
title_full |
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
title_fullStr |
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
title_full_unstemmed |
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
title_sort |
development of standardized laboratory methods and quality processes for a phase iii study of the rts, s/as01 candidate malaria vaccine |
publisher |
BMC |
publishDate |
2011 |
url |
https://doi.org/10.1186/1475-2875-10-223 https://doaj.org/article/008158d7418049a6a85bf316e6e6a71b |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 10, Iss 1, p 223 (2011) |
op_relation |
http://www.malariajournal.com/content/10/1/223 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-10-223 1475-2875 https://doaj.org/article/008158d7418049a6a85bf316e6e6a71b |
op_doi |
https://doi.org/10.1186/1475-2875-10-223 |
container_title |
Malaria Journal |
container_volume |
10 |
container_issue |
1 |
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1766343552761069568 |