Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
Raffaella Ravinetto, Katelijne De Nys, Marleen Boelaert, Ermias Diro, Graeme Meintjes, Yeka Adoke, Harry Tagbor and Minne Casteels
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.
Discussion: 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.
Summary: 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.
This article can be accessed here.
- Challenges of non-commercial multi-centre North-South collaborative clinical trials
- Report from the sixth EDCTP forum in Ethiopia - Clinical trials in practice: how to achieve the best protection of the study subjects?
- Ethical criteria in clinical research in developing countries: is there a global standard?
We are very lucky to have the first author, Raffaella Ravinetto, available to answer your questions about this topic. Please follow this link to talk to her: https://globalhealthtrials.tghn.org/community/groups/group/regulations-and-guidelines/topics/911/
Dear Raffaella and co,
We are delighted to have you here to share your experience with us on this topic.Happy new year to you and family.
While we get you on here,l will like to start the discussion with this question:What are the criteria taken into consideration by a sponsor in a non commercial trail before she/ selects an organisation that sends a research project to them for funding?
Secondly,l have about ten research protocols in my keeping that have been written in diversed subjects that l have been looking for a sponsor for these projects.Is it possible that you and your team volunteer to review some of my projects and send them to sponsors that you know and we do the execution together as investigators?
l will do all that is needed to get the Ethical approval,get the sites ready for the execution of the projects and all the administrative work that needs to be done here in Yaounde Cameroon.
Since you are now versed with the subject,is it possible that you can from time to time organise some trainings for fresh doctors and nurses here in Cameroon in the selection,writing of protocol and execution of a research project from start to finish?
With your experience it will be beneficial to the World if you partner with local organizations in the execution of research projects.How ready is your organisation and you in this domain?
Lastly,Most institutions and individuals lack the institutional and managerial skills in the planning of research projects.Is your institution ready to go into the World and help with other organisations that you can work on?OR do you know of institutions that can do this?
Once more thank you for the help.
Thanks a lot for your enthusiastic response! Your questions are very complex, because each funding agency relies on a different set of rules and procedures for assessing the pertinence of the proposal, its scientific and ethical validity, the suitability of the research consortium, etc.
This platform (Global Health Trials) provides some useful guidance for researchers who need to find some orientation. For instance, the GCP course is focussed on Investigator responsibilities, so it does briefly cover the roles and responsibilities of sponsor/funder/investigator – the link is: https://globalhealthtrainingcentre.tghn.org/ich-good-clinical-practice/
There is also a list of grants which is kept as up to date as possible (by knowing that this is a very dynamic environment). The links are respectively https://globalhealthtrials.tghn.org/resources/grants/ and https://sitefinder.tghn.org/grants-and-funding-opportunities/
And there is now also a new and very useful portal, which lists the main funding agencies, by referring you directly to their respective websites: https://globalhealthtrials.tghn.org/funding/. This is really a precious tool for researchers that are looking for funders potentially interested in their research plans, or want to stay updated with open grants.
I hope this is helpful!
A lot of info here, thanks for the in-depth article.
Great job, thanks.