title: 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 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00866619.
authors.affiliation: GlaxoSmithKline Biologicals, Rixensart, Belgium. christine.swysen@gskbio.com
authors.forename: Christine
authors.initials: C
authors.lastname: Swysen
authors.forename: Johan
authors.initials: J
authors.lastname: Vekemans
authors.forename: Myriam
authors.initials: M
authors.lastname: Bruls
authors.forename: Sunny
authors.initials: S
authors.lastname: Oyakhirome
authors.forename: Chris
authors.initials: C
authors.lastname: Drakeley
authors.forename: Peter
authors.initials: P
authors.lastname: Kremsner
authors.forename: Brian
authors.initials: B
authors.lastname: Greenwood
authors.forename: Opokua
authors.initials: O
authors.lastname: Ofori-Anyinam
authors.forename: Brenda
authors.initials: B
authors.lastname: Okech
authors.forename: Tonya
authors.initials: T
authors.lastname: Villafana
authors.forename: Terrell
authors.initials: T
authors.lastname: Carter
authors.forename: Barbara
authors.initials: B
authors.lastname: Savarese
authors.forename: Adriano
authors.initials: A
authors.lastname: Duse
authors.forename: Andrea
authors.initials: A
authors.lastname: Reijman
authors.forename: Charlotte
authors.initials: C
authors.lastname: Ingram
authors.forename: John
authors.initials: J
authors.lastname: Frean
authors.forename: Bernhards
authors.initials: B
authors.lastname: Ogutu
mesh_terms: D000349:Africa; D001331:Automation / Q000379:methods / Q000592:standards; D035843:Biomedical Research / Q000592:standards*; D001769:Blood / Q000469:parasitology; D001786:Blood Glucose / Q000032:analysis; D019411:Clinical Laboratory Techniques / Q000379:methods* / Q000592:standards; D003625:Data Collection / Q000592:standards*; D006801:Humans; D019344:Lactic Acid / Q000097:blood; D008288:Malaria / Q000175:diagnosis* / Q000469:parasitology; D017780:Malaria Vaccines / Q000276:immunology*; D018512:Parasitemia / Q000175:diagnosis* / Q000469:parasitology; D011785:Quality Assurance, Health Care / Q000379:methods*; D011859:Radiography / Q000379:methods / Q000592:standards
chemical_list: D001786:Blood Glucose; D017780:Malaria Vaccines; D019344:Lactic Acid