Overcoming Barriers to Make Patient-Partnered Research a Reality

Host Dr. Davide Soldato and guests Dr. Suzanne George and Liz Salmi discuss their JCO article "Overcoming Systemic Barriers to Make Patient-Partnered Research a Reality"

TRANSCRIPT TO COME

Dr. Davide Soldato: Hello and welcome to JCO’s After Hours, the podcast where we sit down with authors from some of the latest articles published in the Journal of Clinical Oncology. I am your host, Dr. Davide Soldato, Medical Oncologist at Ospedale San Martino in Genoa, Italy.

Today, we are joined by JCO authors Liz Salmi, Researcher and Patient Advocate, and by Dr. Suzanne George, who works as a Medical Oncologist at the Dana-Farber Cancer Institute where she acts as the Chief of the Division of Sarcoma. She is also Associate Professor of Medicine at Harvard Medical School. Today, we are going to discuss with Suzanne and with Liz the article titled, “Overcoming Systemic Barriers to Make Patient-Partnered Research a Reality.”

So thank you for speaking with us, Suzanne, Liz.

Liz Salmi: Thanks for having us.

Dr. Suzanne George: Yes, thanks.

Dr. Davide Soldato: I just want to make a brief introduction because I think that the concept of patient partner research is very wide and I'm not sure that all of the readers of JCO really have a deep understanding because I imagine that there are a lot of ways we can involve patient and patient advocates in the research process. And so I was wondering if you could give us a little bit of an introduction about the concept.

Dr. Suzanne George: Sure. I think the point that you raise is really important because there are many terms that are used, patient-partnered research, patient advocacy, but I don't think that there's a single definition as to what that actually means. In the context of our work, we’ve sort of summarized our experience through something called the PE-CGS or the Participant Engagement and Cancer Genome Sequencing network. And in that project, which is a Moonshot funded network, the intention is to have participants in research be true partners working with traditional academic research teams in order to develop networks specifically focused on cancer genomics. So what we've done, every center is a little bit different in the network, but we're really having research participants not just act, but really work on the research team from the beginning of the project inception all the way through the research project.

Liz Salmi: What brings me to the PE-CGS network is my 17 years experience as a person living with a low grade glioma, brain tumor or brain cancer and involving patients in the co-design of research is super critical because patients bring unique lived experiences that can shape research questions, study designs and outcome measures in ways researchers might not anticipate. And we're finding this through our network. So through my work, including my patient experience and brain tumor focused study designs, I've seen firsthand that patient insights can drive more practical implementations that ultimately benefit both patients and the researchers. And so the particular project I work on in the network, we've got like five different arms and different groups of cancer types that are being represented, so I'm basically focusing on the OPTIMUM study around how brain tumor patients can help in this study design. So in this project I serve as not just a participant in the research, but also as a patient co-investigator.

Dr. Davide Soldato: That is very interesting. And I think that we really captured the essence of patient-partnered research by having both of you here talking with us about the PE-CGS. And the second question that I wanted to ask is: I really think that the network focuses on something that is quite important right now and currently in medical oncology - so cancer genome sequencing, access to novel therapies - and I think that it's really challenging to imagine a way in which we can really get our patient and get patient advocates to help us designing new trials who are looking into this. And I just wanted to know, do you think that there is something that is particularly challenging when we are speaking specifically about cancer genomics and access to this type of drugs that are targeting specific molecular alteration? Because I think that in general it might be a little bit easier, maybe I'm biased on this, so you can also tell me if I'm wrong, but I think that it's a little bit easier when we are trying to design, for example, behavioral intervention or things that are more commonly found in oncology and a little bit more complicated when we are speaking about genomics.

