Empowering Clinical and Translational Research Across Northwestern with Leah Welty, PhD, and Anju Peters, MD

[00:00:00] Erin Spain, MS: Welcome to Science in Translation, a podcast from NUCATS, Northwestern University Clinical and Translational Sciences Institute. I'm your host, Erin Spain. This fall, it was announced that the NUCATS Institute received 55 million in National Institutes of Health funding to accelerate development, evaluation, and implementation of improved health care interventions. The seven year award is the largest research grant at Northwestern University and will allow NUCATS to work with community partners and health care systems to help build a better framework for innovating and Implementing discoveries and more inclusive ways. Today, we are thrilled to have two NUCATS members, Dr. Anju Peters and Dr. Leah Welty, on the show to discuss how this grant will help them drive the Institute's mission to support translational research through inclusive resources and innovative services in the years ahead. Welcome to the show.

[00:01:04] Leah Welty, PhD: Thank you.

[00:01:04] Anju Peters, MD: Leah,

[00:01:05] Erin Spain, MS: Well, let's get started by hearing a little bit about the two of you. Share a little bit about your backgrounds, who you are.

[00:01:11] Leah Welty, PhD: My name is Leah Welty. I am a professor of biostatistics and informatics in the Department of Preventive Medicine. I also direct our Biostatistics Collaboration Center, which is one of our core biostatistics resources for non cancer related research. I've been involved in the CTSA for a number of years, going back to the early rounds in the mid 2000s. And I am especially interested, both locally and nationally, on how we provide high level collaborative biostatistics resources.

[00:01:42] Erin Spain, MS: Dr. Peters, tell us about you.

[00:01:44] Anju Peters, MD: I'm Anju Peters. I'm a professor of medicine in the Department of Medicine. I'm also Director of Clinical Research in the Division of Allergy and Immunology. In addition for NUCATS, I'm the Director for Center for Clinical Research. And I'm the Medical Director of the Northwestern Medical Clinical Research Unit. I do research in chronic rhinosinusitis and its comorbidities, so I do clinical and translational research in chronic sinus disease as well as severe asthma and immunodeficiencies. And I see patients with all types of allergic disorders focusing more on severe asthma chronic rhinosinusitis.

[00:02:22] Erin Spain, MS: The two of you were brought together on this NUCATS grant to help lead initiatives, to enhance inclusivity and build better framework for innovating and implementing discoveries. So tell me a little bit about how the two of you came together. One, a PhD and one, an MD to tackle this issue.

[00:02:40] Leah Welty, PhD: We have really complementary perspectives and expertise. And clinical and translational research is complex, so of course it helps us to bring our different experiences together. Anju is really at the front end of the research. She's in the clinic. She's seeing patients. She knows how to ask clinically relevant research questions and really understands patients and disease. She knows the health systems and the patients in a way I never will. So her experience with patients and asking the research question is really what allows me to help answer them and people on my team. It's a perfect example of how team science makes translation possible. Partnerships between MDs and PhDs like biostatisticians are an essential element.

[00:03:26] Anju Peters, MD: I think we're the ideal team to lead the Clinical and Translational Sciences Program, just as Leah mentioned. You know, this emphasizes both the clinical part of it. In the end, if we do the right science, it benefits our patients, which I think is what the most important thing that we are doing.

[00:03:45] Leah Welty, PhD: We've done a lot of talking and getting to know each other and getting to know where our skills and expertise lie and how can we, you know, create better connections. And we're just discovering those. So I think that's one of the things that's really exciting that we'll uncover in the next seven years is we have This group of people in this module that have been brought together, everything from sort of supporting innovation to ethical research conduct, inclusive recruitment of participants and really cutting edge methods that, that way to thinking about sort of the rigor and reproducibility of the actual research process. There's so much we're pulling together and it's really exciting as we start to have all this cross pollination and people sharing ideas and thinking about, oh, we can do this team science thing here and we can bring this implementation science approach to rigor there's just so much possibility.

