Abstract
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.
Highlights
Non-commercial clinical research plays an increasingly essential role for global health
The new context of North–South collaborations often leads to complex arrangements, with multiple partners joining in international consortia that often have an ad hoc structure and operate under the limited timeframe of a specific funding period
Among international guidelines, we considered those that most often inspire national legislations: the Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), and the Good Clinical Practices (GCP) code of the World Health Organization (WHO) and of the International Conference for Harmonization (ICH)
Summary
We considered those that most often inspire national legislations: the Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), and the Good Clinical Practices (GCP) code of the World Health Organization (WHO) and of the International Conference for Harmonization (ICH). The recent European Regulation on Clinical Trials on Medicinal Products for Human Use [15] introduced an important clarification in the definition of a sponsor: “an individual, company, institution or organisation which takes responsibility for the initiation, the management and for setting up the financing of the clinical trial” This definition clarifies that the sponsor is scientifically, legally and financially responsible but, by replacing the wording “financing” with the wording “setting up the financing”, it acknowledges that the budget can either come from the sponsor itself or from sources external to the research group. For externally funded trials, the sponsor’s legal responsibility remains with the organization that initiates and manages the trial Sponsor versus funder This analysis suggests that the WHO/GCP definition of sponsor has been integrated as such into many international and national legislations, guidelines and regulations, and is not entirely adequate to cover the reality of funding arrangements in global health today (even if the difference between commercial and non-commercial sponsors is sometimes acknowledged). They have to balance the risk of a contract that does not reflect particular quality requirements (“contractual risk”) versus the risk of being unable to conduct research relevant for a given population (“ethical risk”)
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