Dr. Suzanne George: So I think that's part of what this network is trying to address, which is really what are the barriers and the opportunities around cancer genomics from the patient perspective and how do we make sure that that perspective is included as we're thinking about study design and inclusion? As Liz mentioned, this network has five different networks within the network, five different centers, and each center is slightly different with the population that it engages with. And so there's diversity there in terms of reaching out to different patient communities and partner communities around potential barriers for genomics research. I think one of the things though that we're finding across the network is that people want to be part of this work. People that have a lived experience of cancer want to help move the field forward. And what we ended up writing about was some of the barriers that get in the way of that. It's awesome to have people like Liz that are like all in and then there's people who are on the other end of the spectrum that want to share their information to help move the field forward around genomics, but then there's all these barriers at the systems level that get in the way of that. So I think that that's one of the challenges we're trying to overcome and learn about across the network.

Liz Salmi: Yeah, I think I bring this really interesting, I can't say I'm really interesting, but I think I bring this really niche perspective. Not only am I a person living with a brain tumor and I'm a co-investigator but also like a participant in this study. I also, in my day job, I'm an investigator as part of the director of communications and patient initiatives on the OpenNotes lab at Beth Israel Deaconess Medical Center. And our lab really focuses on how open, transparent communication between doctors and patients improves care. And that's been going on for longer than I've been around on our team. But what I bring to that lab is I focus on engaging both patients and clinicians in spreading the awareness about the power of how easy access and transparent communication, access to information across healthcare settings helps patients feel more involved and informed in their care.

And I work specifically, it's a really niche area. I work on projects that aim to expand access to notes and test results in diverse care settings, really helping tailoring initiatives so that various patient communities can understand how they can be involved in these types of research projects. Ultimately that's what brought me into this space. I might be one of the first generation of patients that actually starts helping co-design studies on things like this. And I think that across a lot of healthcare settings cancer is really what we're focused on. But patients are now increasingly being involved as research collaborators. And there's many different funding institutions such as the NCI but also PCORI they now mandate that funders reflect a shift towards more patient centered research frameworks. So it's like the PE-CGS network isn't the only group that's being funded to do research in this way. And I think other investigators, even outside of the cancer space, but specifically in cancer, need to learn how to do research in this way.

Dr. Suzanne George: Yeah, I agree. And I think the other thing that we need to do is if people want to participate and that participation in many of these networks has to do with record sharing and data sharing, the system needs to accommodate that. If people want to share their information in order to allow research to be performed, then we need to make sure that that can happen, and that it's not that the institution systems don't connect with someone else's systems or that you to pay X, Y and Z dollars for the data to go A, B and C, or that some places are on this EHR and some places are on that EHR and so, sure, you can share it, but you have to go through all of these hurdles in order to make it happen. When a patient signs a consent form that says, “I want my data to be used,” we as an investigator community, we owe it to that patient to make sure that their information is being part of the data set that will be used for learnings. And that's part of what we wrote about, is the lots of behind the scenes things that just get in the way and that we need to work towards improving.

Liz Salmi: Both Suzanne and I are really passionate about this stuff. And as a person living with a brain tumor for the last 17 years, I'm a chronic research participant. I always, always, am really curious. I'm like, “Yes, let me contribute my data. Whether that's electronic health record data or maybe I'm being interviewed about certain aspects of the cancer care experience.” And the one thing that bummed me out for like the first 10 years of being this chronic research participant is I would enroll in things, I'd be interviewed for things, I'd fill out these surveys and then I never heard anything about what happened with that information and that time I spent. And people would send me like a $10 gift card to Amazon, like, “Thanks for participating,” but really what I wanted to know is like, did you do anything with that? How did that inform things? So that really annoyed me to the point where I was like, I'm just going to be part of the research process and really figure out how we share that information back to everybody who had spent so much time. And so my participation in this space is like, “Let's change it. Let's give people information back.” And now I know it takes a really long time to have a finding that could be published somewhere that we then get it back. But closing the loop on the communications gap is something I'm really passionate about.

Dr. Davide Soldato: Do you think that we are changing a little bit this perspective? I feel like we are getting a little bit better in creating patient communities of patients who are included in specific clinical trials. And then we do the effort of creating a community, of keeping people really involved with the research that they are participating in. I think that we are not quite there yet, but I think that we are making some kind of steps in that direction. For example, trying also to inform patients to participate in the study when the publication that is related to that specific study comes out. What is the benefit? What have we discovered? I think that we are not quite there yet. There is a lot of room for improvement, particularly in the way I think we communicate these to patients who participated in research. But I have the impression that we are making some steps forward. So I don't know. Do you share the same thoughts?