[00:04:39] Erin Spain, MS: Well, let's dig into some of the efforts that are part of this module. I know one is to enhance inclusivity of research participation. This has been a problem in the past. Dr. Peters, can you tell me a little bit about challenges that there have been in the past for inclusive research participation and what initiatives will take place to address some of those challenges?

[00:05:00] Anju Peters, MD: So, as you mentioned, Erin, it has been a big problem in the past and is still a problem. And the problem is that when we think of research, we want to be as inclusive and as diverse as possible. And the reason to do it is if we have it that way, then the research we do is more generalizable across all different populations. However, to do this, we have to make sure that different, you know, people of all races, people of different genders participate. Unfortunately, that has not always been the case and it may be because people don't trust research. It may be that people don't understand the research process or the consent or when we describe to them what a clinical research or translational research is about. We do have quite a few initiatives as part of our UM1 grant, and also as part of the Center for Clinical Research, which, as I mentioned, I'm the director of. One of the things that we've been working on for the past year, CCR is trying to bring translation services for our research, participants, and not just, translation to translate documents and consents, but also to have 24 hour in demand translation services. consultation available for our research participants during the clinical trial part for more than 300 different languages, this will make research available to people who speak different languages, so hopefully we'll get more people from other ethnic backgrounds. The second project that I think is very important is a project to improve consent comprehension. Many times our consents are very complex. People don't understand them, and if they don't understand them, they either will not participate in research or participate without clear understanding. So to help allow participants to make informed decisions, which obviously is really fundamental to good research. We're doing a consent comprehension project that we're working with our IRB, and we're collaborating with Dr. Mohamed Hosseini, who is a research ethics and integrity expert at Northwestern. Mohamed is focused on ethics of team science and ethical implications of using artificial intelligence in research and healthcare. So we hope working with him on this consent comprehension project that we improve consent comprehension for clinical trials. We build a more inclusive research environment, which is what our grant is about, and it'll advance, diversity, equity, and inclusion, especially for underrepresented population in many ways and then finally, you know, we at NUCATS partner, NCCR partner with our Trial Innovation Network, which the Trial Innovation Network is a collaborative network. It connects all the different CTSA research hubs throughout the nation, and it helps catalyze advances in clinical and translational science through multi-site trials. We at NUCATS are consulting partners for both Hopkins and Vanderbilt. For example, Dr. Catherine McCapagal, who's part Leah and my team on this UM1 grant, she provides consultation advice on research recruitment and retention. She's nationally known for her work in engaging and retaining diverse youth in translational research to the Institute for Sexual and Gender Minority Health and Well being. And she uses some amazing ways of doing this. She uses online approaches, social media outreach, dating sites, minority focused online marketing agencies, as well as micro influencers. She does this to help with recruitment and retention in research studies. And over the past year, NUCATS has piloted some of these consultations, including, through Lurie Children's, through Shirley Ryan Lab, as well as FSM. And we hope, as part of our grant, that we can expand this to others as well.

[00:08:51] Leah Welty, PhD: I think one of the places we're really hoping to see improvement and change is in inclusivity of our, both of our research participants, but also in the teams we have conducting the research. We really want to make sure that we're coming from all perspectives, you know. When we're thinking about partnering with community members and people in the community, it's about understanding their perspectives on what that research needs to do. So we're really hoping to build partnerships. , get it a lot more inclusion in terms of the whole group who's contributing. I think the more perspectives you can bring to how we ask the questions and what we need to do, it makes it harder because we're bringing in more diverse views, but it also makes it better in the end.

[00:09:44] Erin Spain, MS: Dr. Peters. I understand that there's going to be more opportunities for NUCATS members to receive some consultation services, to help them facilitate inclusion and do research ethically of diverse populations through something called the CREEC project. Can you tell me more about that?

