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From a sponsor perspective the most important stakeholder is probably the site. But besides that I would follow the blueprint, and select based on the importance, influence, interest and interest of the stakeholder. I agree with the previous comments that this is not an easy task, as each of them have specialties. I think one should act very cautiously in the selection process as there may also be a political aspect involved. By ruling our a less ‘important’ stakeholder now, they may not be interested the next time when you do need them. again, each stakeholder represents a different group/background/thinking so the order also depends on the goal you want to achieve.
I have little experience in involving community stakeholders in formative research, but if I would start formative research I would certainly involve them. Start with some internet and literature searching and than find community stakeholders, and start talking to them and from there learn and expand the list of community stakeholders who are relevant for my research. ask them about local issues, how to best approach potential study volunteers, how to reimburse them within the legal framework, other expectations, the list is endless. Formative research is were it start and cannot be done without community stakeholders.
In our HIV clinical vaccine trials most of the time we use well experienced sites, who have already done the formative research and have mapped out everything, at least that is what I expect from them. I don’t see myself going to an area and set up a get together with local stakeholders, not that I don’t want to. So please let me know what sites and other stakeholders expect from the sponsor (except budget).
Now we go to a site or network and ask them if the study is feasible and how many subjects the site can recruit and in how many months. Everything else is done by the site. I really would like to be involved more but don’t know how (not yet).
As mentioned, I have no real experience with stakeholders engagement, but there is one thing I can remember that comes close, and happened in my previous job, that was when I forgot to agree with the investigators who was going to be the main author of the publication and who else were going to be mentioned as author and in what order. I assumed wrongly that this was not going to be a problem, being all professionals. The moment the article was going to be published 5 out 9 of the investigators found that they should be mentioned first. But the real trouble started after I had to tell them that only 5 investigators could be mentioned as authors, as instructed by my manager.
All most likely could have been avoided when I, at the beginning of the trial, engaged with all the stakeholders (investigators) and came to an agreement of whom and what regarding authorship.
Until very recently I have never heard of GPP before, GCP and GMP yes, but not GPP. Maybe that is why I was asked to join a working group that is reviewing how to implement GPP first in the vaccine HIV clinical research department and later maybe cross company. However I have a lot of colleagues who do know (a lot) of GPP, some in my team. I work for a sponsor and we want to accomplish to implement GPP by providing sponsor specific guidelines to first raise awareness and facilitate the implementation of GPP in our (sponsor) organization, as we have a slightly different view on GPP as other stakeholder may have, from a financial point of view but also from ethical and pragmatic point of views.
So when I get this right the biometric fingerprint can be linked to several studies. is this limited to only one network or can this system be used cross country. Are the fingerprints stored for cross networks?
Hi All, My name is Richard de Rooij, I’m Dutch, meaning I’m from the Netherlands. I’m a MD, and I’m working in the vaccine development since 2009. In Sep 2015 I joined the HIV vaccine clinical development team in Janssen. I’m based in Leiden, and I live in the Hague. In my role as medical lead I’m co-responsible for the clinical development plan, the design and conduct of the clinical trials and the safety of the the volunteers that participate in our trials. We have a vaccine in development, using vectors and proteins, and so far the results look promising. We closely collaborate with the NIH. Recently I was invited by AVAC to talk about our program in Brussels. Maybe some of you attended. I’m looking forward to work with you, it is exiting seeing so many people from different nationalities and background. Cheers, Richard