Liz Salmi: So Dr. George talked about the PE-CGS network and then there's five different cancer types being studied. So the thing I can reflect on is what we've done in the, this is a really long acronym but, Optimizing Molecular Characterization of Low Grade Glioma. Say that 10 times fast. So our particular group is people who donate tissues about their brain tumors. We're really collecting data from people with multiple brain surgeries over time, which is really complicated and to make that process easier. And then once those tissue samples are stored somewhere, studying that information about what changes in the brain tumors over time and then also giving those results back to people so they can take that research level data and bring it back to their neuro oncology team and say, “Hey. Here's what I found out, “and having a conversation.

So, this is a long multi touch point study and in order to do that, to even make that possible is the individual patients need to understand what's in it for them. They're donating precious tissue in order to make the research process work. And so in order to do that, it's not just the investigators saying, “Hey. Give us your brain tissue, peace out.” It is we have a whole research advisory council of people living with these particular tumor types who help us co-design how do we do that outreach, how do we explain why this is important, or how do we message the importance of this work so they understand,“Oh, this is what's in it for me and this is what's in it for other people like me.” And from there then with that process, which again I mentioned, all of these multi-step processes, once we're able to understand how patients want to hear that information, what's in it for them, then we bring it back to like those bench scientists, investigators going, “Okay. And here's how this workflow should work for the patients,” and design everything around the patient experience before we even care about what's happening from the scientist researcher perspective.

Dr. Suzanne George: I agree. I think to your point, I think the fact that we're all here today talking about this is just like you said, is that we are making progress, right? Like we're even here having this conversation. Just like you said, I think there's opportunities to improve and further refine the communication and the involvement back in the patient community. When I think- if I put on my clinical investigator hat, I'm very involved in PE-CGS, but my primary research interest historically has been clinical trials and drug development. And I think that our approach in communicating results back has just not been consistent. But I do think that there's opportunities, just like you said, to provide summaries of information to loop back. I don't think that we've completely solved: What do we do? How do we provide information back to loved ones of patients that may no longer be alive that participated? How do we provide information to people who maybe we don't have their contact information? What if we lose track of them? How do we also make sure that we give people the choice to know? Do you want to know about this or would you rather just participate and then give space to that research? Because maybe that's how people's best for them. So I think that you're right, we're making progress, but I think that there's also a lot more that we can do. So I'm glad we're talking about it.

Dr. Davide Soldato: How much do you think that directly involving patients in this process, like asking them directly and co-designing the trial from the very beginning and understanding the level of information? This might also be another question inside of the question. So first, how much co-designing this type of research helps, and then do we also need to further refine at that level of communication, different communication depending on the level of information that different people want to have? Because I think that that's another level of complexity that we need to work towards at a certain point. We need to work on that first level of giving back the information. But then I think that there is also the other point of providing the information and information that should also be probably adapted to the cultural belief of different patients, to the ethnicity or to whatever cultural background or social background or whatever they may place their most interest in.

Dr. Suzanne George: So I think that you're 100% right on all of those points. I think those are all topics that need to be considered. We may be able to get to a certain degree of granularity around those communication points, but on the other hand, we also want to be able to communicate broadly and accessibly as possible.

One of the interesting things about PE-CGS, as Liz was mentioning, is each of the five centers has a slightly different focus. For example, one of the centers is focused on American Indians and Tribal Nations, and the communication practices coming out of that center are really unique and really very special and something that's been really, I think for me, very fascinating to hear about. Because to your point, like, just the strategy and what's considered appropriate is just different. I think if we hope to build a research world where our research participants and research data come from a broad swath of the population that really represents the population, the only way that we're going to be able to do that is find ways that bring meaning across the population as well. And that may be different based on where people are coming from and where people are at in their own journeys and in their own lives. But it's on us to be open to that and like to hear that, so we can do the right thing.

