SCRS Talks
SCRS Talks, hosted by the Society for Clinical Research Sites (SCRS), is a platform for clinical research industry professionals to hear about valuable information shaping the research industry today. These short interviews will provide new perspectives and insights on pressing topics, current events, and the research community.
SCRS Talks
Breaking Down Silos: Moving Study Startups From Isolation To Integration
In this episode, Dr. Christine Senn, Senior Vice President of Site/Sponsor Innovation at Advarra, explores the challenges of study startup and the risks posed by working in isolation. She emphasizes the power of moving from siloed processes to integrated collaborations between sponsors, CROs, and sites. Through real-world examples, Dr. Senn demonstrates how this collaborative approach is driving results in healthcare — accelerating timelines, reducing costs, and ultimately improving patient access to clinical trials.
Welcome to SCRS Talks presented by the Society for Clinical Research Sites. Thanks for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. Today, I'm joined by Christine Senn, the Senior Vice President of Site/Sponsor Innovation with Advarra. We're here to talk a little bit about study startup and some of the steps, innovations, challenges and solutions that have come to light recently and how we might improve some of that process. Christine, it's great to have you. Really excited to talk about this topic specifically because it is always such a hot topic amongst the sites. But before we jump into the questions, I'd love to learn a little bit more about you and Advarra.
Christine Senn:Yeah, it's quite the hot topic. I'm very excited. I started at an academic medical center at University of Vermont. That's when I first got really interested in study startup as well, seeing it there, and then I spent the next 16 years building a site network that became Centricity Research. So my role is to bring sites and sponsors and CROs together with the idea of like overhauling these relationships, these partnerships and collaborations to improve our industry. And I know that sounds high in the sky, but Advarra is in a very unique position of having clients throughout the clinical trial ecosystem, sponsors, CROs, academic medical centers, cancer centers, independent sites. So I think we're in a really good position to bring people together and try to get this topic among others discussed.
Jimmy Bechtel:That's excellent. I'm excited as well, Christine. So thank you. We know study startup is really critical to the success of the trial. It's that first impression. It really sets us up for success and gets us a good sense of where we're at from a timeline perspective and how kind of the rest of the study is going to go at a particular site. But in order to improve collaboration in that area. Moving from this concept of one off or isolation siloed approach to an integrated approach we know is really critical and key to doing that. So could you elaborate and talk a little bit about what that looks like, that move from isolation to integration in practice and how we can use it as an impetus to transform that startup process.
Christine Senn:Yes. And I think you would agree, it's not for lack of trying that this is happening. I think every organization is a little more siloed than they want to be individually and everyone is trying so hard to bring us all together and it just isn't working for various reasons. And that's where I think we need to have more conversations like this. So from any company, but I'll just start with sponsors and CROs, I think of it as a three part process. It would be starting at the internal. So you need internal processes at your company that flow. So at your organization, you're getting rid of silos. No matter what size company you're in, you're always going to have some level of silos and you always have the ability to integrate more and more and more. And it's an ongoing process improvement. I recognize how hard that will be. But anything that can be done internally is going to have a huge effect on the business itself. So I would say that once you're done as much as possible, improving from within, or you keep doing this process, then you could collaborate with each other to ensure the processes are refined to work for another. So what I mean by that is if a sponsor is trying to get rid of internal silos and is coming up with processes, then maybe they have a couple, three CROs that they are working with most often. Well, now get them involved in the process. Where does this process need to be tweaked? How could we improve it? What are we not thinking of because we didn't include your process? And then really you're now expanding this to be more collaborative as well. Then finally, I do think at some point you have to bring in thought leaders from various types of sites. There are many wonderful site leaders. We can talk to them and say, you know, how does this fit in with your process? Oh, that doesn't work because you never know when you're going to find out that it doesn't work for a site. And of course, there'll be one offs. And, you know, one type of site, perhaps a very large health system is going to work differently than some of the smaller independent sites, but that's important to know you could end up having modified processes, depending on something, whether they have an internal review board or whatever else for the sites. I think it's the same thing, right? I mean, I apply this to everything fix your internal silos. Every department should be talking to each other. But beyond that, is that willingness to adapt and and do what's right for the greater good. And the reason I say that is because I think sometimes people will look at processes and not really recognize that the process within the finance department, contract and budget, whatever it is, that sounds like it's just a departmental problem or process, however you want to put it, is actually hurting the patient in the long run and is hurting our entire ecosystem of how much things cost. So the greater good is the fast startup decreases trial costs and decreasing trial costs decreases the cost of medicines and devices if they're approved, and I think that's a really important thing to remember is we're trying to make health care accessible for all.