[00:10:00] Anju Peters, MD: you know, so the CREEC program stands for Clinical Research Ethics and Equity Consultations. And really what this will address is issues of ethics as well as equity, both for research across the whole translational continuum here at Northwestern and throughout the lifespan of research. So the CREEC consults are directed by Dr. Seema Shah, who is an Associate Professor of Pediatrics at Lurie. She's also the Director of Research Ethics at Lurie Children's. She's a well known global expert on health research ethics, as well as Dr. Irene Blanco. Irene Blanco is a Rheumatologist in the Department of Medicine. She has done a lot of research on health disparities, and she will be the focus on equity. In addition, the CREEC program includes Dr. Aaron Paquette, who's MDJD at Lurie Children's and an expert also in ethically minded research to address bias and racism. So CREEC was originally actually introduced and piloted in spring of 2023. They offer consults, make recommendations, best practices to research teams throughout, as I mentioned, throughout NU, including Lurie Children's Shirley Ryan. They give a formal report with citations that requesters can then use to guide their work. This, I think, is a wonderful program and our goal through NUCATS is to expand CREEC services across NU with increasing both the numbers as well as the breadth of these consults. And the bottom line with these consult services is to facilitate inclusion and to do research ethically of diverse populations. Hopefully over time, we can also inform the rest of the CTSA network about the importance of designing and conducting research in this way, which enhances equity and inclusion across all research participants.

[00:11:55] Erin Spain, MS: So equity and inclusion is being addressed, but something else that's being addressed through this grant is enhancing rigor and reproducibility of research. And to do that, there's going to be the implementation of a software tool called stat wrap that was developed here at Northwestern university through NUCATS leah, can you tell us more about this tool.

[00:12:17] Leah Welty, PhD: StatWrap is our newest software tool. It's S T A T W R A P, so wrap like a rapper, not. What's the idea behind this? It really stems from my own research practice and integration in other research teams. And I think, you know, Anju can tell you too, research is getting increasingly complex as studies have more data, involved bigger data sets, more team members who have complementary but very different expertise. So for example, many of our studies here include a physician, at least one statistician, maybe a research project coordinator, laboratory scientists, maybe a study nurse. And they all come to the project in different phases and in different places. And so, you know, the people who collect the data may not be the same people who are analyzing the data, and then they may not be all the same people who are interpreting the results. So there's just all these people moving in and out of a project, and there's so many handoffs where If you lose track of the information and the documentation, you may really have misunderstandings or holes in your research. So that's what we're trying to do with StatWrap: it's a non-invasive discovery software tool that can help teams or even just individuals document workflows. It's free, and it's open source, and so we think of it as a way to wrap your research project together. So, for example, One of the things I really like about it is, you know, when we have complicated projects, we may have many data sets and we may have many code files for analyzing those data sets. StatWrap creates a map of those so I can see what code files use what data sets and what code files refer to each other and I can see what type of software we're using, if it's Python or R or a combination of those two. So it kind of creates this map of all the things that might be happening. Another thing is, it does is you can see who worked on a project over time. You can add people. And then those people can all leave notes in the project. And so they can leave notes about a file and say, Hey, this is actually the data file we want to consider is the frozen final data file. There are others, but these are not the ones we want. That's all searchable then in this program as well. So you can sort of go back and say, what are the things we noted about how we're coding this variable? Things like that. Our newest feature that we're about to put out is actually a checklist that is generated from the information in StatWrap, and it's sort of automatically generated, but can also be enhanced with information from the people using StatWrap to kind of say, this is a checklist of where we stand on our rigor and reproducible approach in this project. So it's out there, it's on the web, we're really excited for people to try it out and use it.

[00:15:12] Erin Spain, MS:  Northwestern has a rich history of studying the science of team science. How will we integrate team science toolkits and educational resources across NUCATS programming?

