In the first of our two episodes about clinical trials, we hear from Professor Jon Wadsley, Clinical Director of the Cancer Clinical Trials Centre at Weston Park, about what clinical trials are, how they can benefit cancer patients, and how the Charity supports them.
Ruby Osborn: Hello, and welcome to the Weston Park Cancer Charity podcast, sharing stories about our work, what we do, and the people we support. From funding life-saving research to providing practical help and emotional support, it’s our job to care in every sense for our patients and their families.
The Charity has been a long-time funder of the Cancer Clinical Trials Centre here at Weston Park, so in this episode we’re doing an introduction to clinical trials – what are they, what is it like taking part in one, and why are they so important? I’m Ruby, and I’m joined by Professor Jon Wadsley, consultant clinical oncologist at Weston Park Cancer Centre and Clinical Director of the Cancer Clinical Trials Centre.
Jon Wadsley: A clinical trial is a way of testing new treatments, so if we didn't do a trial we wouldn't know whether a new treatment is better or worse than existing treatments, we can't just assume that new treatments are necessarily going to be better. So it's absolutely vital in the pipeline for developing better treatments for our patients to do trials, and certainly many of the treatments that I give to my routine patients in Weston Park today, we give them because of trials that we've done in the past that have shown that that treatment is the best way of treating that particular cancer situation.
So there are various different sorts of trials that we might consider. Perhaps the most obvious sort would be testing a new drug treatment, to use an example that’s been very much in the media recently a trial to test a new vaccine has been going on recently in covid. So those sorts of trials are what we call interventional trials, so patients are being given a new treatment. Often within the trial there are two arms in the trial, so some patients taking part will receive the new treatment, some patients will receive either a placebo or the current standard treatment, and the treatments are then compared to see whether the new treatment is better. But there are many other sorts of clinical trial as well, sometimes we undertake what we call observation studies where we simply gather information about how a patient’s getting on a particular treatment and maybe gather different new information about the effects of the treatment on quality of life or other really important factors that are perhaps not already well understood.
Ruby: The Cancer Clinical Trials Centre at Weston Park gives the opportunity for local patients to take part in clinical trials. So how can someone get involved in a trial?
Jon: The important thing to say from the outset is that taking part in a clinical trial absolutely always is an optional voluntary thing, nobody should ever feel under any pressure at all to take part in a clinical trial. So the possibility of taking part in a trial though would generally be introduced by the patient’s doctor in a consultation when a new treatment is being considered. So the doctor will always discuss what the best standard of care option would be in that situation, but if there is a trial available would also introduce that as an option available to the to the patient.
Any patient should feel able to ask in the consultation and increasingly we do find this is a question that the patients do ask us, is “is there a trial that I can take part in.” We do try very hard within Weston Park Hospital to have trials available for as many groups of patients as possible. There are sometimes gaps that we don't always have a trial, so please understand that if we’re not able to offer one at any one point, but I would absolutely encourage anybody to ask their doctor.
And you would expect there to be a, if the patient’s potentially interested, quite a detailed verbal discussion about exactly what would be involved in taking part in the trial. Almost always at that appointment, if the patient was interested in taking part in the trial, they would be introduced to a research nurse who would be able to have again a slightly more detailed discussion and answer any questions they may have, and also provide the patient with some written information to go away with because we understand that there's a lot of information take on board in the consultation.
And if still interested then a further appointment would be made for the patient to come back and see their doctor for further discussion, and if they do wish to proceed and take part in the trial at that stage they would need to complete some paperwork, what we call a consent form. So this formally acknowledges that the patient understands what's involved with taking part in the trial, that it’s completely voluntary, they can withdraw and stop taking part in the trial at any point if they wish to do so.
Ruby: As part of the preparation for entering into a trial, the team will check that the patient is definitely suitable for the trial, and that’s it’s safe for them to take part, through a process called screening.
Jon: Very often it will involve blood tests, taking a careful background history and what drug treatment they're taking already, almost always it will also include having some scans. So there will be a number of investigations that need to be done, but once all the results of those investigations are back, if they're all in the desired range, then we can go ahead and register the patient into a trial.
Ruby: But there’s one more key step before treatment can begin, to make sure the trial gives the best quality data.
Jon: If it is an interventional trial where we’re comparing a new treatment with an existing treatment, one really important concept that it's important to understand is what we call randomization. When patients get to take part in trials, usually they're not able to select which treatment they have in the study, they are randomly allocated to one treatment or the other. Scientifically it's really important that we do it in this randomised way, because if we were to select patients and give them the new treatment and give other patients the older treatment, that may introduce bias into the study so at the end of the day we won't know whether the new treatment was better or we just selected the better patients to have the new treatment. So it's really important when we’re testing something new that it is done in this this this randomised way. I appreciate for some patients that that can feel difficult, putting yourself in for something and not having control over which treatment you get, but we can assure patients that at the very least they will receive the best standard of care treatment because that's what would be used as it is the comparator in the trial. So once the patient’s been randomised then usually very soon after that we can actually get on with the treatment, whatever that involves.
Ruby: It’s important to note that, by their very nature, there are no guarantees about the outcome of a trial.
Jon: Obviously we don't know at the start of the trial exactly what the treatment benefits are going to be. If we knew that the new treatment, if we already knew that it was going to be better then we wouldn't be needing to do the trial. We need to test it so we can never guarantee that the new treatment the patient may access on a trial is going to be better. What we can guarantee is that patients who take part in trials do almost always get a higher level of supervision and support. So patients who taking part in trials are assigned a research nurse and are able to have regular contacts. Often there are more hospital visits for safety monitoring as well for patients who take part in trials, and whilst for some people we acknowledge that that can be burdensome, I think many patients do actually value that added supervision.
