Garth Sundem   00:00

Welcome to this episode of the Medical Affairs Professional Society podcast series: “Elevate”. I’m your host, Garth Sundem, Communications Director at MAPS. And today we’re speaking about embedding communications in real-world-evidence strategy with experts from IQVIA. We have Becky Galbraith, Senior Director IQVIA Medical and Patient Communications. And Barbara Arone, VP of Medical Affairs Offerings. This episode is sponsored by IQVIA with a mission to discover previously unseen insights, drive smarter decisions, and unleash new opportunities. So, Becky and Barbara welcome. So, I’m excited today, because I think we have spoken about RWE from some different angles, but not embedding the angle of communications. Barbara, could you get us started by talking about why RWE is becoming so much more important now.

Barbara Arone   01:03

Yeah, it’s a great place to start the conversation. So, we have when you think about the use of RWE and the lifecycle in drug development lifecycle and product development lifecycle. And then, and then, in the usage phase, we used to talk about real world evidence just at the end of the story. We talked real world evidence when products were on the market, and we thought about communicating to patients and physicians and payers. And it was very much the end of the story. But real-world evidence increasingly inter-woven earlier and earlier in the development process. So, we’re seeing real world evidence that is being used by companies to help them plan their early phase trials. We’re seeing regulator accept evidence. So not only are we not only do we live in a society that produces more and more real-world evidence every day, everywhere we go, every Fitbit we wear, every time we visit a doctor. So, there’s an incredible abundance of real-world evidence. But we’re seeing a real openness to the use of real-world evidence in different places in drug development, and healthcare delivery. And so that’s really changed the conversation about where real-world evidence can be helpful. The other thing that we’re seeing is that the advancement in technologies, you know, I said, we’re creating a lot of real world data, every single day, every time you see a patient, every time you see a doctor, every time your step counter shoots your data off somewhere, we are creating a real rich, incredibly diverse set of data that we could capture to be able to do research and analysis and communication about, we’ve finally got technologies in place to help us harness that data in useful ways. So, adoption of artificial intelligence, and machine learning has really made those huge, vast chunks of data available for us to actually do something useful with. So, I think it is driven by the abundance of data. And by an acceptance that real world data is more useful or can be useful earlier in the development lifecycle. So those are sort of the two biggest drivers that we’re seeing about use of real-world data and communications.

Garth Sundem   03:23

Okay, well, before we move on to communications, I just wanted to follow up real quick. So, if, if RWE is moving earlier in the development lifecycle, how can we have RWE, before an emerging treatment is in the real world?

Barbara Arone   03:38

That’s a good question. Well, you know, if you look at so, my thinking around this is actually if you go to the rare disease space. So rare diseases have traditionally used real-world evidence early in the development lifecycle to help lay out the foundation for their clinical trials. Because you get those rare disease patients and you characterize what do those patients look like? What is their clinical course, what information is going to be useful when I’m doing my clinical trials to talk about efficacy of treatments. So, biomarkers and personalized medicines are essentially creating rare diseases out of more common conditions. So, it’s unusual for somebody to be pushing something through the development lifecycle that isn’t a subset of a population. And so those same principles for rare diseases are now being applied across a larger swath of treatment development, because we’re talking about maybe a patient with a common condition, but your product is for patients who are a subset they have a certain mutation, they have a certain biomarker or they have a certain characteristic, their x-line therapy, etc. So essentially, creating rare diseases out of these common conditions means that we need to understand what that person particular populations, essentially what their baseline is. And so, you can really use real world evidence to establish what the baselines are for those for that patient population earlier in the development lifecycle.

Garth Sundem   05:13

Boy, it’s like with rare diseases and personalized medicine, every disease is becoming a rare disease.

Barbara Arone   05:18

Exactly. Absolutely. Absolutely.

Garth Sundem   05:21

And so maybe we’re not developing these treatments and then saying, you know, here you go patient population, go try it. Becky, are we talking about communicating with patients, to, to generate RWE during development? I’m just thinking that this, you know, you’re not just looking at patient registries at this point, you’re talking about communicating earlier in the lifecycle as well, aren’t we?

