COLLABORATING WITH PATIENTS FOR A SUCCESSFUL CLINICAL TRIAL

Dr Nicholas Zdenkowski is a medical oncologist and medical advisor with Breast Cancer Trials. He is the Chair of the Breast Cancer Trials Scientific Advisory Committee and works on a broad range of breast cancer research, including shared decision making, clinical trials and patient reported outcomes, particularly around neoadjuvant systemic therapy.

We spoke with Dr Zdenkowski about the importance of collaborating with patients and why their involvement is crucial for the success of a clinical trial.

“Collaboration with patients on clinical trials is crucial to the success of those trials, and there are two main aspects to that. One is in the design of the clinical trials, and that’s where consumers come in and a consumer is somebody who has a lived experience of a medical condition. They are able to give an understanding and commentary about how that medical condition, in this case breast cancer, affects people with that condition, and how that research might be able to be optimised to give the best outcomes for those patients who are diagnosed with breast cancer.”

“There’s a lot of complexity in designing clinical trials, and so consumers also have a lot of training to allow them to understand the research processes that takes place to be able to give the best advice and to help strike that balance between a good clinical trial that is going to ask a question but that might not be feasible or practicable and the trial that might be very practical, but doesn’t necessarily answer the question.”

“We need to be able to produce interventions or new treatments that are going to improve outcomes, and that people are going to be more informed, and willing to receive a new drug that has lots of side effects is something that people aren’t going to want to receive.”

“So, we need to work with consumers right from the start of those clinical trials through to the reporting of the clinical trials. The second aspect is in partnering with the potential trial participants.  So, trial participants are key to understanding the effect of an intervention, and that’s what we’re doing in trials, is working out if some new way of treating breast cancer can improve those outcomes.”

“And that might be reducing the likelihood of breast cancer returning. It might be the same degree of prognosis, but with reduced side effects, or it might be related to having less treatment with the same outcomes. And that’s something that Breast Cancer Trials has been quite interested in. So, working with those trial participants is very important and allowing trial participants to contribute fully and to understand what they’re participating in is the second key aspect of a successful trial.”

Learn more about participating in a clinical trial.

How can potential participants make informed decisions about participating in a clinical trial?

“There is a process of consent for a clinical trial. Consent is often considered in the form of a document. The document is called a patient information and consent form and that is signed by the patient when they are examined and becoming a trial participant.”

“The real consent is in understanding what the trial involves, and so signing the piece of paper is just the documentation of it, and it’s often a very difficult document to understand. It might be 20 pages long. And so having those discussions is crucial. That’s with the clinician, with the doctor who is offering that clinical trial, with the clinical trial coordinator, who is often a nurse who can sit down and take some time to explain some of the nitty gritty around the trial and what it involves.”

“Taking some time to go and talk to loved ones, talking to other doctors, a GP for example, and then coming back and asking questions, and really understanding what they’re going to get into. If they have reservations, often that can be addressed about what the trial involves, but ultimately, it’s a choice.”

“It’s not an obligation to participate in a clinical trial. For some people, it just doesn’t fit, and if they’ve thought about it, and decide against it, then that’s no problem. That’s not an issue at all because my real expectation and hope is that for people who participate in clinical trials, they do their best to continue with that clinical trial to enable the trial to collect the information that is going to lead to outcomes from the trial that we can interpret and then introduce into routine clinical care.”

Learn more about what is meant by Informed Consent and other key terms used in breast cancer research.

How important is clear communication between a medical professional and a patient during the clinical trial process? What should patients expect?

“The patients should expect that the doctor talks about what standard care is in the first instance because that’s what we have available and then after that they would talk about the potential clinical trial that’s available and I would expect that it is a very clear process and that they take the time right at the outset for the potential trial participant, who’s currently their patient, to really understand what’s going to happen as part of that trial.”

“It’s a problem if later on down the track there are surprises. If there’s a surprise as a result of the trial that could have been anticipated, then the patient might be wrong footed, and they might then feel as though participating in the trial is not for them.  And if they then pull out of the trial, which is well within their right, that has the potential to reduce the impact of that trial.”

“Or if too many people drop out of the trial, then the results just may not be interpretable, and the trial is done in vain. And that’s a shame because of the amount of effort that goes into running clinical trials. So having that time up front is just so crucial.”

Learn more about the importance of language between patients and their health team.

What support systems are in place to assist patients when participating in a clinical trial?

“An important component of clinical trials is the involvement with the clinical trial coordinator. So, a clinical trial coordinator is there to help smooth that process. It can feel a little bit overwhelming to many people because cancer is really confronting and it’s an emotional process going through a cancer diagnosis and treatment.”

“And then to layer the complexity of a clinical trial on top of that can just feel too hard. But having a clinical trial coordinator helps and goes a long way to smoothing that out and making it a whole lot easier, and in fact, they coordinate a lot of the treatment for those participants to make it easy so that they can come in, have the trial treatment, and be a source of questions and answers.”

“There’s a lot of information out there about clinical trials as well. Breast Cancer Trials has information about clinical trials. Breast Cancer Network Australia has information as well. And what I’m seeing overall is that society understands that clinical trials are a key aspect of routine patient care.”

“And so, there’s increasing acceptance of clinical trials and a lot of oncologists see clinical trials as being crucial. So that people come in asking about them and understanding what the trials are about. And that makes people more confident that the clinical trials are a treatment that they can rely on.”

Learn more about clinical trials.

What are your hopes for the future of breast cancer research?

“That’s a hard question to answer. There’s lots of things that that we can do, and over the years we’ve seen reduced breast cancer mortality, more people surviving breast cancer, and over the coming decades, I think that it’s going to take a long time before we can prevent breast cancer, but I’d like to see a lot more breast cancers prevented and there are ways to do that.”

“I would also like to see patients have sufficient confidence that they can live their lives after a diagnosis of breast cancer, without having to worry about the potential for that cancer coming back, that we can tell them for sure that this cancer is really not going to come back. One, because the treatments have been so effective. And two, because we’ve got a test or another way of knowing that for that individual, the cancer is almost certainly cured.”