[Evelien]

we try to have regular contact with the investigator and request their input via questionnaires after completion of each phase. with this kind of lessons learned, we hope to optimize collaboration. They also have the option to feedback and come back in case of (potential) issues. I think on a day to day basis, it is very important to keep communication lines open even if the discussed issues are sensitive or negative.

we still have a lot of potential to progress as we should have a kind of standardization. this “standardization” will be based on developing new/updated processes and documents but also just get to know each other better so we can use each others knowledge in reaching the similar goal.

[Evelien]

1/ proactive communication with support groups/representatives and club owners: this should have insight in expected vulnerabilities within the trial protocol so changes could be made. Also best preferred communication could have been discussed as these groups have experience in what are the topics that are usually “attacked”.

2/ proactive  and regular open communication via social media and journals should have been foreseen providing all available information on the content and goal of the trial. Even if rumors are started, full information is available when needed and can be used to contradict the rumors.

3/ issue management plan should have been in place (tackling different items as marketing/advertisement around the club involved (and other places that are receiving MSM people), over how and to whom to escalate if a situation gets out of hand, to how to ensure physical safety of people coming to the club (“rescue plan with hospital/medics in the neighborhood), psychological and social support of people/providing contact person if things get out of hand and people are being stigmatized.

4/ forsee a network of legal support for people that are getting stigmatized and in trouble with legal department due to trial participation (can go from defense of the subject legal rights over avoiding unemployment due to participation and risk of insurance problems, …)

[Evelien]

if the protocol is already final, you cannot really proactively address GPP guidelines. You can only take corrective actions which will result in an amendment. as submission and approval timelines are quiet high , it should be considered to add in review by site/country level at an earlier timepoint as it provides valuable information. the opportunity to provide site level feedback should be build into the current company workpaths so they become a more standardized approach. I also think that when local level input becomes more standardized, it will improve overall study start up timelines as general concerns and lessons learned , known from a previous protocol, will find its way into the new protocol under review. It will also add to the expertise within the company and better site relationships. The only tricky item, as always, is where to put the line implementing the suggested changes.

[Evelien]

 

Some sites have used social media and journalist (advertisements, posters, …) during recruitment phase to get the message out. I have not seen real broad implementation of social media and online communication to be used in further trial set up. Perhaps it is an idea to use it during communication of the primary analysis results (that will be known in Q3 2016) and as long term retention strategy. I will put this on the table.

In our trial a lot of the input has been given via face to face discussions. Investigators also sat together with the MD to really discuss potential issues that could arise at their specific sites and how they manage these normally. Where possible, presentations were adapted last minute (with successful outcome). I think this could be taken up more broadly in developing standard templates that then can be shared with all sites/subjects, this on paper and online. We should have a plan in place that deals with these issues proactively, ready at study start. Also really building up a strong GPP network will be helpfull as information and good practices will be shared earlier.

My direct concerns are:

• does sponsor has IT solutions available and will there be sufficient budget for it?
• do participating sites have sufficient IT available or does communication preferably is shared in paper or both (depending on the person it needs to reach).
•  time constraints. this new field is developing so quickly within the organization that it is hard to meet trial/program deadlines leaving not a lot of time to really build structural solutions. i know the organization is committing to implement GPP and perhaps higher level implementation is already ongoing but still needs to be deployed…

[Evelien]

you analyse what were the strong and the week points of your trial via self analysis (“lessons learned sessions”) or surveys for stakeholders.
==> some will lead to internal issues that need resolving (resource availability, IMP availability, process flows, workload)…
==> some will lead to external issues that need support (training of teams, communication plans, providing sufficient and correct/needed information, …)

you then link them to your goals (improve stakeholder relationships, improve conduct of trial to get IMP to the subjects who need it earlier, …). If you end up with a lot of issues, you determine which ones crossed the critical path or gave the most “negative impact” on the trial and stakeholders.

this way of structural working will provide a priority list of topics that need to be handled. Once these are chosen you see if you have the correct representatives on the table to really do a thorough in-depth conversation around the defined topic. These are mainly people who have a lot of expertise in the field, have large networks on different levels, can really take your question back “to the field” and provide you with the necessary answers. In order to have a satisfactory feeling in the end, it is very important that all participants know what is expected from them and what you can/cannot offer in return. It needs to be clear that you are working on a short term and long term investment in order not to loose them in the end.

[Evelien]

Hi, I know that we as a sponsor did not reach out (pro)actively to community stakeholders but we know that our sites have indeed reached out to community groups at time of recruitment period (was part of their recruitment plan). Some of the sites also have a site set up that provide the opportunity for the subjects to interact and come together at certain time points, not linked to the protocol, but linked to the clinic itself. I have not yet looked into the fact to see if indeed these sites do have a better retention percentage (as retention is becoming our next hurdle as it seems).
The sponsor did reach out to the study staff to take their input into account with regards to INC/EXCL criteria, trial procedures, … and adapted the protocol set up if needed.
I think I can conclude that the formative research was done on “theoretical protocol content level” but not really on the “practical trial implementation” level. For the latest point, we completely relied on site level.

[Evelien]

When we run into problem with submission and approval process for our IMP to an authority, while that IMP was linked to the endpoints of a primary analysis (from which the outcome determines our protocol completion but also the set up of all trials using that compound). Due to the criticality of the shipment, a lot of pressure was put on different levels leading to a lot of frustration, a lot of miscommunication / minimal communication from some parties what in it’s own term worsened the situation as it was no clear how to proceed and how to get out of the web and get things moving. In the end the local people were involved at several levels and they received the necessary information using their internal networks. their support really weighted in the resolution of the problem and it has been acknowledged that we should ask for their support more and keep them more up to date so issues do not escalate to that level anymore. Although the intention to involve local levels better and more open now, it remains difficult to determine when to escalate as all parties do not want to receive more than needed information (due to the high internal workload at all parties).

[Evelien]

There is not much experience within the sponsor team with the GPP principles. Only 1 colleague really received training (and has recommended it to complete team). Although we have tried to reach out to the stakeholders it most often has caused some “side effects” as the communication was started too late whereby you always end up in a stressful situation. and stress if of course not contributing to open communication, and good site relationship.
If I look objectively to the current trial, one major item is popping up. The set up should have used a more proactive approach, taking into account the different aspects , partners and stakeholder groups together with all their (linked) processes. I think that our current trial really encounters every possible hurdle but we made it so far. although working with a lot of different parties in a relatively new research field, caused a lot of unforeseen delays, I also think that the potential learning curve is big and exciting. and I really appreciate the patience of all our stakeholders because although there were high stress periods, they stuck by our side and we are moving ahead. I really do hope that for future trials, time is taken to really implement the lessons learned and to engage with all parties in a pro-active way.

[Evelien]

Hi everyone,

I am Evelien van den Broecke, living in Belgium. Since a year I transitioned in the role of junior global trial manager in an HIV trial but before I was a CRA working on different topics. I am looking forward to learning new things (as GPP is completely new for me). The most I look forward to share ideas/opinions with all of you as it is always gets very beneficial and interesting when people with different backgrounds come together to discuss one and the same topic 🙂

Best regards, Evelien

[Author]

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