Becky Galbraith   05:52

Yeah, so I think from a communication standpoint, the rise in real world evidence means this a broader range of audiences that we’re looking to communicate with than ever before. So, from regulators, who want to deliver products effective and safe to payers, who need to understand the value profile. Healthcare professionals, of course, want to add to their understanding of a product profile, above and beyond what’s been demonstrated in the RCTs in different geographies and different demographics and different patient subsets. And then as you’re saying, you know, as appropriate patients also become an audience for communicating around real-world evidence as well. So firstly, it’s super exciting to have so many different stakeholders that we can be thinking about to bring the value of real-world evidence to, but that’s in itself quite complex as well. Because you need to think about for each of those audiences, what is it that they are looking for? And what do they need to understand about a product profiling about the data in order for them to inform better decision making, so as communicators, then we need to make sure that we’re tailoring the communications that we are designing so that we’re really speaking to the right audiences appropriately, and talking to them about the types of questions, you know, that they have. And when we think about patients, you know, COVID, is a really great example of where real-world evidence is absolutely, you know, filtering down into patients, awareness and decision making. And we’ve gotten very used to seeing huge datasets shown to us on the news and on the internet, and, you know, on the radio, and so our expectations is, you know, consumers and patients are increasingly, what real-world evidence looks like, it’s no longer a kind of something that’s, you know, in the, in the darkness, or in the background, it’s something that we expect to see, and we expect to be able to understand it, and the communicators to help us to understand it. So, there’s great expectations there, I think.

Garth Sundem   07:53

Well, talk about a communications challenge. I mean, you know, people are making their individual decisions, certainly in the context of COVID. And I wonder if that’s gonna carry over into an even more empowered patients in, in, in the post COVID period as well for other diseases? So, you know, talking about involving patient communities and communication seems like a real, a real way of the future. Does this affect? You know, what, when do we start thinking about this? When does this start to affect our strategy?

Becky Galbraith   08:36

I mean, I’ll start on that one, because I think it’s an important point to raise that, you know, patients are, you know, an increasingly important audience here. But we do need to be careful and make sure that we’re operating within all the relevant, you know, guidelines about communicating with patients around particularly prescription medicines, medicines, in the various countries. So, we have to be extremely careful that we are communicating appropriately. But you know, I think considering how we might communicate with patients from very early on, in a communication strategy is key and you know, something, some really nice approaches that we can take alongside the more traditional RWE communications are things like patient lay summaries, so why wouldn’t we, when we’re communicating the results of a study? Why wouldn’t we write something that’s easily understandable by patients for them to be really aware of what that, what that data means, in an appropriate way? So, there are some ways if you think early enough, and you’re very aware of what’s permitted in each country, you can start to think about how to bring patients along with that decision making and that awareness of the data

Garth Sundem   09:43

Barbara, I see, I see you nodding heads, so communicating RWE. Are there specific challenges in communicating RWE or even emerging opportunities?

Barbara Arone   09:56

Yeah, so I mean, there are some, there are some challenges around communication for RWE, I don’t necessarily think that it is easy or harder than any type of scientific communication. I just think it’s different. You know, the scientists and specialists that we involve when we’re communicating about RWE are different from the ones that we would use to communicate about a clinical trial result. And so, the use of epidemiologists who can help us interpret the data, in the context of the real world in the context of the population data are really important when we’re communicating about real world evidence. So, you know, there are, there are some components from a scientific standpoint about these communications. The other thing is that we want to make the real-world evidence as accessible as possible. And we want to be able to help people really understand not just what does this not just what data have we gotten? But what does this actually mean? How can we interpret this in a larger population setting? So, I do think that there are some unique challenges to real world data. That’s why That’s why we really like to try to think about the communication of real-world data early in the process. So, we tell companies, when they’re putting together their evidence generation plans around phase two, for what your future evidence needs here, at the same time, as they’re putting together those evidence generation plans, they should be thinking about the communication, there’s, like, there is no point in generating evidence unless you intend to use it somehow to communicate to the world about your, about what you have done. And so, we really talk to companies about bundling those two things together, an evidence generation plan it I mean, and then some companies, it’s complicated evidence generation, evidence dissemination might be handled in two different parts of the organization. But if you’re talking about evidence generation, you should be very quickly talking about evidence dissemination afterward. After all, that’s that that’s the purpose. That’s why we’re trying to amass all this information to begin with. So, I never think it’s too early to talk about evidence dissemination.

Garth Sundem   12:04

That’s interesting, you bring up a good point with expert identification to that we’re talking about some new people here, you know, used to be just the oncologist presenting at ASCO, you know, or the person who has the most clinical trials or the most publications. But you’re saying that communicating RWE, you may be looking towards epidemiologists? Or what maybe people in the public health sphere more? Or are we? Are we talking about different experts needed here with RWE?

Barbara Arone   12:36

I think so. And I’m interested in Becky’s perspective on this as well. But I think so because there is, you know, if you think about looking at a data set, that is, you know, some of these COVID datasets, or 20, 3,0 40,000 patients, requires a special understanding of how to translate that data into something real, that doesn’t necessarily sit with every scientist that we’re used to working with for other medical communications. So really, an epidemiologist or a statistician who’s trained in methods for epidemiology are incredibly important to make sure we’re interpreting and communicating correctly. Becky, what’s your perspective on that?

