Bioethics in Clinical Trials

Roche's Katrina Bramstedt discusses bioethics and how it can help patient centricity. 

Bioethics and Patient Centricity

What is the role of bioethics in medical decision-making? Here to explain more about this fascinating topic is <a rel="noreferrer noopener" target="_blank" href="https://www.linkedin.com/in/prof-katrina-a-bramstedt-phd-32459b9">Katrina Bramstedt</a>, global head of bioethics at Roche. During this episode of the Totally Clinical podcast, Katrina discusses the crucial role bioethics has in the industry, why she believes every pharmaceutical company should have a bioethics department – and expands on how bioethics can support patient centricity."Patient centricity is very much connected to bioethics because we want to make products that patients actually need, not products that we think they need or we think might be nice to develop for whatever reason."

Global Head of Bioethics at Roche, Katrina Bramstedt, discusses the crucial role of bioethics in medical decision-making and how it supports patient centricity.

Global Head of BioEthics at Roche

Katrina Bramstedt

How Bioethics Support Clinical Trial Patient Centricity ✅ (Podcast)

How Bioethics Supports Patient Centricity

How Bioethics Supports Patient Centricity - Katrina Bramstedt

This week. Katrina ramstad, global head of bioethics at Roche, joins me

on the podcast. Welcome Katrina, could you start by explaining more about your background and what inspired you to get into the industry? I absolutely am passionate about bioethics.

I got into the field about 20 years ago when I had just taken a course when I was doing a bachelor's degree, I guess it was, and I liked it so much. I took some more courses, got a master's degree, got a PHD, did a fellowship, and I've worked across several sectors. So

academia, I've worked in hospitals as a bioethicist and also in industry, and I just love it. So it's a lot of fun.

It's inspiring because I enjoy solving problems and I love helping patients. Could you summarize what bioethics is and why it's so important? Sure bioethics, some people might think it's like about philosophy and there is some philosophy in it. It's one of the foundations.

But more than that, it's we look at and we study ethical problems, ethical dilemmas that are connected to the life sciences, health sciences, medicine, things like that. And we try to deconstruct or take apart those problems. So we can get to the root cause or the root cause and then find solutions. And it's really important in the setting of health care and medicine because people's lives are at stake.

And even if it's not saving a life, often it has to do with the quality of a person's life. So if there is some sort of bioethical dilemma going on and it's resulting in harm to a patient, well, then we've got to get to the root

cause of that. And get a solution that's ethically appropriate. So very important field.

And I imagine that most pharmaceutical companies should have a bioethics department. I think that they should. I think every pharmaceutical company should have a bioethics program or an official department, because what that does is it puts the people in place, hopefully even at the leadership level, that have a bioethics framework for thinking. They have a bioethics mindset and sensitivity to ethical issues.

And that way, too, you can build in ethical constructs to your way of working, whether it's developing product or selling product, whatever it might be. But you do that in a proactive way instead of always reacting to problems. That's not the best way to work, although we have to be able to do that as well. But ideally you want to frontload

and build in ethics into your systems because if you have ethical behavior, compliant behavior will naturally follow behind that.

Yeah, that makes perfect sense. But could you talk me through the ethics consultation process? Absolutely so ethics consultation involves someone approaching you and it can be anyone. It could be for someone, for example, someone at a lower level, like a lab technician.

It could be someone at a very high level and an executive role coming to you with a problem or a dilemma. And that has some sort of ethical component to it, ethical piece to it, and asking you for a solution or guidance. And what we do as bioethicists is because of our extensive training, we know how to look at a problem or a dilemma. We know how to take it apart into all of its various pieces and components, find the root cause and

then identify potential routes to solve it, and also give people guidance on paths not to go down so that they avoid getting stuck in the weeds, places that they shouldn't go in the setting of a problem.

So we sort of keep them on the right side. That's that's basically ethics consultation in a nutshell. Interesting so it's not just about what to do. It's also about what not to do.

I imagine that considerable challenges must arise during this process. Could you explain more about these? Sure I think one of the biggest challenges is time, especially if you are working in a reactive way. You may be presented with a situation involving, let's just say, maybe it's a patient and things are urgent.

