Patient Centricity in Pharma

Rob:  Medical publications are ultimately about patients, but how often are they actually created WITH patients? 

Patient centricity has become a familiar phrase across our profession, but what does it take to really integrate patients meaningfully throughout the process--from research design to authorship and publication? 

This is In Plain Cite, a podcast exploring the biggest questions and trends facing medical publication and communication professionals. I'm your host, Rob Matheis, President and CEO of ISMPP. 

Today, I’m joined by Steve Clark, a patient advocate, and founder of Strive for Five and Beyond. After being diagnosed with stage 4 colorectal cancer in 2013, Steve became deeply involved in patient advocacy, research, and medical publishing. 

Together, we’ll discuss what genuine patient partnership looks like and how publication professionals can put it into practice. 

Let’s get into it. 

[End of Intro]

Rob: Maybe we just start right from the top, Steve, and really talk about patient centricity, as a whole. So what does it mean to be, uh, patient-centric in a publications environment? What do our listeners need to know?

Steve: For me, the key part about patient centricity in publications, it's actually about working with. It's about having patients integrated into everything that you're doing. Obviously you need to think about patients as an audience, as recipients of the publications, but also as co-producers, as co-authors, as being involved in the process.

Rob: Yeah, I think that's an interesting way to put it, right? So for a while, you know, we talked about patients as being part of the outcome, trying to reach patients and make sure they have the information they need. But now we're taking a different approach or a different discussion and saying, well, they're kind of part of the ecosystem.

That's interesting to me. So where do they first get involved? Where should patients initially get involved in this?

Steve: Generally speaking, the way in is through research, is being involved in studies. So a lot of R&D, especially in academia, now involves patients as co-investigators. And so when a patient is involved in the study, they get involved in the writeup, they get involved then in the publication, and that, for many people, is the route through.

Another way that patients get involved is by being asked to review a lay summary. So being brought in right at the end of the process. Whether it be a clinical study or a review article or whatever, and then a lay summary is written, and a patient may be asked, uh, "Will you have a look at this? Does this make sense to you?"

Rob: Now, I think that we'll definitely dig more into some of the process, but maybe we just take a step back and get a sense as to, why is it so important to have the patient perspective in the whole publishing process, the research process? Like take us back to the basics of that.

Steve: Actually it goes within what you said. The patients are part of the ecosystem. In fact, if you look at, in terms of medical research, medical publications, patients are the ecosystem. It's not just that they're an audience member, it's what all of the work is about. And so the key thing about working with patients within the publication itself, within research itself, it's relevancy.

It's making sure that what you're working and what you're researching and what you're talking about is actually relevant to a person who is living with that disease. And here I should say the caveat, I'm talking about patient centricity, but we're also talking about caregivers within this as well.

Within many diseases, some of the rare diseases, all of the diseases of young children, often when we're talking about the patient, you'll be talking about the parent or the caregiver for that person as well. And I think it's that lived experience aspect that really adds value.

Rob: And so the other byline authors, they can't bring that perspective from your perspective?

Steve: Not fully, I would say. They can bring some of it. Obviously, a lot of them have access to patients. They see patients, they talk to patients, but that's different to actually being a patient. And one of the things I've seen a lot coming through recently is, doctors are accepting the fact-- medical doctors, I should say, are accepting the fact that they have a great understanding of the medicine and of the physiology, et cetera, but what's going on for the person that's living with that disorder is something else.

And actually then they want that input more and more. And I'm seeing that in R&D. The studies that I'm involved in as one of the lead authors, from a patient perspective, the welcome from the clinicians is you give a different aspect of things. It adds more depth. You know, if you don't have the patient in, you'll have some good input, and you'll have experts involved in your work, but you're just missing that extra little nugget.

Rob: Yes, that's really important because at the end of the day, patient care is the objective of the publication itself. Would you say that the clinical endpoints that are collected or reported could be different when a patient is involved in a publication?

Steve: Absolutely. Absolutely. Sweeping generalization for most clinical studies, the primary outcomes of a study are fairly embedded. They're fairly standard, you know, uh, measures of efficacy, et cetera. Patients can help with the nuances of that. But in reality, the majority of the studies, I would say that's pretty much straightforward.