Dr. Davide Soldato: And I think that this is one of the objectives of the PE-CGS, really trying to bring this type of research participation to really diverse and underrepresented populations, not only in terms of cultural background, but I also think about different types of tumors. Like Liz was referring about brain cancer or low grade glioma, which is a very niche population. And I also think about sarcomas, for example, the degree of variability that we have in that specific type of disease is such that we really need to probably find different ways to communicate also inside of this diversity in terms of single patient and experiences, but also in terms of single diseases.

You were speaking a little bit before about the fact that the manuscript is really on the barriers that we would need to identify and then to change to make this system a reality. We were talking a little bit about consenting information and consenting the sharing of information, and I think that you make a very interesting point about the consent process when we are designing research. Could you give a little bit of your impressions about giving informed consent? What we need to change, how can we improve?

Dr. Suzanne George: The bottom line is the consent process needs to be simple, clear, and transparent. And sometimes I feel, because the traditional way that we've always gone about consent is frequently consent is as it should be in many ways. These consent forms are developed from a regulatory framework. What are we required to do to consent and how do we meet those requirements? Sometimes that becomes directly at odds with how do we do this simply, clearly and transparently? And I think as a research community, we have to be able to find a common ground there. That has to include regulatory requirements, that has to include IRBs. When we think about consents and work with our patient communities on this, everybody agrees the consents need to be more simple, except the IRB or maybe the IRB agrees, but it's this tension between how do we make it simple, clear and transparent and not get so bogged down in the regulatory that we lose that intent.

Liz Salmi: It's complicated. As a person, I mentioned, I'm a chronic research participant living with a brain tumor for 17 years. I remember enrolling in studies and seeing things that are just so complicated. I'm like, “Well, I'm just going to sign off.” I imagine somewhere somebody who knew more than me said, “I should just fill out this thing.” And then as I switched to the research world, I spent more time digging into, “Wow, this is a really complicated consent,” versus, “This is a really streamlined consent and I love this.”

And throughout my work with Dr. George and others on the PE-CGS network, an example of a good consent that's easy for people to understand is what the NIH All Of Us research project did, where they're trying to get a million people, more than that, signed up to be in this longitudinal study. And their consent is to go to their website and they have a whole bunch of short YouTube videos. There's a kind of like a quiz involved and they're animated, they have multiple languages involved. And I signed up for that study and I was like, “This is a beautiful consent.” And it's a very plain language. And more consents like that. If you're looking for a good example, go there. I have not been paid by them in any way. I'm a participant in their study.

I'm not sure if you guys and your listeners are aware, but there was I think, October 19th of this year or 2024, there was a special communication published in JAMA on an update on the Helsinki Principles for Medical Research involving human participants. And what they're saying is an ethical update is patient engagement in research, which emphasizes the need for continuous, meaningful engagement with research participants and their communities throughout the research life cycle, before, during and after studies. And so this is what we're talking about here. And it's now been embedded in these updated principles.

Dr. Suzanne George: That's really great and I agree with you. I think the All Of Us consent process is very accessible. It feels like you can understand it. But the other thing is that, again, I also am not directly involved with All Of Us, but the other thing about it is that they also have a high-touch way to consent where they have navigators and people that will go into communities in a very resource intensive way. So there's all different ways to go about it. We need to find a way that we can balance the complexity around regulatory and the simplicity and transparency that we need in cancer research.

Dr. Davide Soldato: Do you think that in terms of patient engagement we are doing better in academic sponsored research compared to sponsored research? A little bit of a provocative question maybe.

Dr. Suzanne George: I think that's a really interesting question. I think this idea of participant engagement and involvement is being infused across the research community. And in part, the FDA has prioritized it as well. I think the industry sees the FDA prioritizing this as well. And I think that there are many companies that are involving participant and advocacy communities in different ways in the study design, in the study process early on. So I think it's happening.

