How Patients as Stakeholders can Increase Physician Participation

I believe that the first question that should be asked of patients with cancer underdiagnosis should be long as I do better on the clinical trial than on the existing standard of care? And the reason for that is that the cutting edge treatments. Our first encountered in clinical trials. But not only that in many places.

Treatments may have been approved by the regulators for but are not yet reimbursed or provided by insurers or by a health service. And they form part of best standard of care. So patients and trials. Always or at least on what is recognized internationally as best care.

And then on top of that, they may have a placebo or they may have a new treatment. And it's been shown in many studies that patients who are in trials have better outcomes, irrespective of whether the new drug works or not. But they have better outcomes than those who are just in routine care. So if trials are so important for patients with cancer, why are there not more people recruited into them?

Well, the practical challenges are that firstly, there may just not be a trial that I'm running or that colleagues are running in my hospital. So I need to know where trials are available within. The region that's reasonably accessed for travel. So, you know, I live in Ireland.

So I need to know whether trial center is for a particular trial or open elsewhere in the country. So just that direct access to a trial is often not that easy. And this requires significant effort to find out what's going on and then to refer patients to trials as well. And as a clinician, I was always very busy.

The role with people outside my consulting rooms wondering, why is he taking so long with on the phone with them? And, you know, the pressure of getting through the workload is significant. And then on top of that, if you have to go exploring where you can refer patients to trials, that's an additional task. And with the best will in the world, I confess that I skipped that many times because I just didn't have time or opportunity.

And the situation is only getting more complex as ovarian cancer moves from being seen as a homogeneous disease with a one size fits all approach to treatment. Treatments are being developed which target very specific mechanisms which may or may not be present in an individual cancer. And for that reason. The treatments are they require.

Probably fewer people on the trail, but people are also much harder to recruit. So, again, let's take ovarian cancer. There may be, you know, centimeter dealing with that may see a couple of people a year with new diagnosis of that condition. But if one is looking for a very specific molecular subtype, there may only be two or three people a year in that same center with this specific tumor.

So it means that trials have to be spread over many more centers, over many more countries to find the specific markers and the specific mechanisms that a new targeted treatment personalized for that patient on the tumor can address. So there are difficult times ahead with more trials, more trial centers, but fewer patients in each trial at each center. This coincided pretty much with the arrival of COVID 19, and whilst it has wreaked havoc in terms of cancer diagnosis and treatment and care, it also has offered some new ways of working that are making researchers think how they run trials, making it easier for the patient to comply with the protocol, reducing the number of hospital visits, and providing real time data captured electronically.

Brendan is very positive about these changes in care for patients, but he takes it further and says there is room for even more involvement from patients and patient organizations. You'll excuse me if this is a little bit of a hobbyhorse of mine, but traditionally patients haven't really been treated as stakeholders in the trial. And that's a very paradoxical thing because of course, there are the people who really have the biggest stake in the outcome. And that's beginning to change.

And what I think I would like to try to work towards a situation in which patients and trials. Are seen as having a big contribution to play as individuals in the trial, and that means they really need to understand what's going on. I like to think of patients, almost as being. Co-investigators in the course of the way the trial was run, we often are slaves to a traditional way of measuring an outcome.

And while these traditional ways are very important, there are other things that patient organizations can draw to the attention of investigators and of those who are designing protocols. And so these are important to us. And, you know, things like quality of life questionnaires have been used for many years. But I think that, again, can be extended and for many conditions.

Things that are important to patients, you know, are often missed out from trials and they need to be included. There is a trade. Patient organizations can really help with recruitment of trials. So you have considerable reach through a very large number of people and you're also trusted.

So you're not some kind of giant corporation that people are, you know, feel a bit equivocal about. You're clearly working only for one thing, and that's in the interests of people with this condition. So you have a great opportunity to accelerate trials by helping recruitment. But there is a quid pro quo that you are entitled to ask for, and that is that views on how protocols are designed, you know, how invasive procedures are.

You may actually be happy to have procedures that are more invasive, even because the pharma company or the ethics committee may just really not know what they're talking about. You know, you may be able to accept things in the interests of success that an ethics committee might consider or a sponsor pharma company might consider to be a bit too much. So I think you have a great contribution on both sides of that and. The way that can percolates through the whole design of a trial can be really very valuable.