Jimmy Bechtel:Excellent points, Christine. And what I took away from your wonderful explanation on some really processes and things like that is that it is step wise, right? There are there are steps that you need to take to be able to do this. It's not just a complete shift and it's iterative, right? We're taking these steps and we're improving things piecewise and slowly as we chip away at these siloed approaches to make things improved. And I guess the point is you're not going to go from silo to fully integrated overnight, right? It's not just going to happen and everything's not going to work. It's, it's this slow sometimes but intentional and again, iterative process to improve anything from a process improvement standpoint, but specifically in the case of startup kind of looking at those areas specifically.
Christine Senn:A hundred percent. And I would say that that is also cultural, which development culture within your department, your company, whatever, like I would say when I was the COO of a site network, it was, I know we just redid this whole process. I don't care. You come to me tomorrow. If you get new best practices, we're just going to update it every day. If that's how often we get a new idea. And I think that's a wonderful way to improve.
Jimmy Bechtel:Excellent. Yeah. I agree completely with that. I want to talk about site feasibility being that crucial first step when a study starts. Again, we're talking first impressions here. So what strategies have you seen or experience or maybe even implemented that have proven effective in improving the feasibility portion of startup?
Christine Senn:This one will be a shorter answer. I think just the fewer questions asked the better. This would be especially true I think if a sponsor CRO has worked with a site before. They should have a relationship and know some certain basic things about the site, but really just in general, ask fewer questions and only ask questions that are pertinent to trial enrollment. I think a lot of people listening will know that if you work at a site, and you asked me if I have refrigerated centrifuge, and I don't, I can get one by the end of the week. It's really not like the fact that I don't have something doesn't mean I can't get it. There could be some exceptions with very unique testing, like there was PBMC testing. I can't remember what that stands for, but with the COVID trials, and we're always trying to find PBMC testing that was within a reasonable distance away, for example. There could be some special things, but it should be a really, really special thing to be asked about, and everything else should be, do you truly, truly have this patient population and can enroll these patients.
Jimmy Bechtel:And Christine, have you seen some success in this space? Like, are there organizations that are starting to do this? Because, you know, like you've said, and I'm sure a lot of the sites listening on the line are probably nodding their heads to this. You know, you kind of get that same feasibility questionnaire every single time, regardless of how many times you've worked with said organization. So have you seen, again, speaking to this concept of iterative processes here, have you seen organizations that have started to do this and kind of, think critically about feasibility and say, Oh, we've worked with this company before. We know a lot of the answers to this question. So we're maybe, you know, ask them, Hey, has anything changed based on these answers? Plus here are the answers specific to this study that we need you to ask. Maybe just as an example.
Christine Senn:Yes, I have. I have to say it's not broadly applied. I think if I gave the example of the company I've seen it happen with, it would be too obvious who it was, but there is a sponsor company that does it pretty well. And I'd say that what I see in general is the best way to do it. stronger their efforts at relationships with the sites, the better. But of course that onus is also on the sites to keep up those relationships, right? If you have a lot of turnover, that is a problem as well. But yes, people, there are definitely sponsors who are going to, we do not need to recollect this every single time.
Jimmy Bechtel:Great. Well, and the point of that question, right, is to kind of, you know, kick the ball over the fence a little bit to some of those other sponsors, we don't need to name names, but some of the other sponsors that maybe aren't doing this very well to say, Hey, this is being done. Your competitors are doing this, so it's doable. So let's all get on the train here and make these small changes to improve our startup process. So continuing to move through here, then once a site's been selected, what are some of the ways that sponsors, CROs, and these sites work together that you've observed or or maybe that you want to highlight more effectively to streamline the contract and budgeting process? Because we know again, major sticking point here with study startup. And we've heard from patients like TJ Sharp, most specifically around the negative ramifications that delays in this process can have on patients that are waiting for these treatments and waiting for these clinical trials.
Christine Senn:Oh, that is heartbreaking. There are more and more examples that are coming out. Maybe patients are getting their voice or a place to have their voice to show like. I could be in that trial if that had just started up. That is just heartbreaking. Contract and budgeting is actually interesting timing that you're asking this because I spent the past couple of weeks talking to sites about a particular sponsor issue. There are some really, really delightful efforts by some sponsors of trying to pay for as much as possible in a clinical trial. And one of the things that they've been seeing and they came to us about was Well, why are some sites saying, no, we can't just pay outright for all of these items. And they were surprised, right? Because they're trying to pay for as much as possible. Really have to say thank you to those sponsors. It turns out that there are some issues in regard to health insurance billing. Now I am going to talk only from U.S. here, cause I'm trying to give an example and I don't know other countries as well, but it's that when you go to bill for insurance, as an example, you can't bill for the second infusion if you haven't billed for the first infusion. Or if you have to get infusion because there's some side effect happening, like, you know, the person's getting nauseated or something. You can't do that because there's no proof that you did any other infusion. And so I would say that one thing that I did not even think about until a couple of weeks ago, after doing all these interviews was that sponsors and CROs could really learn on the U.S. side, how billing works from the site side, what that looks like when you're at a healthcare system or a cancer center and have to bill for these. I think there's a huge discrepancy in knowledge there.