Becky Galbraith   13:15

Yeah, I completely agree. I think I think, you know, the, some of the challenges that we can experience with real-world evidence communications is that we can come a little bit late to it. And so, one of the pitfalls that we sometimes see is the evidence is, you know, designed and generated, and then we find ourselves starting to think about how do we then communicate it using input from an epidemiologist and statisticians, etc, and designing that communication. However, if we’d have thought about that a little bit earlier, we might have been able to think about some of the complexity of the design of that study in the first place. So, what were its objectives? What was it setting out to establish? Why did we design that real world evidence generation initiative in the way that we did? Why did we select the data, the data set? So, the data approaches that we did and, and why did the epidemiologist and the statisticians analyze it and interpret the data in a certain way. And if we can do that early enough, it helps with the transparency of the real-world evidence generation process, it helps to, helps us to be clear of why we undertook the study in the first place, and why the methodology that we selected was the right one. That then helps us to be really clear in the communication of the results later on. It helps to build understanding of where those data fit in to the wider picture. And it also helps us if we’ve had that due diligence earlier on in the process by working with the statisticians and the epidemiologists. On, you know, how can we articulate what you’ve been doing more clearly, that then helps us we start to think about publications. And as we get to things like peer review, a lot of the potential questions that a peer review panel might ask, why did you structure it this way, have been well thought about and well described. And that then helps us with the communication And later on. So, it’s about involving these different sets of expertise to analyze and contextualize the data. But it’s then working with them to help us to communicate that every step of the way, rather than post hoc.

Garth Sundem   15:12

Yeah, it’s funny, I was chatting with rare disease folks just last week, and they were saying that one big challenge in Medical Affairs is that you don’t only have to message your, you know, safety and efficacy, you may have to message how a gene therapy works, for example, or how your treatment works. It seems like, do we in industry need to with RWE, not only be communicating the results, but be communicating how we did our studies and why that makes RWE results valid? Yes,

Barbara Arone   15:54

I think selling gene therapy is an excellent opportunity for us all to think about how we communicate about what, how we communicate, and about what treatments and about treatments and how they actually work. That, you know, the COVID vaccines taught us that, you know, there’s a lot of there’s a lot of confusion about what’s actually happening from a biological standpoint with the COVID vaccine. So, I do think that that has opened our eyes for a lot of the cell and gene therapy work to think about how to best communicate to people what the actual function of the treatment is. And that is, you know, from a real-world perspective, that’s not necessarily real-world data. But it certainly is real world communication. So, it certainly is an opportunity to say, you know, is an average reader going to understand this piece of information. And I think that’s another place where that’s another place where communications and evidence dissemination hits up against the public, which, you know, our brave new world, people have access to incredible data sources that they may or may not understand. And so, I do think that that might change the way we think about medical communication and communication about treatments to make sure it’s understandable in the, in the general population.

Garth Sundem   17:11

And I was thinking more do we have to communicate how real-world evidence works? So that as we, as we go out with the findings of real-world evidence, people believe it?

Barbara Arone   17:22

Yeah, yeah. Yeah, that’s a good point, too. That’s a good point to getting that sort of establishing, I mean, and when you’re establishing how real-world evidence works, of course, you know, there’s benefits and limitations to any study design, whether it’s real world or interventional, traditional study, there’s always going to be benefits and limitations. So, I do think that that that that is part of the communication is, is just show how, how you are learning something unique from real world evidence, but how you are then in exchange, giving up the controlled environment of a clinical trial, so.

Garth Sundem   17:54

And, Becky, have you found resistance to, when you go out and communicate real world evidence, do you find that there are barriers to belief that may not be there for an RCT?

Becky Galbraith   18:10

I think that’s an interesting question. And I think, you know, there is work to do to make sure that the, the perceived rigor and transparency of real-world evidence come through really clearly in the communications of those data generation initiatives. So, you know, with RCTS, for example, the methodology is very clearly explained that the results are very clearly explained. And with real-world evidence, we should apply the same rigor, we should make very clear why that study is being undertaken and what its objectives are, we should be absolutely transparent about the methodology that’s been employed in why and then the data and the results should be communicated. So that we can then you know, make sure that there is transparency and that credibility, and that the, you know, the data that has been generated is offered through peer review to the clinical community. And that is, that is the right way to then overcome any barriers about the seed value of real-world evidence if whereas, apply as much rigor and transparency as you’d expect from an RCT communication.

Garth Sundem   19:13

Well, I think it’s so interesting that RWE is not just, here is the treatment in the real world and let’s see how it works in various patient populations. But that using RWE earlier, can put the patient at the center of development that requires, you know, again, that real-world understanding, but also that two-way flow of information and communication with the patients and everyone in these ever-shrinking disease communities. Well, so thank you, Becky and Barbara for joining us today. To learn more about how your organization can partner with IQVIA, visit iqvia.com That’s IQVIA.com. MAPS members, don’t forget to subscribe, and we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series, “Elevate”.