Improving Clinical Trials Information in Europe

Richard Sullivan, PatientView Eurocancercoms Project:

It’s interesting because actually patient information in clinical trials has got a relatively recent history. It wasn’t really until the 1970s with a lady called Rose Cushner who wrote about this in her books, and advocated patient information in the USA. And she was a major freelance writer, and breast cancer survivor. And we’ve seen it in the last three decades of course, increasing patient involvement within clinical trials. But at the same time of course, the breadth, the complexity, and just the sheer number of clinical trials has exponentially increased. And to a certain extent that’s actually collided with very large changes in demography so the aging population, ethnicity mixes in different countries, and to add a further letter of complication of course, is the technology involved in communication has changed beyond recognition over the last three decades. I mean I certainly remember having analog phones weighing twenty kilograms where you were able to make a phone call if you were not right next to an antennae to where David is sitting. Nowadays we see Yan sitting here with his wonderful new iPad with social media platforms; imagine what it’s going to be like in twenty or thirty years’ time.

So taken together there’s a perception – and this may not be correct, though – that there’s been a divergence between technology, what patients are seeking in terms of information and also just the sheer complexity of cancer clinical trials on-going out there in the community. So not to make light of information, we’re now talking increasingly about intelligence; information is roared undigested and what we really should be talking about is patients’ intelligence involvement in clinical trials.

Now as part of the Cancercoms project we did do a small survey on patient organizations over 716 in North America and Europe, and it was interesting high-level findings. Let me put these out for discussion. In Europe, only about 29% of organizations provide clinical trials information to their communities, and this compares to 78% in North America. Now the quality rating’s come out as pretty much equal, slightly lower in Europe though. The other big difference though is that clinical trials information is almost the lowest level information that patients are seeking from the organizations. There are seven and eight types of information that people go to for organizations. So the clinical trials information comes right at the bottom. And then finally, actually the way people are gathering their information is very different. In Europe, very strong preference, a face-to-face meetings and organizational meetings like this, whereas in the USA very strong tropisms for website. So the questions that arise from all this, and just from that general background is, first of all, why is the appetite for clinical trials information – is it because it’s too complex and not enough clinical trial activity? And more importantly, how should we be packaging information to turn it into proper intelligence for patients contemplating involvement in clinical trials over the next decade? Are social media platforms the right way to go? Should we be focusing exclusively on an e-solution? Or do we still need to remember that human beings are primates and we do like to sit around and groom each other in a more personal way?

Kathy Oliver, International Brain Tumor Alliance:

I think it actually is worth sometimes comparing Europe to the US where things are done differently over there to here – some good things, some things aren’t so good. But we were just talking earlier today in a meeting, comparing for example the clinical trials dot gov website with the EudraCT website, and lamenting the fact that the EudraCT website contained information about actual locations of clinical trials and who the investigators were and if you were a patient who you would contact if you went on that website, where clinicaltrials.gov has all the information there – phone numbers, email addresses, everything else. And I think the patients really do need to have access to all of this information in the beginning, and that isn’t always the case here as we’ve seen.

I also think – you’ve talked about packaging information – which I think is a very apt way of putting it. And I think really from the beginning, almost at diagnosis, we have to get into a kind of way of learning about clinical trials, not waiting until we’re desperate to get a treatment. We need to be told as patients and caregivers – because caregivers play an important role in deciding whether someone participates in a clinical trial – we need to be told almost in diagnosis that there are clinical trials, and we need explanations of how they work, we need explanations of the informed consent involved with that kind of thing, so it’s an education – it’s a package – right from the very beginning.

Selma Schimmel, Founder & CEO, Vital Options International:

Let’s get disease specific; we’re going to choose colon cancer as an example. Jola Gore-Booth, you are the founder and CEO of a newly established organization, Europacolon, so taking on clinical trials in colon cancer patients, how important is the issue of patient involvement and recruitment?

Jola Gore-Booth, Europacolon:

I was thinking as we were sitting around the table here, we’re all informed, we’re all passionate about our subject and we all know where exactly what’s going on. But out there, there is a massive population of people who continue to live under the impression that they are guinea pigs if they go into clinical trials. And I work on the ground with a lot of colon cancer patients throughout Eastern Europe, Central Europe, Northern Europe. Some countries are much better, obviously, but many countries still have this – almost taboo – and I think we need to go back to real basics.

You know you’ve written this amazing book, which I was delighted that we were participants in, A Guide for Patients with Advanced Cancer, I think we should think about writing a book that speaks at the same – there may be something out there that I may not be aware of – that speaks at normal people speak, and that points out not just the benefits of clinical trials but it also has to point out what are the disadvantages, but not confuse the patient to such a degree they’re thinking ‘oh I don’t know’ and ‘if I do this, this is going to happen and if I do this, this is going to happen’. I think it’s got to be done in a normal, inflammatory way in such a way that the patient will look at it – and we talk about informed patients, we talk about patient rights, and I think that they should be able to understand.

And I agree entirely with Kathy – where these are, where the trials are. Because another thing you put on clinical cancer trials and you get a plethora of information and you get completely lost. So I think an organization like ours should really have a guide to work on colon cancer trials are available, and I think there should be clear explanation on how they can benefit from it. And I think it’s Professor DeGramore, when I met with him once he was saying ‘patients have to understand that if they come onto the trial they’re offered something, they should feel extremely… almost honored that they’re being able to go into a trial, and that they understand how much this could have helped them’. And I was arguing with him ‘well yes, but they’ve also got to be told what might go wrong’.

So yes, that’s my view is that there should be clear and non-complicated explanation of the benefits and the problems that may occur at clinical trials.

Selma Schimmel:

It would be interesting to open it up since there are other disease groups represented here. Are there any other comments on the clinical trials issues before we move on? Yes?

