Thursday, November 19, 2015

Trudie Lang on the African Ebola trial

Trudie Lang, Professor of Global Health Research at the University of Oxford, UK, was involved in running the clinical trial of the treatment  used in the Ebola outbreak in West Africa. Ian Schofield spoke to Prof Lang after her presentation at the PCT conference, and asked her about the ground-breaking trial, what the experience taught her about our preparedness for future outbreaks, and what more the industry could do.

How did you first get involved in the Ebola  trial?

I was working on the drug trial – we ran a trial platform from Oxford funded by the Wellcome Trust. I have worked in tropical medicine for the last 20 years, mainly working on malaria, worms, leishmaniasis and so on, so we are used to setting up clinical trials in vulnerable populations in resource limited settings with low capacity on the ground. Previously I worked in Africa and Asia, 
and for this we worked in Liberia and Sierra Leone.

So what happened when you first went over there to get involved on the ground?

We worked with local investigators, with Médecins sans Frontières, with their treatment centres and with local clinicians, and we had a small clinical operations team that went into the tents to work with local healthcare providers and local researchers on the ground, so there was a lot of partnership. We were the sponsor, we wrote the protocol, planned the research, and gave as much support as we could, but what we really need to think about in the future is helping countries like Sierra Leone and Liberia to be able to lead these themselves. The research capacity gap is really the key, and it's important that they have more local capacity to allow them to operate their own trials. The only way they will do that is by working on other trials and having research as a normal part of operations in those countries, where now it really isn’t happening.

You mentioned the time taken to sort trial contracts out for the Ebola trial – what lessons does that hold?

Yes, we all know it takes far too long to set up any clinical trial and there are things you could do differently, contracts are always a problem, and then we were in this Ebola situation. But the same things come up – IP, time to publication, future pricing of drugs – so we should get ourselves sorted out and try to make sure we are prepared for the next time. We can have meetings with the WHO, have cross-stakeholder meetings, drop-down boxes and template contracts that we could pull off the shelf, but you know this takes work and time and resource and it is very, very difficult to get funding for this kind of research preparedness and capacity development, which is a massive gap.

Was it difficult to draw up a protocol in an on-site situation where there was a disease outbreak?

We are quite experienced in designing clinical trials to work in those settings and do quite a lot of work on being lean and agile, so I think actually the science was the easy bit. We were quite bold in our trial design and we had to work within the situation we were faced with: we couldn't do randomisation, for example – that would have been completely unethical – but we used a design that oncologists use, in that we were looking for big difference in drug effect so we could use historical controls and this was a perfectly legitimate scientific approach. But although there were big scientific challenges in terms of design of protocol, they weren’t necessarily logistical or organisational system challenges.

You mentioned it would have been easier to have access to commercial back up from industry.

I think it's more a question of commercial involvement rather than back up – they have an awful lot of expertise in running trials. I do a lot of research skills training, and I always say to people that a clinical trial is a clinical trial – most of us had never worked on an Ebola trial before and yet we were able to walk in and write a protocol and set up a trial because the skills you need to set up an Ebola trial are not really any different from oncology trials in Washington or Paris. But you need to be a trialist, and we need to be working much more in partnerships – industry has a lot to bring.

Have you been engaging with industry since this happened? Is there a forum where you can talk about this?

The WHO is writing a blueprint on what to do next time, and on the question of research readiness. I think it would be great to involve pharma more in some of this capacity development effort if there was interest, and of course these are emerging markets, so why not? Perhaps there is not the immediate commercial incentive to do so because it is not about a particular product, but it is about preparing the ground for clinical trials for a product. So should there be another outbreak and we want to test a vaccine, then it would be good to get some of this groundwork under way. So it would be interesting to work with pharma if anyone was wanting to get involved, but that might be a tall order because there is no in immediate commercial viability. But maybe some corporate social responsibility activities would be attractive to groups.

Have you learned enough from these experiences to really make a difference next time?

I think we made an enormous amount of progress, we ran trials within this outbreak and that has never been done before. We need to keep that corporate knowledge, if you like, between all the organisations and hope that we do better next time in having international leadership and so on.

Where might future outbreaks happen? 

Who knows, this is the thing isn’t it? We may well have another Ebola, a haemorrhagic fever type viral infection, a respiratory disease outbreak. There will be other outbreaks, and there will be other therapies and vaccines that will need to be evaluated, so we need to work at the global level to make sure we deal with some of these issues.

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