Liz Salmi: I'll be spicy. I've been a participant, I've been an investigator, co-investigator on studies and I have been reached out to often by pharma of, “Hey Liz, brain tumor patient advocate, would you be kind of like the poster child of our study or be involved in that way?” And I personally want to have no work in that space. I have no interest. However, I am approached, and other people living with cancer have been approached, by industry about lending their likeness or being commercials. And I don't think there's enough education to patient advocates of what that necessarily means, pros and cons. But I also can't speak on behalf of all of the patient advocates who might want to see that's a way that they could lend their voice and advance research. I personally think that there needs to be more involvement from the academic side of creating spaces where patients can be involved in the co-design of research and they also get compensated for their time fairly at the same level or some version of it in a way so they don't just jump to the pharma side of things. But that's an opinion that I have. Opinions.

Dr. Suzanne George: I think it's really interesting the point that you make about providing more awareness or information about what it even means to do these things from a patient side. I certainly don't know that side as well, but I do see, often, the term patient advocate used very frequently in many different contexts that mean many different things. And I think that there's an opportunity there for understanding more about what that really means and what it can mean.

Liz Salmi: Yeah. We want to involve patients, we want to do patient engagement. The BMJ or the British Medical Journal, have this new policy in place for patients as reviewers of research. And what I find interesting with the BMJ is they also ask patients to declare their conflicts of interest. So this is kind of a new space. If you're involved in patient research or perhaps working with pharma, patients, if you're involved at that level, should also be declaring their conflicts of interest if they're getting paid by a pharma. Or do I have a conflict now that I'm doing this cool ASCO podcast? Maybe. But do we want to overburden patients with tracking all this information? So it's a new world. The more we have access to information, the more we share information, the more we can read studies and we co-design, there's a new space I think over the next 5 to 10 years where how do we define this in a transparent way.

Dr. Suzanne George: Yeah, I think you're right. I know that we're getting long, but I just want to say one other thing about that, which is that you're right. If we're bringing patients in to be partners, then we have to treat each other that way. We have to acknowledge- I think this issue that you raise about compensation and about paying people for their time or acknowledging people for their time, I think that's really important and very under-discussed. Liz and I were at the annual meeting for the PE-CGS and someone was there giving a talk about- this was a guest speaker that was giving a talk about a very large high impact grant and that included a patient advocacy kind of module, let's say. And they put in a specific funding and budget for that component that included compensation for the people- from the people in the advocacy community that were spending their time. And the PI of this project, again, not to get into the details of it, but they were sharing that they got a fair bit of pushback on that. But the PI pushed back and said, “Listen, we're compensating other people for their time. These guys, we want them to be partners, we need to treat them as such.” And I think that also again, kind of we're in a new space, but if we're going to do it right, then we have to acknowledge that we're partners.

Dr. Davide Soldato: But I think that maybe an experience like the PE-CGS probably can be also a network for expanding awareness for patient advocates and also for creating sort of a new culture about what does that mean and how can we also improve on that part. Because in the end, if we want to engage, we also need to provide patients with the instruments to engage in a way that we think it's both useful for them, that can make research better, but can also make them at the exact same level as everyone who is participating in that research, which I think it's the bottom line of all the concepts that we are discussing right now.

Liz Salmi: Yep.

Dr. Suzanne George: Yes, I agree.

Dr. Davide Soldato: So I think we have covered a lot of things. Just wanted to make one last reference to a point that Suzanne mentioned earlier, which is the interoperability of systems. And I think that when we come to the cancer genome, that is very important, being able to share information, especially for those diverse and less common cancer types that we were discussing earlier. There is a lot of work in gaining all that information and we need to be able to gather all of that information in the same place to advance research. You were mentioning before that the process is actually very complicated and I was wondering if in the network you are already working on some potential ways to address this type of issue.

