title: Challenges of non-commercial multicentre North-South collaborative clinical trials.
abstract: The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. According to the recent experience of a large multicentre trial on antimalarials, major challenges result from the complexity of multiple ethical review, the costs of in-depth monitoring at several sites, setting up an adequate Good Clinical Laboratory Practices (GCLP) framework, lack of insurers in host countries, and lack of adequate non-commercial data management software. Public research funding agencies need to consider these challenges in their funding policies. They also could support common spaces where North-South collaborative research groups may share critical information, such as on research insurance and open-source, GCP-compliant software. WHO should update its GCP guidelines, which date back to 1995, to incorporate the perspectives and needs of non-commercial clinical research.
authors.forename: Raffaella M
authors.initials: RM
authors.lastname: Ravinetto
authors.forename: Ambrose
authors.initials: A
authors.lastname: Talisuna
authors.forename: Maaike
authors.initials: M
authors.lastname: De Crop
authors.forename: Harry
authors.initials: H
authors.lastname: van Loen
authors.forename: Joris
authors.initials: J
authors.lastname: Menten
authors.forename: Chantal
authors.initials: C
authors.lastname: Van Overmeir
authors.forename: Halidou
authors.initials: H
authors.lastname: Tinto
authors.forename: Raquel
authors.initials: R
authors.lastname: Gonzalez
authors.forename: Martin
authors.initials: M
authors.lastname: Meremikwu
authors.forename: Carolyn
authors.initials: C
authors.lastname: Nabasuma
authors.forename: Ghyslain M
authors.initials: GM
authors.lastname: Ngoma
authors.forename: Corine
authors.initials: C
authors.lastname: Karema
authors.forename: Yeka
authors.initials: Y
authors.lastname: Adoke
authors.forename: Mike
authors.initials: M
authors.lastname: Chaponda
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Van Geertruyden
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D002986:Clinical Trials as Topic; D003299:Cooperative Behavior; D006801:Humans; D007391:International Cooperation; D017410:Practice Guidelines as Topic / Q000592:standards*; D014944:World Health Organization