GPP scalability / relevance by study size or phase

<span class=”Apple-style-span”>I agree with Phumeza and Jessica’s statement that, GPP implementation  do not requires trial phase or participation number but GPP is relevant for every trial at every phase.</span>

In my opinion GPP should be in mind of any researcher when trying to start a trial no matter how small the expected population may be. At the planning, implementing, scaling down stage and even at conclusion GPP should be in place .

GPP should run with the life span of the project. Scaling up GPP should come from gap found from project monitoring and the need to expand the engagement scope. Mark, it is also possible to scale down your GPP when relevance challenges have been successfully addressed in the course of your project.

I agree with the fact that GPP should be an ongoing process, from the beginning to the end of a trial.

Updates on the trial is necessary to make use of what is actually relevant at each phase.

Hi Mark

In my opinion GPP implementation its not according to trial phase or number required. It is very important to follow all the principles.

Hi! Mark

there is no limit as to how many participants should consider in using the GPP, it applies across the board because we talk about human lives which need to be looked from perspective of justice, benefice and risk. so we need to apply GPP because the CAG needs to be informed and they will be linking relevant section of society where the trial will have major impact. we don’t only get negative rumours with big trials even with trials that are small can be considered.

Thanks
Lucky

In my opinion GPP is not something that is associated with a single trial or study phase. it is something that is part of the way the research center operates. Engagement is something that is continues, it has periods of ebb and flow but is a constant interaction between the site and stakeholders. This could be small interactions like a quarterly newsletter to sporadic research literacy training between trials.

GPP is relevant for every trial at every phase.

Dear Colleague, thanks for this question . In my concise thought , GPP does not limit its self to any trial size or phase. GPP should be an ongoing process from the Initial phase, Intensive phase and conclusive phase of a research. GPP should not only be in principle but should be an entrenched process in a trial size or location.

I don’t think that should be a limitation to the time or process as it were. In my opinion GPP scalability is like ICF process. Its on going. As long as stakeholders are informed of the trial well enough to allow for interaction. Any sponsor who is serious about their research would at least make sure that time and resources are allocated to GPP in the early phases of the protocol development. I also feel that the IRB or REC’s have a responsibility to know if there is going to be any stakeholder engagement prior to the protocol being approved,