Dr. Suzanne George: I think our first step is really just calling it out, acknowledging how hard this is and what the barriers are. Oftentimes I think in research, we don't talk enough about what our methodologic barriers are. We talk more about what our results are, but not like how hard it is. But like in our projects, the Count Me In project, my network that I'm involved with, we're doing rare tumors. We can only do the United States and Canada because of privacy issues. And we're doing a completely web based platform. So we have the technology. But the privacy laws are impeding our ability to involve other parts of the world. And even within the United States, it's not as easy as we would like to get records. For example, despite the fact that people are saying, “Yes, use my records.” But then it's like, “Okay. Well, that's not that easy. How are we going to get them?” We had to hire a third party vendor in order to get the records, in order to manage all the different consents and releases that were needed across all these different hospital systems. So I think the first question is just calling it out and then from there working together as a community to try to see what the solutions can be, because we need to come up with those solutions.

Liz Salmi: Yeah, we're in the same camp as Dr. George and the fact that of the five partners, we're not associated with one particular institution. So we can reach out around the country and get access to those records. And we need them at multiple points in time, over time and it takes a lot of effort and work. And it's not like you could just, say, call hospital A and they have all the information. It's like all of the calls to all of the other sites. And it's not just from one surgery, it's from two or more surgeries. But also the way that people stay involved, and, by people, I mean patients and family members, there's this promise that at some point you're going to get some sort of information in response. Like, it's the “what's in it for me?” aspect of it. We do interviews with those who've been enrolled in the study, those who could be potential enrollees in the future because they've only had one surgery. And what we're learning overall is there's this altruistic nature that people have of- they want to participate in the research because they're like, “Here's my horrible cancer experience. I know other people are going to go through this as well.” There's this guiding light of “I want to do something, and I'm not going to be the person that creates the cure, discovers the genome or whatever for this particular cancer type. But my little bit of participation in this multiplied by 20, 30, 100, 1000 people, is what is going to lead us to the next phase in development and is going to move the needle for this particular tumor type or other cancer types.” And so what I think the impact in this space and participant engagement isn't just something we figure out, like a little research method and a little finding for one small tumor type, it's like the methods to do that is the big impact. The method around participant engagement can impact even beyond the cancer community.

Dr. Davide Soldato: Yeah. As Suzanne was saying, we need to be in a system that really helps us and allows us to do that. So I think that you really have a lot of things to work on inside of the network.

Dr. Suzanne George: I think one thing that I would say is I think that this issue of interoperability is acknowledged as a challenge. We refer to several different initiatives across the US where this is supposed to ideally change over time. I think people want it to change over time. I think investigators at the ERTC want it to change over time. I think different countries are working on this. And I think, again, the first step is getting us at the table talking about it, and then figuring out ways to move it forward. And I think it's there. I think that there is the will. We just have to figure out the how and continue to work on that together, because there's just a tremendous opportunity. I live in the rare tumor space, and between the FDA and the EMA and the regulatory, the national and the international research groups, the patient communities, people want this to be solved and I do hope that we will be able to get there.

Dr. Davide Soldato: So I would like to thank Liz and Suzanne for joining us today.

Dr. Suzanne George: Thanks for having us.

Liz Salmi: Thank you.

Dr. Davide Soldato: Suzanne, Liz, we appreciate you sharing more on your JCO article titled, “Overcoming Systemic Barriers to Make Patient-Partnered Research a Reality.”

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DISCLOSURES

Liz Salmi

Speaking Honoria: Medscape. Research Funding (Inst): Abridge AI, Inc., Yosemite.

Dr. Suzanne George

Honoraria CStone Pharmaceuticals Consulting or Advisory Role Blueprint Medicines, deciphera, Bayer,  Lilly, UpToDate, Research to Practice, MORE Health, Daiichi, Kayothera, Immunicum, BioAtla   Research Funding Blueprint Medicines, Deciphera, Daiichi Sankyo RD Novare, Merck, Eisai, SpringWorks Therapeutics, TRACON Pharma, Theseus Pharmaceuticals, BioAtla, IDRx, NewBay Pharma, Acrivon Therapeutics   Patents, Royalties, Other Intellectual Property Company name: UptoDate

Stock and Other Ownership Interests Abbott Laboratories and Pfizer Recipient: An Immediate Family Member