Treatment of study particpants and GPP implementation

[Charles]

How do you implement GPP when you have received the final version of a protocol recruiting young children who are promised care and treatment while on their study but the mothers bringing the children are excluded?

Topic

[Erica]

Hi Charles, our site is similar to yours, in most cases we receive protocols in final stage very rarely the stakeholder/site have a room to make minor changes in the Site Specific Addendum where the trial is multi-sited. Responding to the situation about mothers being excluded, I guess here is where the higher levels in health such as Ministry of Health or Department of health   or any other authority  depending on the set up in your country, should intervene and  discuss with  sponsors and if necessary make it one of the necessary requirement for that study to be conducted in your area.

[Charles]

Jessica  I appreciate your input that stakeholder engagement is not limited to time but an ongoing,  “live” process. Now the final protocol is with you it has gone through you regulatory process and ready for recruitment. The challenge this poses is that the mother brings this participant to study ques for the process. The mother then goes to another health care provider for her medical attention.

Now because the protocol only provided a budget for treatment of participants for study related harms/injuries and minor ailments, upon consultation can stakeholders require that mothers too should be treated and ask the sponsor to review the budget? How can this be enforced to comply with GPP?

[Hilda]

I agree with Nokulunga, before the protocol is finalised, it is indeed the responsibility of the research team to show the draft to the stakeholders in order to come to the agreements with the input of the community, changes are acceptable and made to adapt the site and the people who live in it.  Only after the stakeholders have been consulted and agreed, then a go ahead to finalise will be done.

[Nokulunga]

According to my understanding before the protocol is finalised, research teams receive a draft and that draft is used by the research teams to ensure that a range of stakeholders give their input on how the protocol is designed and voice out their concerns and what is unacceptable and acceptable in the community. Trial sponsors only send a final version of the protocol once research teams together with stakeholders are satisfied or have made changes where applicable and that’s a protocol development process.  I think in such scenarios maybe a protocol can be amended.

[Steven]

If you receive a protocol, i feel there is still a need to call for a stakeholders review so that they give their thoughts about the protocol. Feedback should be sent to the protocol team so that they know what the stakeholders think about the protocol. The stakeholders will also help to come up with ways on how to better communicate with the communities and also how to deal with issues when they arise during the conduct of the study.

[Anonymous]

Charles- Are you asking the best way to get stakeholder input or if GPP can be implemented now that stakeholder review of the protocol isn’t possible?

In an attempt to answer the question i would just remind everyone that GPP is a framework that applies to a process. If one part doesn’t go well, it doesn’t always bring the entire system down. If stakeholders don’t have a chance to comment on a protocol GPP can still be implemented in other areas. Stakeholders can still be shown the protocol. They can still be involved in the plans to develop materials, create a communication and issues management plan.

I’d love to hear others thoughts!

[Author]

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