The secondary outcomes, working with patients, you get a completely different perspective on things. What do you talk about in terms of quality of life, what is, what is acceptable as a risk? What is acceptable as a side effect? You get that from patients. You don't get that from being somebody that works in that disease area.

I see a lot of differences between different publishing houses, different approaches. There are some where there is almost no recognition of the patient. There's some where patients would only be recognized in terms of being able to look at a lay summary. And there are others who will recognize patients as an author, and I don't just mean a co-author on a clinical study, sometimes as a lead author. I think the patient-led piece can be very, very valuable. 

Rob: Yeah. Yeah. You know, I've been doing publications for well over 20 years and, for years we've been talking about patient perspectives, patient centricity, and I'll be honest, there's, you know, in some cases a lot of lip service paid to patient centricity. And, not that we're here to point fingers or anything like that, but in the spirit of improvement, what are some of our, our listeners may be missing? Like, what perspective do you want them to have or misconception... Not misconceptions, but, what are they missing?

Steve: I think that's a really good observation, and actually in a lot of ways, the term “patient centricity" itself allows 

people to cop out. Because, you know, pretty much everything that we do in terms of medical research and medical publications is of course patient centric by design. That doesn't necessarily mean that you're working with patients on it.

So I'm not a big fan of the term patient centricity because it can allow people to do a tick box and say, "Well, we're thinking about patients." You see, the slide is being done. Here are all the things we do, and patients are at the middle of everything, so we are patient centric. There is a difference there between that approach, to more of a collaborative approach to everybody working together and patients as being partners in the process.

I like talking about integrating patients or involving patients so that we're embedded within the whole process as we should be as partners within it.

Rob: Makes good sense. Now, I'm thinking with my listeners' perspective, on this topic, and, um, their world got real complex, real fast, Steve. So nowadays, you know, they have to think about all the different target audiences that they wanna reach. They have to think about all the stakeholders. They have to think about artificial intelligence, machine readability, and so now here we are on this podcast layering in what we've been saying we've been doing all along, but saying we have to do it at another level. Um, do you feel this rises to the top of all those priorities, or at least near the top of all those priorities?

Steve: It's gotta be, if it's not at the top, it's gotta be close to the top. The reason being what we said right at the start, everything that is being done in terms of medical research, medical publications is about a patient, so it should be done with patients. Simple.

Rob: Yeah, I mean, it makes very good sense, right? 'Cause there's no point in doing it if you're not going to meet the 

patient's perspective or have that input. It really does make sense.

Steve: The thing I would say though, Rob,if you haven't worked with patients in developing a manuscript or developing a research program, it feels like it's hard to do. It feels like a big task. It's actually not, you don't have to go out there and engage with thousands and thousands of patients.

If you work with a patient that can represent their community, it's one other seat at the table that gives a perspective that can add depth to the final output. That's a mindset thing that's worth addressing. So rather than, "Oh, you know, we've got to engage a patient," it's like, we can engage a patient.

Rob: Okay. Okay. I like where we're going with this because I think we might have sold our listeners on the fact that this makes good sense. It's intuitive. We should probably have patients involved. But some of the folks out there may be thinking, "I don't really know how to do this."

So it's Monday morning, I open up my laptop, I'm starting a brand-new publication plan. I know I'm supposed to involve patients. What are the nuts and bolts, like, best practices that a publication professional in the trenches should be thinking about when they're engaging patients or trying to engage patients?

Steve: Uh, how to contact the patient first... How to find a patient, I guess, is a key watch, isn't it? It's a tough one.  feel like a tough one if it's the first time that you've done it. And I get that. And if you sit away from a clinical environment, it feels like patients sit very, very far from you.

Um, and the thing is most academic institutions, most and all, almost all hospitals have patient forums. They have patient councils. Your first point can be to go to them and say, "Would anybody like to be involved?" The other thing that you can do as a very simple route through is the patient organizations, the different charities that support. A lot of those have very good patients that are active with them, and they can say, "Oh, this person’s a wonderful spokesperson." They could be involved. So your route to get to them can be really quite simple.

