Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

BMC International Health and Human Rights

Debate

Minne Casteels¹  Katelijne De Nys²  Raffaella Ravinetto³  Yeka Adoke⁴  Ermias Diro⁵  Graeme Meintjes⁶  Marleen Boelaert⁷  Harry Tagbor⁸ 

[1] Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium;Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium;Clinical Trial Center, University Hospitals Leuven, Leuven, Belgium;Clinical Sciences Department, Institute of Tropical Medicine Antwerp, Antwerp, Belgium;Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium;College of Health Sciences, Makerere University School of Public Health, Kampala, Uganda;Department of Internal Medicine, University of Gondar, Gondar, Ethiopia;Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa;Public Health Department, Institute of Tropical Medicine Antwerp, Antwerp, Belgium;School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana;

关键词: Funding Agency;    External Funding;    Legal Responsibility;    European Union Directive;    Funding Arrangement;   

DOI  :  10.1186/s12914-015-0073-8

 received in 2015-01-11, accepted in 2015-12-15,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundNon-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.DiscussionOur 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.SummaryNon-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.

【 授权许可】

CC BY   
© Ravinetto et al. 2015