[00:15:17] Leah Welty, PhD:  So there's a couple ways. We're planning to build on that exciting body of research. The first one gets back to this theme of inclusion that we've been talking about. So we have, of course, a lot of active research teams here in our academic environment, but we are also trying to develop robust, productive partnerships with communities, um, and community partners, community hospitals, community health systems, more rural health systems. And so the team science toolkits and lessons we've learned are being adopted to support partnerships between Northwestern and some of our community partners. So we can really sort of help those groups grow and thrive and do exciting work. So really with that inclusion theme and building on a lot of what we have. Then within Northwestern, we already have a couple of touch points where we're bringing people together. So for instance, where MDs end up talking to PhDs like Anju and I do all the time, we have our Biostatistics Collaboration Center, which I direct. where we have a lot of, you know, residents, fellows, faculty, physicians come in and talk to us during these initial consultations. So we have these touch points where we're starting to build teams and we're thinking about how can we take some of these lessons from the team science toolkit and actually sort of embed them in those initial consultations and conversations. That we're giving teams sort of the best opportunity to develop. And the same is true for what we call our dissemination and implementation consult service. So it's a very similar model where people submit a project, they go and talk to an expert in dissemination and implementation. But this is also a place where we can think about, you know, inserting some of those important nuggets for building good teams.

So there's going to be many programs, short courses, materials, forthcoming. And at the same time, there's this innovation engine that's really revving up at NUCATS right now to help faculty lead startups and become academic innovators. Can you tell me a little bit more about that, Leah?

 Faculty at the early stages of innovation, let's suppose they think they can develop a device, or they have a prototype device, or they're thinking about securing a patent. They may not know what next steps to take. They may know the next NIH grant to write, or what experiments could give them the next results, but they may not know how to start to move that towards being in the public realm, being commercialized, being patented, being, manufactured. And so the innovator access program will include a consultation service for faculty where they can have office hours or even just have a consultation so they can find out more about what those next steps might be. It's also going to build a network for them so they could talk to other faculty who've been through the process or even things like the Chicago Biomedical Consortium, um, to get sort of broader advice. the ideas that they may come away with, like a pitch deck, or an IP strategy, intellectual property strategy, ideas for key experiments to make the project look more viable to potential funders, as well as a list of potential funding sources.

[00:18:47] Erin Spain, MS:

Lot of what you have both talked about today are ways to improve the research enterprise from beginning to end and how NUCATS is planning to do this. Is there a message you would like to leave NUCATS members with today? As we wrap up this episode and you to continue on with the work that you're doing as part of the grant.

[00:19:07] Leah Welty, PhD: If you feel like you see part of the research process that's working really well, let us know. If you're using some of our resources and services and they're useful, let us know. We need to have that information so we can keep supporting them and developing them. At the same time, if you feel like there's something that you need and isn't part of the game plan, let us know. Bring it forward. Let us know what that looks like. We also know what our section looks like, but in other pieces of the grant looks like, and you know, if it fits into the mission of NUCATS, I think we'd be pretty interested in figuring out how we can make it happen and, and how we can make this enterprise work better.

[00:19:55] Anju Peters, MD: I had the benefit of NUCATS to help advance my career, but it's interesting that I now am working with Leah on this part of NUCATS UM1 when I started. I didn't know much about clinical and translational research. I started with the MSCI class and learned a lot and now I get to do so much research and work with people like Leah and the rest of the team. Very different than what I do in my regular work as an allergist and it's a lot of it is thanks to NUCATS. So I hope we can offer that to many other junior investigators and other research teams.

[00:20:33] Erin Spain, MS: Thank you so much, Dr. Peters and Welty for coming on the show today to talk about all this work that is ahead of you. That sounds so exciting. We can't wait to follow along and see how things progress. So thank you so much for your time today.

[00:20:45] Anju Peters, MD: Thank you.

[00:20:46] Leah Welty, PhD: Of course.

[00:20:47] Erin Spain, MS: Subscribe to Science in Translation wherever you listen to your podcasts. To find out more about NUCATS, check out our website, NUCATS.Northwestern.edu.