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 discussing industry sponsored publications with Felix David, Senior Business Development Manager at Wiley, and a former Managing Editor of the Medical Journal Trends in Urology and Men’s Health. And Richard Donnelly, Professor of Medicine at the University of Nottingham, and Editor in Chief of Diabetes, Obesity, and Metabolism. So welcome to you both, and things in this field are changing. And I was hoping we could start out Felix, maybe with an overview of the changing publications landscape for peer reviewed content.

Felix David   00:49

Thank you very much, Garth, yes, I can jump straight into that. So since the widespread use of the internet, the publishing landscape has really drastically altered to adapt to it as a medium with his numerous channels for the instant dissemination of a vast and of course very rapidly increasing amount of research. When thinking what this will mean with peer reviewed content is important to flag that this does change between regions and disciplines. However, with a medical publishing in particular, peer review, papers still have a tremendous value to the healthcare audience. So while he undertakes annual surveys of our healthcare professional audience every year to assess change in content preferences, and the recent results demonstrate the peer review articles are self selected as the most valued resource in clinical decision making. However, the peer review publication is not without its challenges, so traditionally, it remains as a PDF and it has an abstract method results in a conclusion which has a structure which honestly hasn’t really changed for decades, if not centuries. The internet has of course increased the ways we can publish content, and it really does beg the question about if peer review articles do remain the best way to disseminate information, as there are a variety of other format types, for example, graphical abstracts, video and infographic summaries and plain language summaries that can also support the data publication process. In regards to the challenges of peer reviewed publications, our authors often flagged their main pain point around faster publication, better data and innovative ways to publish and collaborate on key research. In this regard, I have to say that open access has of course been one of the largest changes to peer reviewed publishing has made research much more accessible than ever before. While new systems such as Rex, which is the Wiley research exchange has made excellent strides in improving the article submission workflow for authors. One other big factor is that the corporative coexistence between preprints and peer review articles is also represented a huge recent shift in the landscape, accelerating dramatically in 2020, and 2021. And demonstration of the importance of the rapid publication to our authors. By way of example, in 2020, more than 200,000 peer review articles are published on COVID, and around 40,000 preprint on COVID. So it already represents a fifth of output. In summary of all of that the changing landscape for peer reviewed publications, medical sciences, in particular, is revolving around open access open data and better ways of supporting collaboration. Richard, would you say that that also seeing similar to what you’re saying?

Richard Donnelly   03:21

Yes, it is. My interest is, is around content and particularly industry related content that gets submitted to peer reviewed journals. And what we’re seeing is a greater variety of data sources that can be used by industry to perform various types of analyses to provide new information either about disease states, or about therapy areas, or indeed about what’s happening in real world clinical practice.

Garth Sundem   03:59

Okay, so we have this changing landscape in which we’ve had this very static format for a peer reviewed study that has been around for decades or perhaps even centuries, but now we have disruption in terms of, you know, the internet and potentially new opportunities that come along with that. So, Felix, what new opportunities are you seeing for publications groups, maybe specifically in Medical Affairs that are seeking to place their sponsored content?

Felix David   04:32

That’s a really good question. So I think that when considering publication, I will say the key struggle for Medical Affairs teams and authors alike is how to ensure that their research does actually make impact. For context, I think I’ve already mentioned that research is rapidly increasing, and more than 6 million postdocs and researchers published more than 2.5 million articles in peer reviewed journals each year, and this as the more than 50 million articles that have already been published. And this rate is actually increasing by about 5% every single year. Impact is therefore a very valid concern as it is very clearly impossible for a researcher to view all the related content in their field. As we’ve actually mentioned, healthcare professionals still self select that peer review articles are their most important tool for clinical decision making. However, in those similar surveys, the responses we’re seeing also demonstrate an increasing trend to highly rate the importance of supplementary materials such as infographics and videos and clinical decision making. Okay, this Yeah, this trend does make sense, of course, because healthcare professionals are notoriously time poor due to their clinical and professional work. And so interactive assets that can quickly summarize data into these relevant summaries, via via perhaps a graphical abstract video, or infographic, or even an audio version of an article are very useful as time saving tool. We are wildly work with our wildly editing services team, for example, to produce a range of digital assets that have demonstrated use by healthcare professionals alongside a comprehensive marketing strategy to ensure the impact of published research. These assets themselves often embedded within the article and they will be a key opportunity I would recommend for Medical Affairs on their published data and what we usually termed as article discovery packages. So you can you can see where the name comes from?

Garth Sundem   06:18

Yeah, for sure. I was just gonna say impact would be the goal. And the opportunities are taking advantage of all these new formats. I’m sorry, keep going.

