IBCD 2016 - Innovation and biomarkers in cancer drug development
Screening Patients for Efficient Clinical Trial Access (SPECTA)
Dr Vassilis Golfinopoulos - EORTC, Brussels, Belgium
What we had in SPECTA was that we tried to build a screening platform, which we built finally, screening patients for entering clinical trials but what we saw and everybody else has seen is that the number of patients actually ending up in a clinical trial was so small that the whole effort, the whole investment is quite hard to justify. So the next step was to find a way to increase our… return of investment is a financial term but a return in terms of research results, how much we can get more patients into that. For SPECTA we had two ideas, one is to tailor screening to patients that already had a good opportunity to get into clinical trials, so offer efficient gains, and the second is to use the whole infrastructure which was built with a big effort to be as quality controlled and try to introduce as little bias as possible into the whole of the EORTC infrastructure. So today all our translational research from clinical trials that are not associated with SPECTA go through SPECTA to use the same infrastructure to make sure that the results are better quality, reusable and stored in a harmonious way so we can work with collaborators among our own.
What were the common issues among clinicians? Recruiting issues or storing data?
It’s both. We’re past the learning phase in how we need to collect tissue, store tissue, analyse that and store the data. Indeed, we had already problems but now everybody is doing that in a pretty good way. The debate on decentralisation versus centralisation is mostly over, we know that we cannot decentralise this too much if we want to have robust results, at least in a research setting; in healthcare it has to be decentralised. And debate is now on the essence of how much the current situation in personalised medicine is good enough to bring results to the whole patient population, not to just very, very limited subgroups that are just lucky enough, I would say, to have the alteration and get the correct drug.
How do you feel about the regulatory problems facing clinical development?
It is obvious for everybody that regulators are part of the system so they are part both of the problem and the solution. I don’t think they should play such a big role as everybody is telling them to play. At the end I actually sympathise with them, they have to do a job and evaluate the evidence and make sure that they give a robust answer that is as correct as possible. It is the case that with all these new drugs the level of evidence is less than the level of evidence we had with traditional clinical trials. On the other hand, everybody recognises that it is less and will remain less, there’s no way we will build these big clinical trials again with so many drugs. So, yes, the regulators are working on it, they have not done much, I admit that, they’re trying to get closer to what the healthcare market needs and the patient needs. I don’t expect them to be as flexible as to completely overhaul the whole situation.
Can you tell us about the discussions arising around the clinical deployment of personalised medicine?
It’s both a useful and useless debate. It’s useful in the sense that we need to continuously reassess where we stand and what we are doing; it’s slightly useless in the sense that it’s going so fast and we are going through a phase that everything changes so fast that we know, as in everything that happens in the world, it will take some time to settle down. So trying to predict the future in a situation that’s changing daily is a bit futile. We need to know what we’re trying to do and where we are going but, like everything, this is very much technology driven and we know that every technology passes through the phase of hype, of the huge hope, then it’s the phase of disillusionment and then it settles somewhere. So we are somewhere in there, I suspect we’re a bit in a disillusionment phase, but it will settle out in a higher level.
How have you found the IBCD conference to be?
The conference was much better than expected, I must say. It’s the right size, we have seen many times going to conferences that are huge, there’s not much that can be done there. It’s not as small to be considered a workshop, it’s not as big so that nobody can participate. I’m happy to say that the mix and the level of speakers was the correct one – there were regulators, there were pharma, there were diagnostics, there were academics, there were patient representatives. No, it was a good
