groups » Regulations and Guidelines » Ask the expert: Sponsorship in non-commercial clinical trials

Exciting News!

We are very lucky to have expert Raffaella Ravinetto (Clinical Sciences Department, Institute of Tropical Medicine Antwerp) ready to answer your questions about the issue of sponsorship in non-commercial trials.

This is very exciting, as Raffaella and colleagues have just released a paper on this issue: https://globalhealthtrials.tghn.org/articles/sponsorship-non-commercial-clinical-trials/. Raffaella is ready and waiting to answer your questions in relation to the very common confusions that arise over the role of the sponsor, and the line between sponsor and funder. If you're currently in the role of PI, sponsor, or funder of a non-commercial trial, this is your chance for advice and assistance. Post your questions below, and Raffaella will respond as quickly as possible.

Reply

  • Dear Raffaella,

    thanks for raising this important issue. I would like a bit of clarity. First, when we talk of research sponsors, are we also talking about granting bodies like NIH, EDCTP who are typical grant making bodies for research? Second, when we have bodies like USAID, DFID,BMGF fund research, are they classified as a different entity? Third, when we have bodies fund programs designed as operations research like GFATM, PEPFAR, SIDACTION and others, how are thy classified?

  • Dear Morenike

    Thanks for addressing this complex issue. In fact, in the regulatory language (WHO and ICH Guidelines), the sponsor is defined as “an individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a clinical trial”. Thus, guidelines and regulations do not make any distinctions between the organization "which takes responsibility for the initiation and management" and the one which provides financing. But in non-commercial research, and in North-South collaborative research, many trials are initiated and managed by the "sponsor", but financed by an "external agency". To answer your question: in practice, most granting bodies are not 'sponsors' in the GCP-meaning, because they do not take responsibility for the legal aspects/liability of the trial.

    For instance, in case of a study funded by the EDCTP, the institution that in the research consortium takes on "sponsorship", will have the ultimate legal responsibility/liability for the trial. The responsibilities of this institution (the 'sponsor') are described in EDCTP research agreements. This may be different for organisations that, differently from pure granting agencies (e.g. EDCTP, Horizon 2020, Gates etc.), do research themselves (e.g. the NIH). Thus, it is important always to check in details the contractual agreements with any external funding agencies, to check where lie the legal/liability responsibilities.

    Importantly, the ambiguity of the GCP definition may lead unexperienced sponsors, especially in the non-commercial sector, to underestimate the legal relevance of their own responsibilities, and to underestimate the importance of some research-related contractual agreements. According to an analysis of the Council in Health Research for Development (COHRED), “recent snapshot surveys of research institutions in the African and Asian regions have revealed some significant gaps in the contracting and contract management capacity in these regions”. The major challenges identified by COHRED include the negotiation on the overheads, the supply of IMPs, the transfer and sharing of trials’ data and samples, and the policy insurance contract. In our experience, most of these challenges are common to academic research institutions in affluent countries.

    The COHRED document (Where there is no lawyer: Guidance for fairer contract negotiation in collaborative research partnerships) is very interesting in that provide guidance for research sponsors. It may be accessed at http://www.cohred.org/wp-content/uploads/2012/04/Fair-Research-Contracting-Guidance-Booklet-e-version.pdf

    Raffaella

  • Thanks for the excellent effort at clarifying my questions. Of course, it raises other issues related to contractual agreements and what are obligations of all parties conducting clinical trials especially when it comes to North-South partnerships.

    I will be back with any further questions. Thanks once again

  • aakeneckjerome Ambanibe Jerome 25 Jan 2016

    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.

  • Dear Jerome,

    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!

    Raffaella

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