Felix David   06:32

Though. So that actually is on because I was going to flag that in future, I wouldn’t actually be surprised if the supplementary materials that we’re discussing now will actually start to supplant the article itself as the most access resource for education. So we’re actually the graphical abstract infographics and videos are really necessary tool within an article to actually ensure that the data makes the impact within the relevant audience.

Garth Sundem   06:56

Okay, interesting. So, Professor Donnelly, what opportunities are you seeing in this changing publications landscape?

Richard Donnelly   07:04

So I think the interesting thing, there are two areas I would highlight. Firstly, I think the audience is which access clinical academic journals in medicine are changing. It used to be that the audience was primarily healthcare professionals. But in fact, now, the audience for our publications includes regulators. It includes payers, it includes groups which are responsible for national and international guidelines. And it includes patients themselves, who are becoming much more armed and curious about good sources of information. So there is much greater variety of audiences who are looking for certain pieces of information that are relevant to them. The area, the second area that I see in development is the the move away from traditional randomized control trials as being the sole source of evidence about whether treatments work, and if they’re safe, and moving much more towards the analyses made possible around real world evidence. So healthcare systems around the world are becoming much more electronic, it becomes much more feasible to ask an intelligent question about what’s happening in real world everyday clinical practice, and to interrogate these databases in a way that provides very powerful information, because you can access information relating to large numbers of patients over long periods of time. And you can show quite interesting disparities between the magnitude of what’s perceived as a drug effect in a in a highly selected subgroup in a randomized trial, compared with a real world population. So we’re seeing much more in the way of submission and publication of real world evidence studies, which are very influential and very appealing to a number of important stakeholders and the audience’s that are referred to. So I think one of the big opportunities is to make use of real world evidence in order to engineer analyses that are relevant not just to healthcare professionals, but to those other stakeholders.

Garth Sundem   09:38

Okay, so we have new kinds of studies being communicated through new formats to new audiences. So when let’s switch over to the editorial side, Professor Donnelly, what are you looking for and what are editors looking for it? In industry submission to Wiley journals now or elsewhere, is it the same? Is it changing? What are you looking for?

Richard Donnelly   10:07

It is changing. And let’s start first of all with manuscript types. And, of course, traditionally, those manuscripts that have related to industry were the results of randomized controlled trials or possibly secondary or subgroup analyses of those trials, we’re now seeing an increasing trend towards publishing protocols, which is an important which is an important element of big RCTs. So publication of the protocol, or at least a manuscript which essentially is focused solely on the statistical hierarchical analysis that will be used when the trial is unblinded. So publication of the protocol is a very useful way of sort of declaring how the data will be analyzed before the results are then later available.

Garth Sundem   11:10

Let me just follow up on that really quick, is it? Is it important to publish protocols especially because there are new types of studies being done, like real world evidence, and now, you know, in order to interpret the I don’t want to say validity, but the validity of the data, we have to know how it’s being analyzed?

Richard Donnelly   11:29

Yes. And, and of course, let me give you an example from my own journal in diabetes, there was a very large cardiovascular outcome trial performed with an stLt two inhibitor known as the canvas trial, published in the New England Journal of Medicine. I own journal published the protocol and the statistical analysis of that trial, six months before the New England Journal paper. And when the New England Journal paper was published and presented at the American Diabetes Congress, of course, the discussion honed in very quickly on the mode of statistical analysis of some of the endpoints. And therefore, actually, it was very good for the authors to have devoted an entire manuscript solely to their intentions around statistical analysis, and to publish that ahead of the unblinding, which led to the New England paper. So that created greater transparency. It dealt with any suspicions that the statistical analysis had been adapted according to the results. And it was a very healthy way of of declaring intentions before results. So back to my original point that there are a variety of manuscript types that are now emerging. I’ve mentioned real world evidence studies, which I think will increasingly replace some randomized controlled trials, at least for regulatory purposes in the future. And those real world evidence studies are far more influential when it comes to guideline groups and others who are interested in compliance tolerability, effectiveness in the real world. And then mindful that the the inclusion exclusion criteria for randomised trials are getting ever more restrictive and selective such that those populations are no longer representative of the patients will receive a treatment. So So editors are looking for a variety of content that provides important relevant new information. Okay, that content has to begin with a clinically relevant question in the context of what’s not yet known in the literature, and importantly, introduced alongside what is known that that content, usually, for example, structured with methods and results and discussion has to provide some new analysis, some new results, and it has to be put together with a balanced discussion, which highlights the limitations and the strengths and the clinical relevance of the analysis that’s been been performed. What I’d also say sometimes is that peer reviewed journals are looking for the discussion of those analyses to be critical. And that is an honest acknowledgement of what the limitations and weaknesses are, as well as what the novelty and the Clinical importance might be. And sometimes I’d say that, you know, industry often makes use of medical communications agencies, in in creating manuscripts and interfacing with editors like myself. And sometimes those med comms agencies feel that they really have to please their employer, by conjuring up a lot of marketing messages, which they feel they have to sort of embed in the manuscript, at least eight times in case anybody missed them.

