-
Topic
-
-
Replies
-
-
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.
-
It’s good and helpful to read the other posts because we are relatively early in our trial plans. previously with our pre-trial research studies, we’ve always tried to engage stakeholders in the development of research idea, send drafts of the research proposal at various stages to get feedback. What I’ve found interesting is how to get the most feedback from community stakeholders. In some cases, if we just send a whole proposal and as for feedback, we might not really get anything, and it would be good to have face-to-face meetings where researchers could summarize the key steps of the research to get feedback. in other cases, when we send sections or specific components of a project, for example, participant survey questions and ask for feedback, we can get really useful comments on content, language, etc.
-
Yes caroline, protocol development and review process is an opportunity for community members Reps and CAB to build their capacity HIV Research literacy and in work of the Nigeria HIV Vaccine and Microbicide Advocacy Society, we developed a simple tool outlining some key concept of HIV Research literacy in colourful, pictorial illustrations during any activity that calls for such process to help enhance GPP and full involvement of a review in a protocol for research.
-
When a protocol gets sent in final form to me, I try to review with members of the CAB, Representatives of the key target population for the trial to be ascertain the level of community engagement outlined in the protocol.
I will also try to break down explanation of the trial protocol for the CAB and representative of the Trial community for them in simple terms to understand what entails the document, process of informed consent, process of trial result dissemination, process of which standard of care package is outlined and process of addressing human rights violations too.All in the team must carefully study the document and raise questions and recommendation that will enhance good GPP and entrench it in the process of the trial and after.
-
Interesting question. When we recieve the protocol we organise a meeting with CAB members to review the protocol word by word and document all the input. The investigator will be present to answer any questions the CAB members might have and give clarity in some terms the CAB members may not be familiar with. After the protocol review the CAB members will review the informed consent and also make some comments on the content, language and other important factors. My only concern is our engagement with the broader stakeholder on the protocol review.
-
I feel it is important to come to local sites with draft protocols that are intended to receive feedback from local stakeholders.
We have just gotten through the process of getting agreement to the basic outlines of a trial protocol for our planned study among the various partners at the global level and are getting ready to have a first conversation with regulatory bodies to get their feedback. Once we get that feedback we will be moving on to sharing the general idea of the study design with other national stakeholders, potential site investigators, and communities. The lesson provided useful examples for how we could structure getting feedback — for discussions with potential site investigators we may be able to use the clinical study proposal that has already been translated; however for discussions with the community stakeholders, we will need to create lay summaries in local languages. I expect that this process will take several months.
-
I have not experienced a protocol being sent to the site as a final document – it is always in draft form to allow for input at site level. However, if this happened I would imagine that CAB members and relevant stakeholders would extensively review the protocol and the concepts that would be difficult to grasp would firstly be explained further and cautiously considered when preparing the ICFs and participant outreach materials.
Any training needs relating to the protocol content would need to be assessed in order to ensure that CAB members provide meaningful input and participation in the study, they need to be well equipped with relevant knowledge and skills.
-
We have had several studies in our site where the protocol has been received when it already finalized.What we have done in the past is to start the engagement at that level.I agree that not much can be done at that moment to inform the protocol. I also agree that this process has to change and I am happy as I write this, new studies are consulting widely.We solicitate for buy-ins from the stakeholders and note any comments and suggestions or recommendations which we relay back to the protocol origin. Sometimes this process is so fixed and definitely it cuts out the benefits of stakeholders shaping out the research process.
We have not had an instance where the protocol has been changed as a result of feedback from key stakeholders so far.
-
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.
-
-
We have experienced this at our trial site. The trial was already busy and our Research Centre joined later to reach the target of participants, so the protocol was already finalised.
We organised a protocol training for stakeholders, whereby we went step by step through the protocol and whereby stakeholders were able to ask questions or provide feedback on the trial. We’ve used their expertise for setting up a Recruitment, Adherence and Retention Plan. Obtained information was shared with the sponsor.
Community sessions were organised to share information on the trial with other relevant stakeholders to gain support for the study.
We’re looking forward to set-up a session with stakeholders in the future to discuss a new protocol as explained in the GPP module of this week.
-
Excellent line by Anthonia, there must be an amendment to any protocol before and while implementing so nothing like final form. I agree with this statement, protocol development is ongoing process and changes may occurs if issues/ question will be raised by both stakeholders or research team. I think protocol should be accepted, and implemented with respect to time.
We will organize meetings, workshops, public forums, and multimedia to provide opportunity for stakeholders on protocol reviews, and ask to advice on the changes in protocol developments. We will also organize consultation with civil society, and other broad stakeholders at global, regional, national level to obtain the focus input on protocol developments. We will also provide opportunity to local stakeholders to trial design issues and procedures, trial objectives, recruitment strategies, informed consent materials and procedures, reimbursement policies, counseling approaches, follow up procedures, and post trial access to trial products and procedures.
