Clinical Trials: engaging with the right sites from the start and how to assess sites’ capabilities.
Assessing African clinical sites for involvement in clinical trials is really no different from assessing them anywhere else in the world, the main questions being:
- What staff and with what experience?
- Does the site have the right infrastructure?
- What are the local regulations and requirements to obtain approvals to start a clinical trial?
- What logistic hurdles are faced for getting any trial supplies or data in and out?
- What therapeutic area is their expertise and how many patients do they have access to?
But then I hear you say but Africa is different! Yes, it is, but no different to looking at China vs US sites or Poland vs Australia or many others. As we have gradually looked at involving sites from around the world over the last 30 years to help us increase speed of recruitment and market awareness, we have learnt the different needs of each location. It doesn’t stand still, all the time processes are evolving and regulations are being refined or refreshed. Therefore, it’s our job in the drug development arena to work with all the healthcare professionals who are committed to helping pharma companies bring new medicines to market through engagement in clinical trials.
The most important thing is that we are diligent and thorough in assessing a sites capabilities, that we take the time necessary to develop a relationship, that means the time and commitment is there when a suitable trial comes along. It’s critical to recognise the cultural differences – don’t make them a barrier but work with the staff at the site to assure a common understanding. I learnt very quickly that the high level of enthusiasm meant that it was important for my African professionals not to be seen to be missing any requests or timelines, and rather than say something has been delayed they will wait until they are able to send it. Whereas, I am more comfortable with being informed about a potential delay and a new timeline. So, we have worked to understand why something is important to know in advance… and if it really isn’t I don’t lose sleep over it!
The most important part of any trial is in the set-up phase – take time to get the right sites in the right locations with the right patients and then with a sound protocol and data reporting process a successful trial will result, giving data you can rely on to decide the next step in the development for this drug.
What I have learnt in the time I have been engaging with Sub-Saharan African sites is that they are keen to be involved, happy to put in time and effort to meet the standards required for joining global commercial trials and have a wealth of experience in research. However, it’s not all plain sailing and it’s really important to evaluate in detail and ask the questions in the right way to ensure the sites capabilities are not only recorded but fully assessed.
So, here at eMQT, what do we do?
We start by using our capability assessment tool ATOM which provides a platform for recording all the key aspects of a site from ethics timelines to number of MRI machines to IMP storage location. Having all this information in one place enables us to search, analyse and report on any particular area and most importantly do a gap analysis by site.
We ask the right questions and clarify the answers. Ideally, we like to do this in a conversation face to face and where this happens, we don’t rely on what we hear but also what we see. We always take a video of the site facilities when present but it is still important to ask the right questions. Let me give you an example….
For those working in communicable diseases a lab test confirming diagnosis is the norm. What equipment do you have we ask? The most modern of machines for this task we are told. Excellent news as that is state of the art. However, what we should ask is what equipment do you use? It is not uncommon in African sites that they have very new and modern equipment, maybe donated or acquired through a grant from a major foundation or charity. The problem is these “donations” don’t cover ongoing consumables and the machine is left idle as these specialist reagents are too expensive for their budgets.
So, think about the questions posed. We like to do our initial capability assessment as a personal meeting but at least as a video call if being on site is not feasible. I would certainly not advocate a standard questionnaire sent via email as you get the answers, they want you to know not necessarily the detail and nuances you can tease out in a face-to-face discussion. But then that’s not so very different to new sites anywhere.
The most challenging questions when assessing site capabilities is always around the number of patients they see and the numbers with a particular condition that attend their clinics. Don’t be shocked and think it’s an error if you see number 10x what you have experienced before.
Two examples we have seen is one for sickle cell disease where the clinic we were visiting had 200 patients queuing for their clinic visit when we arrived before 9 in the morning, and they have the same size clinic list every day!
Secondly, in a town diabetes clinic, we asked for the number of patients they see and the answer … 4000, this was not an error. This primary treatment site has the data for all 4000 patients that they see. It really is a different magnitude, and of course if a trial was run at the site this would bring its own logistical problems, but that’s not for discussion here.
When a member of the eMQT team finishes the assessment, what happens next. Well, first all the data is uploaded into ATOM and then a full gap analysis is performed. From here we look at what the gaps are before we would see this site as a Centre of Excellence for commercial clinical trials. Once we know that we then work with the sites to support them in filling these gaps – be it training or advice for internal processes.
Overall, we find that sites are extremely capable, they often have senior staff who trained in countries like USA, UK, Germany, France for example, they have experience of global commercial trials from that time and most importantly they are hungry to be involved. The most important thing of all is to give their patients access to medicines and potential new therapies that are currently way beyond their reach.
And I agree with them, bringing the miracle of new treatments to patients is why I do this too.
Dr Tina Barton
Interested in learning more about our site capability assessment tool? Contact us
Dr Tina Barton has over 40 years’ experience in clinical research and the drug development arena, working with major Pharma companies and their clinical development partners. Bringing a wealth of experience from strategic business acumen, change management and process enhancement with a proven track record in driving growth and training for the future. Dr Barton is now focused on bringing the miracle of new medicines to patients in Sub-Saharan Africa through engagement in drug development projects, bridging the gap between African sites and pharmaceutical companies.