So the clock is ticking. And fortunately they do come to you as an expert, as a bioethicist, and ask for your help. And you're aware, you're cognitively aware of time, but you also still need to do a good and appropriate job. So I'd say time is a big factor sometimes in

many situations, but there can be other issues too, like sometimes ethical dilemmas or problems are also twisted and mixed in with things like legal issues, or perhaps even a cultural issue in a setting where something is happening.

And so you have to consider all the contextual features of a problem, not just, OK, this is the problem. This is why we have to be very careful when we break a problem down so that we are looking through, yes, an ethical lens, but we're cognizant of all the other features that may be part of an ethical problem. How is the topic of bioethics taken into consideration when it comes to patient centricity, for example? Great question.

It's patient centricity is very much connected to bioethics because we want to make products that patients actually need, not products that we think they need or we think might be nice to develop for whatever reason. But you have to have what we call meaningful innovation. What does someone actually need? What's their situation?

So we can only find that out by actually reaching out and talking to patients. But of course, when we talk to them, we have to listen to them. And often we bring them into the process

of developing new products through what we call co-creation. So we actually bring them to the table and they're part of the team in developing new things, new technologies, new products, however it is you want to call it, but we actually bring them to the table.

I think it's really important. This ties into the idea of patients as stakeholders. We've actually written about this at tech guru before. Absolutely they are the stakeholder.

They're our most important stakeholder. And I like to think that when we're working, even when a patient isn't in the room with us, that we imagine and we pretend that a patient is, in fact, in the room with us, because that will guide our reflection, that will guide our decisions, will remind us what we're doing and why we're doing this. If if we forget about the patient, then we're going to just be on this track of building something, making something. And that's

not what working in the pharmaceutical or even the medical device industry is about.

If we think about the topic of influence, are there any international organizations or even individuals that inspire you in your work? Oh, for sure. There's a great organization in Europe called in Rio, which is the European network of research integrity offices, and they're staffed with experts in the area of research integrity, which is vital to research quality. They give guidance, they write position papers, they sponsor conferences.

They're really a great group of people that helps us all

keep on keep on the good path for building and doing robust research also and has a great bioethics department staff with wonderful people that are very skilled. There's listservs out there that are filled with bioethicists that many of us belong to, and we networked together. And it's just a great, great way of having feedback. Of course, confidentiality you always maintain, but nonetheless, they're a great source of inspiration and advice at times.

If we think about multinational trials, there are many challenges that can arise because countries have different ethical foundations. How do you approach these obstacles? First of all, let me just say, you do need to do multinational trials. You can't just say we're going to do trials in the United States or we're going to do trials in one particular fantastic country in Europe.

That's not a good way of working for a whole bunch of reasons. But back to your question, as far as ethical issues and challenges, I

believe that you can set a baseline, really good ethical foundation that applies globally. What you don't want to do is have sort of the fighting skill of ethics and you lower your standards for one region and you raise your standards for another reason. What we want is everybody to come up to a baseline standard of ethics where we all agree that we're going to function and adhere to very basic and very important ethical principles.

Yet that approach makes sense. Looking to the future, where do you see bioethics as a practice moving? Well, first of all, I'm seeing more and more regions of the world developing ethics training programs. And this is really vital.

People who work in the field of bioethics need a really good doctoral and fellowship training program to put them in positions where they have the capacity

to help. All right. So that's really important. I also see bioethics moving in a more proactive way.

So we are fantastic at solving problems. That's that's what we do. And that's a big part of our training. But we absolutely need to have efficiency and workflows and things like that.

And to do that, you need to work in a proactive way. And I see more bioethicists seeing the value and the importance and really the need to do proactive bioethics work. I also think that there is an awareness globally and certainly within industry that there are certain areas of medicine that you really have to be cognizant of ethical issues. And this is, for example, personal, personalized medicine, neuro ethics, data, ethics and artificial intelligence.

And once people embrace this, that, yes, we need ethics, it allows us as ethicists to do our work, which is great. So that that's what I'm seeing. A general closing statement that I always like to remind people and organizations is ethics is a strength. It's not a weakness, it's not a barrier.

It's not a hurdle in your organization. And if you really embrace it as a strength, you'll see some real positives

and some real benefits. So try to adjust your mindset if maybe you've had sort of a dimmer view of ethics because maybe you've had trouble with an ethics committee or something like that. That's only one very tiny, tiny aspect of what bioethics is and what bioethics does.

So embrace it as a strength.

Katrina Bramstedt

Global Head of BioEthics at Roche

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