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This course reinforces how essential and effective GPP can be. I was at a workshop for clinical trials design for emerging infectious diseases (ebola virus preventive vaccine trials) earlier this week and the recurrent theme that was discussed was the importance of communicaiton with different stakeholders and how without this, none of these trials could have been successfully implemented. The concentric circle of stakeholders was even mentioned! Go GPP!
Sustaining relationships when resources are limited.
This is where one has to really ‘dig in’ and mobilize the good will of the community. One of the best sources are volunteers in previous trials. I suspect they would be very willing to help spread the appropriate message. When you mention leveraging partnerships and exisitng forums, I also think of other diseases (e.g., TB, malaria), where one could turn to partners involved with these trials to get their help and to also discuss the message that the impact of that diseae may have on HIV (and thus the need for HIV prevention).
Communication with MSM stakeholder groups would be essential before intiating any part of the trial. This could have helped map out potential problems and brainstorm ways to avoid or alleviat these.
If possible, discussion with more formals agencies (e.g., police, legal representatives) may help in planning for any potential issues.
RE — access to higher standards of prevention/care than other members of local communities
This can indeed be a very trick question. Culture and political will can be very strong, but education at all levels can help bring a new level of understanding to stakeholders. In all cases the minium standard of care needs to be enforced, but in cases where there are newer/more advanced options/standard of care it is important bring this information to the stakeholders so that it can openly and honestly discussed. Change may not be immediate, but it beholden upon the trial team to be involved with the advancement of care.
My colleagues remarks are very informative. It seems that it can often be a challenge to get input from the stakeholders in a timely way to incorporate into a near final/final protocol. I wonder if it is possible to have some common elements of protocols routinely reviewed so that when trial-specific elelments come along, the focus can be on what is unique to that protocol and it impact on the stakeholder.
Social media and online communication are key elements in some US trials, beginning with recruitment through trial completion. The benefit is to be able to discuss information clearly and thoroughly in a way to minimize misinterpretation. On the other side, responses may need to be almost immediate, which an cause a challenge.
Stakeholder engagement is defined in the GPP document as, “…processes through which trial funders, sponsors, and implementers build transparent, meaningful, collaborative, and mutually beneficial relationships with interested or affected individuals, groups of individuals, or organizations, with the ultimate goal of shaping research collectively.” Formative research can be regarded as one form of community engagement (a subset). Of note, formative research would be one of the first steps in community engagement and lay the foundation for engagement and open and trusting relationships.
I cannot directly answer this question as I am not currently a staff member executing clinical trials. However, from a Sponsor perspective, one of the most important things to do is make sure those involved with trial development are aware of the importance of formative research and encourage and help facilitate this work.