Jimmy Bechtel:Yeah, I couldn't agree more. It's tough to solve for that, right? It's a lot of education, a lot of learning, a lot of engagement, and kind of the theme of our discussion here, it's a two way street, right? It's a lot of this interaction and relationship building to help find where some of these gaps are so we can address them.
Christine Senn:Yeah, and to your point about relationship building, I guess that would be the other point we would all make, which is get on a phone call if you have a question. I had a site leader to reach out to me and say, you know, this contract and budget process was taking so long. It was like, 8 weeks in and, and nothing had happened with negotiating this contract and budget once the site sent back their comments. And his question to me was, why is this happening? They told me that they are working. They're waiting to batch all of their questions at the CRO to send them to the sponsor. So, by batching them, they're making all of the processes for all of those sites take longer. So that's not a great process at all, which I don't think was my point about getting on a call, but get on a call and find out why ask a question. Don't batch them all. There are a few things we could do.
Jimmy Bechtel:Yeah, I agree that is an interesting approach. I mean, props for trying to come up with a different way to do things. But you know, it's again, this idea of these iterative processes and kind of going back to the drawing board, okay. And saying, oh, we tried this and it doesn't work. So let's try something else. I think it's the important modality there. Well Christine, last question here that I wanted to address with our time together. It's been great to have you lots of insights, I think here, but how can improved collaboration than just in general solve, improve the trial's patients experience and the recruitment process?
Christine Senn:Well, it, in my opinion, a patient recruitment isn't a collaboration problem so much as a branding problem. What I see is that sites are entirely capable of recruiting. They might need sponsor funds added. That's fine. But I think sites are very capable of recruiting, but that there's a general public fear of clinical research, and we have seen in our recent history that when clinical research has a good name, more people enroll. So my thought on patient recruitment is I would love to see sponsors and CROs use lobby money to work toward a global campaign where we're changing people's perceptions of our industry. And I think that's the real bang for our buck.
Jimmy Bechtel:Absolutely. I think it's definitely a great piece of the puzzle that we can solve, right? Part of how we can fix what we're doing here. And we won't have time today to get into this concept of awareness and trust and everything like that, that kind of goes along with that work associated with what you had just mentioned. But it is definitely all part of this big challenge that we're solving with improving recruitment and getting these patients into and trustful of clinical trials.
Christine Senn:There is an initiative, though, that I think would be worth talking about because it could be replicated. I just learned about it within the past year. I think it just came about. But Novartis has an initiative called Beacon of Hope, and it's a partnership where they started, but it has other sponsor companies and some other companies as well, like tech companies, for example, Advarra provides the CTMS, sponsors are providing trials and funding, but it is for Historically Black Colleges and Universities to start doing clinical research and to really put that into the universities. And I think that's really great because now you're getting to teaching hospitals, you're getting to places where patients are that perhaps we haven't reached before. I think it's a beautiful initiative, and that is truly collaborative Novartis startup, but it's truly collaborative. Lots of sponsor companies have put into that seeing a need for that.
Jimmy Bechtel:It's a great initiative. We have been involved in some of those discussions, and they've been bringing that to life with some of our work in diversity, equity, inclusion and all that. So, yes, it's a great impetus for change and moving things in the right direction for a very necessary population for sure. Well, Christine, thank you so much for your time. Thank you for sharing your insights and talking a little bit about some of the challenges that we see with study startup and how we can maybe think outside of the box, I guess a little bit. I know that's kind of a cliche term, but looking at these processes and coming together, collaborating on how we can solve them because that truly is some of the ways that we can do this. And we know that it's happening. Because there are, as you had mentioned, you cited some examples, change is happening. And we know some of these things are improving. I just wish that it would happen a little bit faster. But here we are and we can only move as fast as we can. But thank you again for sharing your insights and being with us today.
Christine Senn:Oh, you're so welcome. I love how forward facing and practical and solution oriented SCRS is. So I love everything you all are doing.
Jimmy Bechtel:Well, thank you very much. And for those that are listening, as we conclude, don't forget to also explore other site focused resources made available to you, like the various publications and webinar opportunities on our website, myscrs. org. You'll also find a wealth of content and details about our upcoming engagement opportunities, like our Site Solution Summits being held throughout the calendar year. Thanks again for listening and tuning in and until next time.