title: Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.
abstract: BACKGROUND
  Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations.
  
  
  CONCLUSIONS
  Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other research counterparts. Non-commercial sponsors of clinical trials should surely invest in the development of adequate legal, administrative and management skills. By acknowledging their role and specificities, and by providing them with adapted guidance, the international Good Clinical Practices codes would provide valuable guidance and support to non-commercial clinical research, whose relevance for global health is increasingly evident.
authors.affiliation: Clinical Sciences Department, Institute of Tropical Medicine Antwerp, Antwerp, Belgium. rravinetto@itg.be.|Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium. rravinetto@itg.be.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Ravinetto
authors.affiliation: Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium. katelijne.denys@uzleuven.be.|Clinical Trial Center, University Hospitals Leuven, Leuven, Belgium. katelijne.denys@uzleuven.be.
authors.forename: Katelijne
authors.initials: K
authors.lastname: De Nys
authors.affiliation: Public Health Department, Institute of Tropical Medicine Antwerp, Antwerp, Belgium. mboelaert@itg.be.
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
authors.affiliation: Department of Internal Medicine, University of Gondar, Gondar, Ethiopia. ermi_diro@yahoo.com.
authors.forename: Ermias
authors.initials: E
authors.lastname: Diro
authors.affiliation: Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa. Graeme.Meintjes@uct.ac.za.
authors.forename: Graeme
authors.initials: G
authors.lastname: Meintjes
authors.affiliation: College of Health Sciences, Makerere University School of Public Health, Kampala, Uganda. yadoke@yahoo.com.
authors.forename: Yeka
authors.initials: Y
authors.lastname: Adoke
authors.affiliation: School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. Harry.Tagbor@lshtm.ac.uk.
authors.forename: Harry
authors.initials: H
authors.lastname: Tagbor
authors.affiliation: Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium. Minne.Casteels@kuleuven.be.
authors.forename: Minne
authors.initials: M
authors.lastname: Casteels
mesh_terms: D035843:Biomedical Research / Q000191:economics* / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000592:standards*; D002986:Clinical Trials as Topic / Q000191:economics* / Q000941:ethics / Q000592:standards; D003299:Cooperative Behavior; D005378:Financial Support; D017408:Guidelines as Topic; D006801:Humans