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Pro-active and informative measures are the key to preventing these types of things from happening. Night club owners and other stakeholders could have been invited for a meeting at the site where information and education was provided. As such, these people would have been aware this type of trial was coming up and they could have been given information, tips and tricks how to deal with violence or stigma when (potential) subjects would enter their club or would be attacked on the streets or in the community.
At the same time, these stakeholders could have shared their experience and insights on how to prevent and limit stigma for potential subjects. By working together, a plan could have been established so all parties are aware and are capable to react rapidly and efficiently when something would happen.05/18/2016 at 1:05 pm in reply to: Lesson 6: discussion question (post here for credit) #5083
First of all, the trick is to send a draft (not final) protocol to a trial site for review and feed-back.
I would ask the site to review it first based on their knowledge and experience from other (similar) trials. If there is anything new and not explored in previous trials, I would ask the site to consult with community stakeholders to 1) inform the community about the upcoming study and planned design and 2) ask their FB and comments/concerns/questions.
After the site has consolidated this information from all different angles, I would ask to return to the sponsor so the protocol can be finalized benefiting from all stakeholder FB.
Obviously, if the protocol had been finalized and comments/FB still needs to be addressed, an amendment is due. We have experienced this before – with long turnaround times as the consequence for review and approvals.05/04/2016 at 3:17 pm in reply to: Lesson 5: discussion question (post here for credit) #4972
In one of our trials, several sites approached students and young population via social media and local online communities to educate them on our study that was coming up and for which recruitment had started. In close collaboration with the sponsor, new informative and educational recruitment materials were developed – with the major intent to educate the young population on the trial and take away any potential concerns or prejudice on the research that would be conducted.
If we compare with the traditional way of informing and developing materials, this social media “education” was very beneficial for these sites. They did attract more students and young population. We also developed a FAQ document based on all the questions and answers that were shared between the students/young population and the site staff so that other sites could use information.
Close FU will now be needed to evaluate whether this effort of broad education will also be reflected in protocol compliance and visit adherence. We have also developed a Social Impact Questionnaire so that the site can identify and pro-actively work on any other issue or concern that might happen/come up during the trial.04/29/2016 at 9:14 am in reply to: Lesson 4: discussion question (post here for credit) #4931
In our past and current trials, we mainly reached out to the sites – as stakeholders – in a pro-active manner to get their input and buy-in on the development and set-up of the study.
We have minimal experience where the site gave us input on involving and engaging additional community advisory boards. So the type of engagement and the identification of the correct stakeholder/public was done by the site.
From a sponsor perspective, we do not have experience in making a thorough exercise on the selection, comparison and identification of external stakeholders. Moving forward, we will build in steps in our process to pro-actively create stakeholder identification and engagement plans.04/19/2016 at 1:21 pm in reply to: Lesson 3: discussion question (post here for credit) #4813
In a previous study, we – together with the site, who identified and had the contacts from/with the local communities, organized an informal meeting with some CAB members. Looking back, this meeting was very useful, informative but quite late in the project. Moving on, for future studies, we could involve community stakeholders much earlier in the process so that
04/12/2016 at 1:22 pm in reply to: Lesson 2: discussion question (post here for credit) #4736
- their FB and input can be used to form or shape the trial
- more and very efficient outreach activities can be organized – again in close partnership with the clinical sites who have the most valuable contacts and knowledge about the community stakeholders.
During the set-up of one of our studies, we organized a CAB meeting with the known (at least known by the site) CAB representatives of one of our selected sites. The organization of the meeting was done by the site – as they had the contacts and were in the position to organize such meeting (which took place at the site). As a sponsor we did not have a lot of experience yet with interacting with CAB’s and local external stakeholders. Even though the meeting was organized by the site from a logistical point of view, the sponsor took the lead in providing the information and leading the discussions. Looking back, that meeting was quite successful. Not only are the site relationships with that site quite good and more informal, recruitment, quality and performance is slightly better than compared to sites in the same region. While – most probably – also additional reasons are at the basis of this difference, I tend to think that organizing this CAB meeting at this particular place, and with that the direct involvement of local subject population representatives, lead to a more thorough understanding of the site/patient relationship, better management of expectations and ultimately collaboration.04/05/2016 at 2:44 pm in reply to: Lesson 1: discussion question (post here for course credit) #4637
In our company, the principles and the importance of GPP is known but not widespread throughout the organization. The intention is that several people follow this course, act as ambassador for GPP within the organization and implement (some of) these principles within our processes and workflows. As such, I am very excited to learn more about GPP. 🙂