How GPP involve in phase IV study?

[Patchara]

In GPP; Post-trial access to trial products or procedures, most of all we talk about access of product after completed of trial. I wondered on phase IV. The phase IV is post marketing study. Do you think GPP should involve in the phase IV and how to involve?

Topic

[Jauhara Nanyondo]

Patchara  in the phase four we still need the GPP guidlines, like Jessica has said it is quite challenging on how to engage the stakeholders at this level. However what we must know that at this level the number of  key stakeholders has increased. Governments at this level should be involved because implications related to policy issues are mostly likely required at this level.

Discussions regarding the provision of the approved medical product are at this level, debates regarding the cost effectiveness and uptake are hers. Advocacy at this level is increased to increase buy-in of important stakeholders.

[Anonymous]

This is an excellent point!  What happens during these post-marketing, scale-up studies? Yes, GPP should be a part of this phase but HOW it is applied can be difficult. We are just starting to explore these issues as we watch the world begin to uptake PrEP. PrEP in the US for instance has been FDA approved since 2012. It is being accessed differently by women and men according to prescription data collected by Gilead, the drug manufacturer. There has been many oped pieces that discuss access disparities between different racial groups. GPP can play a role in engaging communities about access issues, information barriers or provider issues. The role of GPP is never to persuade communities to uptake or accept PrEP but to engage with the system implementing PrEP.

The most pressing challenge would be how to frame the central relationship. In research, it is between the research team and a variety of stakeholders. This might not be the case in Phase IV. There may be many different interactions that happen at the same time.

How would others implement GPP in the scale-up phase? 

 

[Leader Kanyiki Ngooyi]

If I understand the concern, it is about the relevance of GPP in phase IV processes? I do believe that GPP is designed to assist in all the stages of a clinical trial for as long as there will be a need to enroll participants, to engage community and other stakeholders and so on. we all seen clearly how a well planned GPP plan may help avert a lot pressures, tensions and difficulties around a given trial.

It’s about how you design your plan to fit your target groups and the objectives of your particular trial I think?

[Author]

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