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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine
Malaria Journal, Volume 10, Article 223, Year 2011
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Description
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. © 2011 Swysen et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Swysen, Christine
Unknown Affiliation
Bruls, Myriam
Unknown Affiliation
Oyakhirome, Sunny
Unknown Affiliation
Drakeley, Chris J.
Unknown Affiliation
Okech, Brenda Apio
Unknown Affiliation
Carter, Terrell C.
Unknown Affiliation
Dusé, Adriano G.
Unknown Affiliation
Reijman, Andrea
Unknown Affiliation
Ingram, Charlotte
Unknown Affiliation
Frean, John Andrew
Unknown Affiliation
Ogutu, Bernhards R.
Unknown Affiliation
Statistics
Citations: 79
Authors: 11
Affiliations: 10
Identifiers
Doi:
10.1186/1475-2875-10-223
e-ISSN:
14752875
Research Areas
Health System And Policy
Infectious Diseases