Rob: Yeah, and I guess it makes good sense if there hasn't been a patient involved in the early ecosystem. I suppose if we had patients involved in the clinical trial design, reaching back to our clinical teams and seeing if there's patients that have been involved in the study, obviously makes good sense as well.I'm sure if that's a possibility for our professionals out there.

Steve: Absolutely. And these days, if you look at, um, the FDA, are developing guidelines in terms of, involving patients in research. In fact, the World Medical Association has come out with its guidelines.

It's a Declaration of Helsinki, which was published the year before last. And they, they talk about the fact that you should be, first of all, viewing patients that are gonna be in a study, not as subjects, but as participants in the study, so the mindset thing there, which is very, very important. But also they talk about the fact that you should be working with patients and patient communities before you even start to design the study, to understand the architecture of what's going on, and then patients and communities should be involved throughout the process of the clinical trial from concept all the way through as partners in the process.

And then as you say, when you're coming to publication, it's very obvious that the person can be part of it. And to fulfill your guidelines, if we've been involved in the process throughout, then absolutely that person would be part of the publication and one of the leading authors, let's face it.

Rob: Yeah, and it gets back to those guidelines. They very much require that a patient is involved in the whole process, can 

speak to what's happened in the development of the research and so on. So, um, I think this conversation makes good sense in terms of how to best involve patients in this ecosystem.

Steve: The other thing I'd say though, Rob, is that that's for publishing clinical trial pieces. But a lot of medical publications aren't trials, they're opinions, they're reviews, et cetera. And there is no reason that a patient can't be involved in that or even leading those things.

Rob: See, I really like that comment because you know, if you don't have an opportunity to include a patient in the publication of the major clinical trial– it just doesn't make sense or they don't meet the criteria– it's not like that's your only opportunity to get them involved in part of the broader publication plan to get that perspective out there. However, I do think it's a miss based on our conversation, um, to have these clinical trials published without a patient perspective. SoI hear where you're coming from.

Steve: But I think there’s a separate thing. There's two of the pieces that I've, recently, one that's been published and one that's going through peer review at the moment. They're opinion pieces of, for example, the nocebo effect, and how that works in practice and why, why we should consider it in clinical practice, and that's a piece that I've written with a psychologist. But I'm the lead author on it 'cause it's my concept.

Rob: Yeah. Well, then that makes sense. 

Steve: But, there's no reason why a patient shouldn't be a lead author. The difficulty with all of that then becomes, you know, to get it in an open access journal, it will cost me $3,000 to $5,000. I don't have $3,000 to $5,000 to publish. That makes it hard.

Or I publish it so it's not open access, and then people have to pay to see it, which makes it inaccessible. The other thing that goes alongside it is for many of the publishing houses, you have to be allied to an institution, a recognized institution, to be able to publish, and actually, that makes it very difficult for a patient to be able to then be an author on a publication, especially a lead author.

Rob: Yeah, and you're getting into an area that I really, um, I did want us to dig into a little bit, which is the barriers. You know, there's definitely a difference when you're working as part, let's say, of a big biopharmaceutical company, and you're doing medical publishing there. But a patient out on their own trying to get their perspective on something, there's a lot of challenges nowadays, especially when it comes to accessibility.

Are there solutions that you have in mind? Like if a patient is out there trying to publish perspectives or one of our listeners is trying to advise, you know, suit up  their publication plan to manage this problem, what do you say they should do?

Steve: It's a really good question. Um, I think first of all, being receptive to patients and the value of a patient as a lead or through. In most disease areas, there's such a validity to this, especially if you're looking at some of the rarer diseases, which we do thankfully talk about a lot more now. Um, so I think maybe a more flexible approach to publication. So you could say for your journal, there could be X number of articles, but say X number of articles per publication or per year where you make them part of your pro bono work, where you say, "Actually, we will encourage patient-led pieces, and they can apply to be a free publication." That could be a way to do it. Um, I know that there's a publishing house that has just given me free publication as open access because of the value. Validity, again, is a word I've been using a lot in this, but it does, does come quite, quite relevant. Because the piece that I 

proposed was so important and actually made a difference for medical practice from a patient perspective, they said, "We will waive the fees."