-
This is certainly something that is a challenge – buy in has to be gained from stakeholders to ensure the protocol is accepted and implemented. Whilst we will have engaged with the high level stakeholders prior to protocol development, we need to seriously consider how to better this within our setting. I am reading through the above comments to get practical ideas!
-
I think this is a very long process. We recently had one protocol sent to us on Salmonella vaccine trial But the protocol is envisaged for implementation starting from the 4th quarter of next year, 2017 after the following have been met. Selection of 2 trial sites out of the 5 sites that met trail requirements, protocol amendment on participant selection, informed consent and areas of re-imbursement and detail report on stakeholders engagement.. We have also responded by telling the PI of the need to get ethical approval for the proposal and register the investigation product (i.e vaccine).
-
-
Thank you for the question, if the protocol is sent to site, it gets reviewed by the CAB first. Broader stakeholders get a chance of reviewing it as a matter of information. The targeted population gets to have a view on the protocol, and their comments and recommendations are solicited to the final version. This happens through representatives of the population. The protocol and informed consents are reviewed separately, to get opinions especially on informed consents. It is much easier to review consent forms separately because if they are in the protocol, it is not very practical to exhaust the documents.
-
I would like to reflect on the email that was sent:
- How much time and investment do you allocate for research literacy activities if the CAB or community members do not have sufficient experience with clinical research? Our site invests a fair amount of time in educating CAB members and other community organizations/ stakeholders on clinical research. We provide CAB specific trainings and do community presentations regarding clinical research often.
- Do your engagement staff understand the basic science of HIV prevention research, trial procedures and participant protections and are they familiar enough with the trial protocol to accurately explain the research methods to external stakeholders? The engagement staff is mainly me, but our clinicians and investigators often do presentations and education. Yes, we are all knowledgeable about the research to explain it fully to outside stakeholders. Sometimes, I have to help the investigators speak less technically out in the community, but we usually have no problem.
- How can your literacy program be strengthened or diversified (even without additional resources)? I think that making sure the material is current, relevant and easily accessible is the best way to strengthen the literacy program.
-
Our site reviews protocols with stakeholder 2 different ways (2 networks). For ACTG protocols, a CAB protocol draft and lay summary is sent and reviewed by our CAN. Our PI goes over protocol with CAB and asks for input. Everyone turns in a questionnaire to the Protocol Development Team. The MTN is less formal (although they are taking steps to be more formalized) When the MTN protocol development team wants stakeholder/ community engagement, they send an email to the community working group who then gives input and also asks the CAB members what their input is. Then that information is conveyed to the protocol development team.
-
When a protocol is sent to our research team, with some key stakeholders we go through it page by page and line by line then we make changes by removing or adding in a way it will suit our population. Our community stakeholders will also go through and understand the contents.
We do not see any protocol sent to us in a final stage we always make an input and there must be an amendment to any protocol before and while implementing so nothing like final form.
-
This is an interesting question. The primary method is to adapt the informed consent to local regulatory needs and based on historical wisdom, then circulate it to the community advisory board with a solicitation for feedback. This is done with a real commitment to hearing that feedback and making changes whenever appropriate and possible.
In addition, it is hoped that the community stakeholders understand that no protocol is ever *really* in final form in the sense that ancillary documents, memos, and even protocol revisions can and do occur when circumstance warrant and dictate the need. This could happen for any of the reasons related to community and contextual realities such as feasibility, relevance, and acceptability as discussed in the lesson but it could also occur in the face of study enrollment that is poorer (or in rare cases better) than anticipated.
On the other hand, the real work of stakeholder involvement occurs prior to the stage via the solicitation of experienced community stakeholders to serve on the protocol team and on working groups, via the conduct of forums and stakeholder meetings at the regional, national, and global level, etc.
-
Before sharing the protocol with stakeholders of the community, be must ensure they have the enough knowledge and necessary training on research process and also on the topic of the protocol which will be asked for their reviewing. In this way it will enrich the contributions they will give us about the protocol.
After ensure such skills, it will call a meeting with stakeholders to present the protocol to review and through a moderator receive the contributions and suggestions of stakeholders about the presentation, it should be noted these contributions should be accompanied by an argument or fundament that highlight the importance of the changes to be carried out.
Unfortunatly, that I exposed before is something I have not been able to experience directly because as I said before in my office we do not have at this moment a CAB which complies with all the requirements for a the reviewing of protocols. -
-
Caroline and others— do you also use the protocol development and review processes as opportunities to ensure that the science is comprehensible to everyone —if something in the protocol is not clear, then everyone benefits from having community members who speak up with questions. This can even feed into and strengthen key messages about the trial!
-
- The forum ‘GPP Online Course Forum_March 2016’ is closed to new topics and replies.