Ruby: Weston Park Cancer Charity and the Cancer Clinical Trials Centre have been working together for many years, and we’ve agreed another grant to fund some of their staff through 2021.
Jon: Well I should say we’re hugely grateful to the support for the Charity and it would be very difficult for us to carry on and be able to provide the breadth of trials that we are able to do without that support so we're hugely grateful for that. Cancer Clinical Trials Centre really receives two main blocks of funding. The first block is to support a number of our research nurses, so all our research nurses are obviously trained nurses, but research nurses then have additional training to enable them to be able to support patients who are taking part in clinical trials. So we said before, when we're testing something new we absolutely owe it to our patients to make sure everything is done even more carefully than usual, to make sure that everything is done safely, and there are very high standards that we have to work towards when we're looking after patients in trials and our research nurses are absolutely trained to those standards.
So we have a number of different teams within Cancer Clinical Trials Centre who look after patients with different sorts of cancers and within each of those teams one of the nurses is funded by the Charity. So those nurses, I would say one of their really critical roles, something that we wouldn’t be able to do without this support, is supporting patients when they first come to us and first are told about the possibility of taking part in a trial. Being able to spend time with those patients, to go through the information really carefully and clearly, make sure that any questions or concerns are answered, and just really just help be alongside the patient to decide whether taking part in the trial is the right thing for them. So that that's really critical activity and we're really grateful for the support to do that. So that's one big block of funding that we’re given.
The other thing that's a more recent initiative is that we have been really keen in recent years to run more trials that we describe as early phase trials, so these are testing really brand new drugs that may not ever have been used in humans before, and testing whether they may have value in our patients with cancer. So this is bringing even more opportunity, particularly for patients who have perhaps run out of routine standard treatment options altogether and really don't have any other options for further treatment at all beyond taking part in this sort of trial. Now you can imagine this this sort of study, because the drugs are brand new and have not been used before, they need extra careful monitoring so it does need additional infrastructure support to manage that safely. So we're really grateful for the last couple of years the Charity again have given funding to support and boost the team to help us support that work and really increase the opportunities for those sorts of studies available to our patients here in Sheffield.
Ruby: Our region has higher incidence than the national average for many cancers, meaning there are a lot of people needing the help of Weston Park Cancer Centre, but also a lot of people who could potentially take part in clinical trials, and the Cancer Clinical Trials Centre is working hard to support as many as possible.
Jon: So typically at any one time we would be running over 200 clinical trials for patients. So we need a large number of studies because obviously we treat patients with a range of different cancers and the trials tend to be specific to a particular type of cancer, and even more so actually these days with the development of what we call personalised medicine, so subcategorising cancers even more and more. Things are a little bit strange at the moment because of the whole covid-19 situation so we've had a very strange year, many studies had to be paused at the start of the pandemic. So we are recovering but we're not we're not quite up to full speed at the moment. In terms of numbers of patients involved, so typically in a year we would recruit four or five hundred new patients to clinical trials through the Cancer Clinical Trials Centre, but obviously that's just the new patients who take part, we have many many more patients who've been recruited in previous years who are still on follow up in studies or potentially still on treatment in studies who we interact with each year, so there are many more patients that who benefit from the support of the Cancer Clinical Trials Centre each year.
Also we have we have excellent clinicians, so many of my consultant colleagues are considered national leaders in their field who either lead their own trials or are very much engaged in national trials that are going on, so lots of opportunities there. And then having the Cancer Clinical Trials Centre is a fantastic resource for us to be able to support that work so having the research nurses, the data managers and all the admin team that work behind the scenes to make all these things happen is great opportunity to really do this work, so I think all those things sort of play together to create a really good opportunity for doing research that obviously benefits not only our own patients but also patients across the country and actually across the world.
As I hope people have seen from what I’ve said, this is vital work. It's the way that we improve things and develop new treatments and we are absolutely desperate to continue that great work.
Ruby: And in his roles both overseeing clinical trials and treating patients, Jon has seen first-hand the difference that clinical trials can make.
Jon: Just thinking of an example in in my own personal experience in treating thyroid cancer, so the majority of people with thyroid cancer have a really good outlook and the majority of people are actually cured by an operation and sometimes some radioiodine treatment. But just occasionally there are a subgroup of patients who have very advanced unpleasant disease that causes them a lot more trouble and can prove fatal. And until very recently, certainly when I started as a consultant here 16 years ago, there were no treatments available for that group of patients really, we just looked after them managing symptoms as best we could, but there weren't any active treatments. So a few years ago an opportunity came along to test a new tablet drug that had been developed for treating exactly this sort of condition. I can think of one particular gentleman who came really in a terrible state, he had thyroid cancer that had spread to the bones in his pelvis and consequently he was it was barely able to walk when he first came to see me. And he took part in the trial and was randomised to receive the active drug, this new drug, and really the transformation for him was just amazing. Within a matter of just a small number of weeks his symptoms were all better, and this drug actually managed to keep his cancer under control for a number of years, and it just makes me smile, every time he came to see me and the research nurse for monitoring how things were going and each month he’d come telling us the latest DIY project that he’d done, either fitting a new kitchen or retiling his roof, and you know this was somebody who was barely able to walk when they first came to see me, so yeah I think that illustrates the sort of impacts these teams can have. So I now routinely every week now I see patients in clinic who are able to receive this treatment and really benefit from it. If it hadn't been for us doing that trial, we wouldn't have that treatment option available to patients today.
Ruby: That was Professor Jon Wadsley, clinical director of the Cancer Clinical Trials Centre. We can only enable research like this with the help of our supporters. If you’d like to donate, or get involved, please visit westonpark.org.uk. And if you want to hear more about clinical trials, join us for our next episode where we’ll be talking more about early phase trials.
Dean Andrews: Cancer changes everything, but so can we.