Anastassia, thank you very much indeed for giving us some time; a very busy meeting at Madrid. You’re from the EORTC, your name is Anastassia Negrouk, and you are pushing hard to get clinical trials easier, quicker, more patient friendly and then we’re going to get the answers to all these new targeted exciting things in p medicine.
Absolutely, we hope so.
What are the bottlenecks? What’s bottleneck number one?
The bottleneck number one nowadays is the data protection regulation which is in development in Europe and the trouble with it being that it’s not specific to medical and health research. It’s a general framework which tries first to protect people using social networks like Facebook etc. but medical research has its particular framework which is already existing, proved to work, and needs to be maintained. An example that I would give is that the difficulty the European parliament has added in this regulation by its amendment is the fact that it requires a specific and explicit informed consent from each patient before their already collected data and material can be used in a new, even ethically approved, research. The difficulty with it is being that with already existing collections we might have, to have a specific consent for research that we will do in the future is not possible. We don’t even know what we may wish to do in the future.
Because cancer is a multi-gene disease and you cannot design a clinical trial on one gene which is damaged and mutated and therefore might be useful in terms of cancer therapy for certainty. It may well be that you have got one of the right genes but you don’t have the others and therefore you’re not allowed by this directive to look at the other genes retrospectively.
Absolutely, yes. And there are many examples on how this kind of retrospective look became very useful. For instance, some drugs may prove to be relatively a little bit better than an existing treatment on average but then when you look at the biomolecular data you find out that actually a subset of people may benefit from this drug where others will not. But this kind of biomolecular analysis you can only do if you can freely work on the data and material you have. You cannot always explain to the patient precisely which biomarker you will be looking on because simply you don’t know that.
So trastuzumab, for instance?
For instance, exactly. That’s exactly… yes.
Is Herceptin known in… trastuzumab in randomised trials in patients, all comers with breast cancer didn’t show any survival benefit but when we retrospectively pulled out the patients who had the HER2 new target for this drug, suddenly there’s a gap this wide and patients were getting double the advantage who had the right marker with the right drug.
Yes. And the other interest to be able to use the existing data in material because we could also do it in a prospective way. We could say, “OK, we think there is something there so we will do a prospective trial, collect data and material, consent the patients specifically.” But the trouble being that we will spend a lot of resources for doing so; we will spend a lot of time for doing so because even the simple data and tissue collection may take several years before it’s done. We will also, actually, expose more patients to an eventual little risk, even as little as it can be. So it has much more value and importance to work with already existing data and material without any exposure of any new patient to new risk without wasting money which has already been spent on the collection of taken material.
So do patients know this? What are patients’ views about this?
Usually when we ask patients and patient organisations, usually patients agree with it actually.
Usually meaning more than 90% actually.
Absolutely. Most of the time they do agree with this.
So why didn’t the politicians get that message?
I think that politicians sometimes do not know the actual realities up to the field, first of all. Then I think it’s sometimes an easy solution to say that if you ask the patient’s specific consent then whatever can eventually come out afterwards, well patients consent it. But it’s a bit hypocritical way to look on the things because actually when you look on the latest big scandals about violation of privacy and data breaches, they’re not happening because of the lack of consent, they’re happening because of the lack of the security. So even asking to the people a very specific, very informed consent doesn’t actually protect them from an eventual violation of data privacy; it’s the security of data that will protect them.
Patients that I speak to are excited by the idea that a piece of their tissue could help, by examining the gene targets etc. find a drug which might help them.
And it might not be a drug that’s available this year but it might be available in two years’ time.
Absolutely and many patients actually are surprised that it’s not routinely done. They would expect researchers to actually look on their material and to perform research with this data that might be useful for them but that might also be useful for the community of patients experiencing similar disease to theirs.
I’ve heard patients say by denying me this you’re actually blocking my human rights. Is that going too far?
I don’t think so because actually this whole discussion about the data protection and putting very strong requirements on that started from human rights, it started from the right on the privacy. But there are the two rights which shouldn’t be neglected which are in the same document as the right to the privacy: it’s the right to the research, there is a freedom of research which is a key right, and there is actually a right to the healthcare and there is no adequate healthcare without research because the adequate research underpins the adequate healthcare.
And also patients speak to me about the need for speed. We know that there are 800 new molecules waiting to be tested and we know that they’re all specific and they should, if they work properly, just hit the cancer target, not the normal tissue, that they should actually be safer for patients. Are you working on trying to improve the speed at which we test all these drugs?
Absolutely. Again, data can be very valuable to increase the speed because, again, now new technologies are getting available we are speaking about big data, about the possibility to cross data coming from different sources, from clinical research…
The same data?
Yes, clinical research about eventually medical records, some data from registries, and that pulling it together so that already existing data can give a lot of valuable information that will give answers to questions right now with very little financial investment as compared to a huge investment in time and money with the prospective research.
And we’re both working together with the European Alliance for Personalised Medicine in order to build a case to take to the European Commission and to the European Parliament.
Yes. I think it’s essential to be explained because I think a lot of politicians don’t actually realise what researchers are doing and how they’re doing it. They don’t always realise that actually every research, even done with material, is subject to an ethical approval which is very different from Facebook and Google.
My experience, for the last time, is that politicians who get cancer waken up to the point.
Thank you very much indeed, Anastassia, I really appreciate you giving us the time. Thank you.