Garth Sundem   15:36

Interesting.

Richard Donnelly   15:39

And so, I would say to Medical Affairs professionals to really keep a close handle on your medical comms agencies, that they don’t feel somehow obliged to drift into the sort of marketing realms of imagination and get back to what can you honestly and robustly say about this data set. And let’s acknowledge upfront what the true limitations are. So the manuscript is constructed and presented in what seems to be a plausible, balanced and critical way. And those med agencies also sometimes feel that they’re unable to cite relevant literature that might have been sponsored by one of their competitor companies. So they might be presenting and communicating the study on a particular drug. And they have a competitor product from a competitive company, which has actually performed similar analyses in the literature. But but they try and pretend that they can’t really even mentioned that literature, or references, and that I have to say, causes a good deal of irritation to peer reviewers, when when the sponsor and the medical agency appear to sort of completely ignore, and elements of the literature, which is highly relevant to what they’re now presenting.

Felix David   17:11

I think that’s actually an important part to flag also for the supplementary materials, they also mentioned is that when we talk about sponsored content, we really refer to content that though is funded by the pharmaceutical industry remains editorially independent, so without any influence on the selection and creation of material. So all supplementary materials, for example, do need to meet the same publication standards as the peer review article. And this credibility is really vital, still achieve impact with healthcare professionals. So rich, and I have actually worked on this as well around bits in done around the sorts of infographics and videos that can be embedded to ensure that they maintain that level of editorial review and independence. They are correct assessment of the article messages.

Garth Sundem   17:57

Well, there’s about 15 things there that I’d like to follow up on. But I wonder if they, I wonder if many of these things that you’re looking for in a submission to a Wiley journal, could could be, could go under the umbrella of it used to be that a study would argue for its own validity, that it would say this is why what we did, you know, has importance, and here’s why you should believe it. And it seems like you’re saying now that articles are increasingly looking at their own, not their own faults. But you’re encouraging authors to not put forward the the narrative of why it’s such a big deal. But but to take a real look at their study and their limitations. Is that true?

Richard Donnelly   18:54

Yeah, I mean, I think all pieces of research can be interpreted up to a point and it with any, with any balanced scientific communication, there needs to be a summary of what’s original, what’s new, what the strengths of the analysis were, what the limitations of the analysis were, and how this how this research sits alongside other recent relevant literature, in terms of whether it’s consistent with or whether, in fact, it’s different from and and as long as that’s discussed in a balanced, comprehensive way that acknowledges the literature out there, including bits of the literature that might be uncomfortable to the sponsor, then then editors and peer reviewers will like it, because it begins with a clinically relevant question. So I I think there is something about how these these manuscripts are, are put together. And increasingly, and certainly numerically, there are way more sort of real world evidence type observational studies being produced and published these days than randomized control trials. So I think the the days of the randomized control trial are limited in many respects, because they’re, they’re becoming so expensive. They’re becoming so highly selective in their recruitment criteria, that they are of limited value solely for the regulatory audience, to demonstrate in a often in a placebo controlled fashion that a drug is safe, and it works. But what the payers want to know, which is really the next big issue, because we’re industry, as soon as you’ve got your FDA approval, hey, presto, you just handed it over to the marketeers to say whatever they liked. But nowadays, the payers are asking a separate set of questions to the regulators. And they’re trawling the literature and looking at journals like mine, to understand what is there out there to show me that this drug is actually effective in the store of patients that we want to purchase the drug for, which includes all those groups, the majority who were excluded from the randomized control trial, in that went to the regulators. So I think there’s great opportunity around real world evidence studies. And industry is clearly spending huge amounts more in funding to facilitate real world evidence studies around the world as more and more electronic healthcare records become more accessible and more joined up in order to ask some very powerful questions about the utilization of these therapies or indeed, to just get more information about a disease topic, you know, and, and true outcomes from a particular diagnosis.

Garth Sundem   22:25

All right, well, let’s leave it at that for today. And I would appreciate the opportunity to continue this discussion. At some point, authors, expand your imaginations and look at what you can do, not just with RCTs, and a PDF with your abstract methods, results and discussion, but all of these other features that go beyond in format and beyond in audience with a clear eyed look at the clinical relevance of your work and its limitations. So MAPS members, don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series: “Elevate”.