title: Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.
abstract: BACKGROUND
  The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres.
  
  
  METHODS
  Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials.
  
  
  CONCLUSIONS
  In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that capacity development in clinical trials is best carried out in the context of preparation for specific trials. In this regard MCTA centres involved in the phase III malaria vaccine trial were, on average, more successful at consolidating the training and infrastructure support than those centres focussing only on drug trials.
authors.affiliation: Malaria Clinical Trials Alliance, INDEPTH Network, 11 Mensah Wood Road, East Legon, PO Box KD 213, Kanda, Accra Ghana. bernhards.ogutu@indepth-network.org
authors.forename: Bernhards R
authors.initials: BR
authors.lastname: Ogutu
authors.forename: Rita
authors.initials: R
authors.lastname: Baiden
authors.forename: Diadier
authors.initials: D
authors.lastname: Diallo
authors.forename: Peter G
authors.initials: PG
authors.lastname: Smith
authors.forename: Fred N
authors.initials: FN
authors.lastname: Binka
mesh_terms: D000047:Academies and Institutes; D000349:Africa; D002986:Clinical Trials as Topic; D019058:Community Networks; D003226:Congresses as Topic; D003299:Cooperative Behavior; D006801:Humans; D007391:International Cooperation; D008288:Malaria / Q000469:parasitology / Q000517:prevention & control*; D017780:Malaria Vaccines; D016730:Program Development; D015397:Program Evaluation; D012106:Research / Q000458:organization & administration*; D012108:Research Personnel / Q000458:organization & administration*; D012109:Research Support as Topic
chemical_list: D017780:Malaria Vaccines
references.citation: Int J Epidemiol. 2006 Jun;35(3):691-704
references.pmid: 16507643
references.citation: N Engl J Med. 2008 Dec 11;359(24):2533-44
references.pmid: 19064623
references.citation: PLoS Clin Trials. 2007 May 18;2(5):e20
references.pmid: 17525792
references.citation: Malar J. 2007 Jun 12;6:79
references.pmid: 17565676
references.citation: Trop Med Int Health. 2006 Aug;11(8):1318-26
references.pmid: 16903894
references.citation: Trans R Soc Trop Med Hyg. 2008 Jan;102(1):7-10
references.pmid: 17915267
references.citation: Am J Trop Med Hyg. 2007 Dec;77(6 Suppl):282-8
references.pmid: 18165504
references.citation: Am J Trop Med Hyg. 2006 Jun;74(6):991-8
references.pmid: 16760509
references.citation: Acta Trop. 2008 Mar;105(3):222-8
references.pmid: 18279817
references.citation: Expert Opin Pharmacother. 2007 Jan;8(1):75-94
references.pmid: 17163809
references.citation: Malar J. 2007 Nov 15;6:151
references.pmid: 18005422
references.citation: Lancet. 2008 Nov 22;372(9652):1819-27
references.pmid: 18926569
references.citation: N Engl J Med. 2008 Dec 11;359(24):2521-32
references.pmid: 19064627
references.citation: Lancet. 2004 Jun 12;363(9425):1948-53
references.pmid: 15194254
references.citation: Lancet. 2002 Apr 20;359(9315):1365-72
references.pmid: 11978332
references.citation: Am J Trop Med Hyg. 2007 Dec;77(6 Suppl):181-92
references.pmid: 18165491