Anita Waldman, Myeloma Euronet:

We put our clinical trials on our website and we educate our patients in seminars, and I just have the program again here: what’s the meaning and benefit to be part of a trial? And how can I benefit as a patient when I take part? And that is always and always and always again, our motto to bring the patients into the theme that they really understand why they need to be part of the trial as a cancer patient because… I mean there are risks but the other risk is much higher – to die.

Selma Schimmel:

You know in the US, we’ve been questioned is the word ‘clinical trials’ – is that a bad choice of words? And I’m just wondering from the European perspective – I know Stella you want to say something too – but I just wanted to throw that, and wondering is the terminology that we use to describe the clinical trials process part of the problem?

Nathan Cherny, Chair, ESMO Palliative Care Working Group:

I’m going to take a different stand. I think that there’s a real problem of what is being called the therapeutic misconception in clinical studies. Clinical studies are in general about the development of generalized data to help future patients; they’re not about individualized patient care. Many patients are lured into going into clinical studies, clinical trials, call them what you will… being told this is for their benefit. I think that that is dishonest, I think that there will be some patients who will benefit and there will be some patients who will be harmed, and even the very term ‘patient’ in the clinical study. When one goes into a study one becomes a subject because this is no longer a therapeutic relationship, this is a relationship between an investigator and a study participant. And part of the glory of that is the physician who oversees the care of the patient in the study loses flexibility about creating a nuance to approach to the individual patient.

I don’t belittle at all and I emphasize the importance of development of new generalizable data to push the frontiers of cancer care. However I think that the approach explaining the clinical trial process is important not to encourage the therapeutic misconception.

David Kerr, Current President, European Society of Medical Oncology (ESMO):

So Nathan and I are pals. That was a bit polarized and it’s good to be a debate, and I think it’s good to spend an afternoon going around in circles with it. I quite like bold automatic statements because if we can see things that are simple and clear, with a single voice it carries further in the corridors of power. And what Richard said, I find fascinating the fact that information in clinical trials was seventh or eighth or ninth or tenth. And for me, one of the hallmarks – you’re going to disagree on this – but one of the hallmarks of a quality cancer center is one that’s involved in trials. And one of the things I recommended to patients in the UK if you’re going to a cancer center, I would say ‘are you involved in trials? Are there trials going on?’ Because with that I’m not sure you’re going to get the quality of cancer treatment that one would mandate. That’s a really strong statement. And if we said something really bold and simple like that all these other really important, but in a way secondary questions about how we communicate, how we present detail would be quite different. Now, is that too controversial for us to come out and say if you go to a cancer center that isn’t doing any trials or studies whatsoever then we would be able to (inaudible) the quality of care you’re getting may not be of the first rank – that’s a big, bold statement. There’s some evidence to back it up but if we could see something like that, suddenly information in clinical trials doesn’t become seventh or eighth, it’s second or third, and we promote a whole generation of change in how we get colleagues and friends of patients involved in the whole clinical trial agenda.

Nathan Cherny, Chair, ESMO Palliative Care Working Group:

We don’t disagree with you. We don’t disagree at all and in fact, I think there was a wonderful paper written a couple of years ago, Ezekiel Emmanuel was one of the co-authors, about the epic obligation to participate in clinical studies because everyone benefits ultimately from the knowledge which is generated. And people who choose not to participate are essentially freeriders, and that is true for clinicians and that’s true for patients. So we don’t disagree whatsoever actually.

Stella Kyriakides, President, Europa Donna, Cyprus:

One major issue is that when a patient is diagnosed with cancer they have so much information thrown at them that it is impossible to also address this issue and understand the pros and cons of what it actually means. And as we have opened up the taboo, or the subject of cancer so that people actually talk about it in the general public without being a cancer patient, but they know about it and they know about prevention, and they know what types of cancer we need to look at. I think that this aspect of why people, individuals, patients should look at being a part of these wider studies in order to help to push the frontiers ahead should be talked about to the wider public and not only to the patient that finds themselves faced with a disease diagnosed and has to understand so much else and make so many decisions; it’s too much. But if this is opened up into the level of society, so that we know why these are going on, what they mean, what the pros and cons are. When you’re faced with this kind of reality then maybe you have a better understanding.

Tom Hudson, European Prostate Cancer Coalition (ECPO/Europa Uomo):

Just three simple, short statement. I support completely what Stella said because I think the idea of talking about clinical trials with patients is actually too limited to talk to people who are under a lot of pressure. It needs to be made more available to the general public so that everybody understands. There would be a better appreciation and more people will participate. If you’re targeting just the patients or the patients’ immediate family, suddenly the pressure’s on them, it’s difficult to interpret that.

Kathy Oliver, International Brain Tumor Alliance:

I know certainly in the brain tumor world that patients join clinical trials primarily I would say not because they want to benefit society in general but because they want to survive longer. We have so few therapies – there may be one or two – that are available as standard care; beyond that it’s all experimental, and patients are clamoring to go on trials – anything basically. Even if it means survival of two months, three months, whatever, that three months in a prognosis of 18 months is a major amount of time when you consider what life could be, or what death could be. So I’m not sure that we need to necessarily totally focus on patients going into clinical trials to leave a legacy for other patients. They’re going because they want to survive, certainly in rare cancers.

Selma Schimmel:

We could talk about clinical trials as part of the menu of choices early on instead of waiting to throw out the subject of a clinical trial when you’re facing more advanced disease.

END OF VIDEO

• Anita Waldman
• David Kerr
• EMCC AIA 2011
• Jola Gore-Booth
• Kathy Oliver
• nathan cherny
• Richard Sullivan
• Stella Kyriakides
• Tom Hudson

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