Sustainable development of a GCP-compliant clinical trials platform in Africa: The malaria clinical trials alliance perspective

Malaria Journal

Volumn 9, Issue 1, 2010, Pages

  Ogutu, Bernhards R ^a   Baiden, Rita ^a   Diallo, Diadier ^a   Smith, Peter G ^b   Binka, Fred N ^a  

^a Iganga Mayuge Health and Demographic Surveillance Site   (Ghana)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

MALARIA VACCINE;

ACCREDITATION; ACHIEVEMENT; AFRICA; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); GOOD CLINICAL PRACTICE; HEALTH CARE FACILITY; HEALTH CARE QUALITY; HEALTH PROGRAM; HOSPITAL BUILDING; HUMAN; MASS MEDIUM; PERSONNEL MANAGEMENT; REVIEW; STUDY DESIGN; SUSTAINABLE DEVELOPMENT; ARTICLE; CLINICAL TRIAL; COMMUNITY CARE; COOPERATION; FINANCIAL MANAGEMENT; INTERNATIONAL COOPERATION; MALARIA; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PARASITOLOGY; PERSONNEL; PROGRAM DEVELOPMENT; RESEARCH;

ACADEMIES AND INSTITUTES; AFRICA; CLINICAL TRIALS AS TOPIC; COMMUNITY NETWORKS; CONGRESSES AS TOPIC; COOPERATIVE BEHAVIOR; HUMANS; INTERNATIONAL COOPERATION; MALARIA; MALARIA VACCINES; PROGRAM DEVELOPMENT; PROGRAM EVALUATION; RESEARCH; RESEARCH PERSONNEL; RESEARCH SUPPORT AS TOPIC;

EID: 77950920911     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/1475-2875-9-103     Document Type: Review

References (19)

1. Rowe AK, Rowe SY, Snow RW, Korenromp EL, Schellenberg JR, Stein C, Nahlen BL, Bryce J, Black RE, Steketee RW: The burden of malaria mortality among African children in the year 2000. Int J Epidemiol 2006, 35:691-704.
2. Lang TA, Kokwaro GO: Malaria drug and vaccine trials in Africa: obstacles and opportunities. Trans R Soc Trop Med Hyg 2008, 102:7-10.
3. Nosten F, White NJ: Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 2007, 77(6 Suppl):181-192.
4. Kokwaro G, Mwai L, Nzila A: Artemether/lumefantrine in the treatment of uncomplicated falciparum malaria. Expert Opin Pharmacother 2007, 8:75-94.
5. Makanga M, Premji Z, Falade C, Karbwang J, Mueller EA, Andriano K, Hunt P, De Palacios PI: Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. Am J Trop Med Hyg 2006, 74:991-998.
6. Kamya MR, Yeka A, Bukirwa H, Lugemwa M, Rwakimari JB, Staedke SG, Talisuna AO, Greenhouse B, Nosten F, Rosenthal PJ, Wabwire-Mangen F, Dorsey G: Artemether-lumefantrine versus dihydroartemisininpiperaquine for treatment of malaria: a randomized trial. PLoS Clin Trials 2007, 2:e20.
7. Vivas L, Rattray L, Stewart L, Bongard E, Robinson BL, Peters W, Croft SL: Anti-malarial efficacy of pyronaridine and artesunate in combination in vitro and in vivo. Acta Trop 2008, 105:222-228.
8. Adjuik M, Agnamey P, Babiker A, Borrmann S, Brasseur P, Cisse M, Cobelens F, Diallo S, Faucher JF, Garner P, Gikunda S, Kremsner PG, Krishna S, Lell B, Loolpapit M, Matsiegui PB, Missinou MA, Mwanza J, Ntoumi F, Olliaro P, Osimbo P, Rezbach P, Some E, Taylor WR: Amodiaquineartesunate versus amodiaquine for uncomplicated Plasmodium falciparum malaria in African children: a randomised, multicentre trial. Lancet 2002, 359:1365-1372.
9. Moran M, Guzman J, Ropers A, Jorgensen M, Mcdonald A, Potter S, Haile-Selassie H: The malaria product pipeline: Managing the trial site network, Planning for the future. 2007 [http://www.thegeorgeinstitute.org]. Health Policy Division, The George Institute for International Health. Publication
10. English M, Esamai F, Wasunna A, Were F, Ogutu B, Wamae A, Snow RW, Peshu N: Assessment of inpatient paediatric care in first referral level hospitals in 13 districts in Kenya. Lancet 2004, 363:1948-1953.
11. Tatem AJ, Snow RW, Hay SI: Mapping the environmental coverage of the INDEPTH demographic surveillance system network in rural Africa. Trop Med Int Health 2006, 11:1318-1326.
12. Kilama WL, Chilengi R, Wanga CL: Towards an African-driven malaria vaccine development program: history and activities of the African Malaria Network Trust (AMANET). Am J Trop Med Hyg 2007, 77:282-8.
13. Association of Clinical Research Professionals (ACRP): [http://www.acrpnet.org].
14. Ohrt C, Obare P, Nanakorn A, Adhiambo C, Awuondo K, O'Meara WP, Remich S, Martin K, Cook E, Chretien JP, Lucas C, Osoga J, McEvoy P, Owaga ML, Odera JS, Ogutu B: Establishing a malaria diagnostics centre of excellence in Kisumu, Kenya. Malar J 2007, 6:79.
15. Abdulla S, Sagara I, Borrmann S, D'Alessandro U, González R, Hamel M, Ogutu B, Mårtensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP, Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z: Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet 2008, 372:1819-1827.
16. Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F, Membi C, Omari S, Urassa A, Mshinda H, Jumanne A, Salim N, Shomari M, Aebi T, Schellenberg DM, Carter T, Villafana T, Demoitié MA, Dubois MC, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M: Safety and immunogenicity of RTS, S/AS02D malaria vaccine in infants. NEJM 2008, 359:2533-2544.
17. Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Mshamu S, Lang T, Gould J, Dubois MC, Demoitié MA, Stallaert JF, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, von Seidlein L: Efficacy of RTS, S/AS01E vaccine against malaria in children 5 to 17 months of age. NEJM 2008, 359:2521-2532.
18. Moran M, Guzman J, Ropers A, Jorgensen M, Mcdonald A, Potter S, Haile-Selassie H: Managing the trial site network; The malaria product pipeline: Planning for the future. 2007 [http://www.thegeorgeinstitute.org]. Health Policy Division, The George Institute for International Health. Publication
19. Okiro EA, Hay SI, Gikandi PW, Sharif SK, Noor AM, Peshu N, Marsh K, Snow RW: The decline in paediatric malaria admissions on the coast of Kenya. Malar J 2007, 6:151.