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TAKING STOCK - Taking Stock

EAPM Director Dialogues - Anastassia Negrouk

Publication date: 04.11.2015

Anastassia Negrouk is the Head of the International Policy Office at EORTC.

Speaking about how science (and how personalised medicine) has changed the game in cancer, she said: “We know more and more about how cancer develops, and cancer biology in general, and there is a need to better adapt the treatments to the individual profile of each patient, and to the cancer that they have in particular.

“This means we have to generate more research than we have been doing because, what we now understand is that we don’t understand enough. We need to learn much more about human biology.

“On top of this, because we have more information than we had previously, there is the possibility to target treatments better. In terms of the clinical research we are doing, we are not doing as simple research (as in the) past. It’s much more complex, frequently mixing a lot of techniques.

Negrouk explains that: “Cancer treatment was always a multi-modality treatment – it always mixed chemotherapy, radiotherapy and surgery - but now you can add on sequencing to better understand the nature of the tumour, as well as the tests on different biomarkers. The treatments we give are also more complex – it’s frequently not only drugs, but there are companion diagnostics involved, which may or may not be completely validated.

“You also have advanced therapy medicine products where you might have a specific device which is not yet registered, a device that is strongly associated with the administration of the drug. And, of course, we want to extract as much information as possible from each intervention.”

She adds: “All data and all material that are collected need to be used, and research needs to be done with it as far as possible and as much as possible.”

Expanding on this, she says: “Data material can be used for a long, long time. EORTC has collections which are 40, 50 years old and they are still of use. The advantage is that this material and data are already there, we don’t expose patients to additional risk, and actually save a lot of time as compared to more expensive prospecting.

“All the research we are doing has become much more integrated, much more interdisciplinary than even before, because now we add additional aspects and try to ask as many research questions in the same project as possible to actually save time and money.”

But these great advances and new complexities bring their own problems, not least when it comes to legislation and regulation. “Compared to before,” the policy expert says, “regulators are doing much more. About ten years ago we had only one directive with not many more rules, (but) since 2012 we have faced the issue of four major pieces of regulation – data protection, the clinical trial regulation, the IVD regulation and the medical device regulation.

The problem, she says, is that: “All of this regulation has been developed in different silos, in isolation, within teams within the European Commission, and sometimes even by different Directorates-General (DGs), each with a very different perspective.

“Data protection is done by DG Justice – their first concern is Google, Facebook, networks…nothing specific to do with research but, nevertheless, it will have a huge impact on research. The clinical trial regulation was done in DG Sante, the IVD regulation is now with DG Grow and, although within the Commission there are mechanisms for them to discuss (with each other), those mechanisms do not go far enough.

“It’s more and more the case that nobody is looking at the fact that some opportunities given by one regulation are completely annihilated by another. A good example is the transparency discussion over the last two years in the framework of the Clinical Trials regulation – the result has been claimed as a big achievement, that ability to share results…but with the data protection regulation all this achievement might simply be cancelled out by the tight rules.

“This complexity makes research more expensive, so it’s truly on the opposite of where research needs to go, where the patient care and the whole community need to go, because we need to integrate and not disassociate.

“Moreover, researchers are looking much more deeply at new methodologies and how to run clinical trials. More and more people understand that the classical way of development – phase 1, 2, 3 – is not the right way anymore. The classical takes ten or even more years, and we do not necessarily have this time. Also, with some types of innovative drug, it can be completely inappropriate – for instance, in the recent discoveries in melanoma, there has been a lot of debate about whether it is ethical to continue with randomised phase 3 trials when you have huge differences between existing treatment, or even no existing treatment.

“One problem comes with the lower level of evidence where you could give early access to the patient. But how will society deal with the higher risk because, of course, the level of uncertainty is higher? And here comes the need to collect real-life data – everybody agrees on this – but then again comes the data protection aspect, because real-life data means that you must have much fewer barriers to collect the data.

“This probably means having to have direct links between hospital medical records and research databases – of course, protected adequately so as not to jeopardize the patient’s safety, but nevertheless having less requirements for up-front approvals.”

So, are regulators being too cautious? Negrouk says “Probably ‘too cautious’ would not be the right term to use. Basically, regulators assume that if they add a few more rules, it will become safer in the end. This is a mistake, because I think that putting additional rules without actually verifying that they protect patients better is worse (than ‘too cautious’).

“Sometimes,” she adds, “increased levels of administration can even bring bigger risks, because if people spend the whole time complying with administrative requirements, they may miss something important.”

She is of the opinion that “regulators should look things critically and differently, maybe to do a specific framework for research, because currently data protection is general, clinical trial regulation primarily is there to put drugs on the market, IVD is to put IVDs on the market, but research is basically the way healthcare can progress’.

Negrouk explains that: “Over half the research currently done has nothing to do with drug development or putting products on the market, it’s just improvement of the science of the healthcare, of the knowledge, of our capacity to treat patients.

“What needs to be understood by the regulators is that their mission is not to protect the public from researchers, their mission is to create a framework for research to flourish, while guaranteeing the necessary level of safety and confidentiality for patients, of course. All data gathered within the framework of healthcare somehow needs to serve the advancement of our knowledge.”

Asked how this message can be put across, well, there are historical problems: “For a long time, academia was very shy in speaking to regulators. It has changed, but this policy work within the academic community is relatively recent. It’s not more than ten-years-old, and many academic stakeholders have only just started to have to some people specialised in this type of interaction which is radically different from the usual interactions that they have.

“What don’t make things easy are the silos, specifically with regulators, because you don’t speak to the same people. Researchers would like to focus on research but have multiple regulators to speak to. This is really not easy. Regulators need to understand this and take a bit more responsibility and try to defend research as a branch within the Commission itself. And also help stakeholders to have their voice when asking for something more integrated and more specific to research, which is a value by itself. This will be very helpful.”

EORTC’s expert calls for “a mechanism to be able to carefully monitor the impact all this new regulation we will be having. With a plan to find immediate solutions – not just in ten years because that won’t work. In the coming years we will see very clear illustrations of how all these regulations will potentially put new barriers up by having a bad interfacing between them.

“This could be an official multi-stakeholder committee having a dialogue with legislators, maybe regular meetings, where different stakeholders can come with their troubles about the consequences of the regulations, the impossibilities, and debate it to find solutions.

“If there is a will, it’s possible to do this,” she adds. “The clinical trials discussions were receptive to stakeholders and this definitely served the new regulation because, while it is not a perfect regulation, it was a good example of how Europe can produce a good piece of legislation. It was very unusual that it went that easily and that fast.

“So if there is good will and the understanding that research is integrated and cannot be split into bits and pieces to be debated separately, this would improve regulation.”

Author: Denis Horgan
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