Title: Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
Authors: Ravinetto, Raffaella ×
De Nys, Katelijne
Boelaert, Marleen
Diro, Ermias
Meintjes, Graeme
Adoke, Yeka
Tagbor, Harry
Casteels, Minne #
Issue Date: 2015
Publisher: BioMed Central
Series Title: BMC International Health and Human Rights vol:15 issue:1 pages:34
Article number: 10.1186/s12914-015-0073-8
Abstract: 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.
ISSN: 1472-698X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Non-KU Leuven Association publications
× corresponding author
# (joint) last author

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