Ravinetto Raffaella, De Nys Katelijne, Boelaert Marleen, Diro Ermias, Meintjes Graeme, Adoke Yeka, Tagbor Harry, Casteels Minne
Clinical Sciences Department, Institute of Tropical Medicine Antwerp, Antwerp, Belgium.
Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
BMC Int Health Hum Rights. 2015 Dec 30;15:34. doi: 10.1186/s12914-015-0073-8.
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.
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.
非商业性临床研究对全球健康起着越来越重要的作用。多个合作伙伴参与到在特定资助期的有限时间框架内运作的国际联盟中。一个组织（申办者）与研究伙伴合作设计并开展试验，并最终对试验的科学、伦理、监管和法律方面负责，而另一个组织，通常在北方（资助者），提供外部资金并设定资助条件。即使外部资助机制对大多数非商业研究至关重要，但对外部资助者政策的依赖可能会严重影响申办者的选择。此外，获取可用外部资金的竞争激烈，非商业申办者可能无法讨论或拒绝资助者设定的标准条件。为了查看当前定义是否充分解决了外部资助试验中申办关系的复杂性，我们研究了选定的国际指南中如何定义临床试验的“申办者”，特别关注国际药物临床试验规范准则，以及选定的欧洲和非洲法规/立法。
我们有限的分析表明，1995年世界卫生组织药物临床试验规范准则中的申办者定义已被纳入许多立法、指南和法规中，但它不足以涵盖当今全球健康领域资金安排的现实情况，即法律责任和资金来源实际上是分开的。与其他团体一致，我们建议更新国际药物临床试验规范准则以反映非商业性临床研究的现实情况。特别是，它们应明确区分商业和非商业申办者，并为非商业申办者与外部资助机构及其他研究对应方进行谈判提供指导。临床试验的非商业申办者肯定应该投资发展适当的法律、行政和管理技能。通过承认他们的作用和特殊性，并为他们提供适当的指导，国际药物临床试验规范准则将为非商业性临床研究提供有价值的指导和支持，其对全球健康的相关性日益明显。