But that currently is ad hoc, and I think it should be something that's more processed.

Rob: Yeah, those are isolated successes, unfortunately, right now, and hopefully that'll generalize to more. But I do think having conversations like the one that we're having today, at the very least raises awareness, you know, 'cause I remember being in the trenches, and I remember doing publication plans and leading teams to do publication plans, and, we would, again, talk about patient centricity or integration partnership, but really making it happen is something that I think becomes an afterthought many times. Like, we've got the publication done, maybe let's run it by a patient and see if it seems to resonate. What I hear you saying is that's an old-fashioned way to do it or maybe not the best practice when we want to really make sure we're reaching patients and their needs.

Steve: Absolutely. And the way to, again,there is that mindset thing. We talked earlier on about the importance of, uh, seeing patients as being partners within the process. But actually, if you are partnering with the patient community throughout all of your work in research, in developing best practice, in writing guidelines, you know, there are UK guidelines that I'm involved in, the construction of them at the moment as a patient expert. So all of these architectures having patients embedded means that then when they're being published, of course the patients will be part of the publications.

Rob: Yeah, it makes good sense. It's almost just intuitive. It's almost ironic that we need to have this conversation. But I think, I think it does help to raise awareness, And the other reason why I like this conversation is, you know, our profession right now is at a time where it's going through some transition 

and, some of our folks are struggling to find where we bring value and they're looking at, like we said, machine-readable and so on. But I feel like this is an area where having awareness and being a champion in our organizations is a good way to show another form of value for being a publication professional.

Steve: Uh, absolutely. I think that there is such an important role of these publications and publication professionals in countering misinformation, which is rife in the medical community at the moment.

Rob: Yeah, and I think that's a good way that I think our listeners can bring value tomorrow, and they're working alongside their medical information colleagues and their field medical people and medical directors. But this is an area where just raising the awareness and allowing publication, medical communication professionals to be a champion for patient involvement, I think is a really, really good way to raise awareness in organizations and also bring broader value for the profession.

I like it. You know, before we, um, we conclude, I wanted to ask you, sometimes we talk about ethical issues in patient publishing and things of that nature. Are there any comments you would make around good ethical practice when it comes to working with patients in publishing?

Steve: Respect is probably the key thing. Seeing patients as being not an afterthought, as being an integral part of it, respecting the input. Seeing us as being a voice at the table, And I think that's an important thing to reflect on actually because a meeting I was at recently, I was presenting and there was an oncologist in the audience who was part of, part of the meeting, and he came up with a question.

He said his worry about this approach that we're taking with the patient voice, et cetera. He said that sometimes that voice may 

be wrong. And I said, "Absolutely, we're not, we're not talking about the 1970s, 1980s customer is king approach here. We're talking about the patient having a voice at the table, and so long as the voice is heard is what really, really matters."

If the suggestion actually turns out to be something we're not doing. Recently in a study I said my opinion.I've got to be careful because it's a piece that we're working on at the moment; we've just got the grant in. Um, butI suggested a different approach but they actually went and worked on it, and they came back and said, "Actually, this is the reason why we think we should probably go with a different approach to what you said.Is that okay with you?" Of course. If they just turn around and say, "You don't know what you're talking about," that's not okay. So but  that's respect, as I say. It's an equal voice at the table.

Rob: Yeah. And as you're saying, it's a patient perspective, not a patient mandate, right? 

Steve: Yes. Lovely. Yes, I like that. I'm gonna steal that.

Rob: You can have it. You can use it. Absolutely. Absolutely. All right. Well, as we round it out, one last difficult question for you is, so we're looking five years ahead now, and we're, you know, still continuing on the track.What does success look like in this area when we talk about patient centricity, patient partnership? Um, how does the world look in five years if we've done a good job?

Steve: Pretty much every publication should have patients in them, as a collaborator in the piece.

Rob: I think that's well said. I think that's an admirable goal, you know,I think having at least some perspective, even maybe sometimes byline authorship where it's appropriate, I think that's an important goal.

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