So we've heard throughout the conference how important it is that we impact patients. How we get patients medicines they need, how we bring them access to clinical trials. If you take that stake out, hold a group out of the equation, I think the next most impactful relationship you could possibly have to influence that goal of bringing medicines to patients and bringing trials to patients is the site sponsor relationship.
So we're going to focus our panel on solutions to address some of the challenges that get in the way day to day when we're trying to work together as sponsors and sites. Now we've had some very lively panel prep calls, and one of the things I was thinking about as I'm watching the Olympics and Paralympics the last couple of months was how to referee and how to
rain this in a little bit. And one of the things that struck me as a data of a couple of field hockey players and just watching those sports was how in the Olympics and the Paralympics they use cards to communicate, right, whether it's a challenge card or a penalty card or whatnot. So today, and I apologize for all of the innovative technology suppliers are going to get a cringe when we talk about doing this.
We're going to use physical cards.
We've got a stack of green and a stack of red cards, and we're going to challenge our panel today that as we raise a challenge, they take a red card, but that when a challenge is presented, we then have to present solutions to that challenge and we get awarded some green cards. And the goal by the end of this panel will be that we have an overwhelming amount of green cards to show rather than red and pull them up maybe in the final few minutes in a
very analog dashboard of red and green. So with that, and coming off of some of the panels that we heard earlier this morning, we spoke a lot about people and a lot about the next generation. I think it was in Deirdre Bivard's closing comments. I think she spoke a little bit about how we bring in the next generation of professionals.
So I wanted to start with people for our panel.
And maybe we could start with Lisa, maybe you could jump in on this one first, and then we'll probably have everyone way on and this one as such a hot topic. But when we think about the challenge that we're presented with at sites as it pertains to people to acquiring and retaining people. How do you see that challenge and what are some of the solutions that you think are out there that we could put into practice.
To address it.
Thank you, Dennis so Lisa KINI great to meet everybody.
I work for the START Center for Cancer Research, and that is a network of sites, so heavily steeped in the challenge of keeping good people at sites. I've also worked in organizations that are academic health centers that are also doing clinical.
Care combined with the work of research.
And I don't think that any of you are unfamiliar with the fact that research is perpetually unique, right, and we're research and we do it differently, and it requires a different level of leadership and leaders who really understand the challenges of the people who are working at the sites.
And I don't have any quick solutions.
I've got a lot of long, longer term, longer horizon solutions. It really is just give the people a place where they can do research and they're supported in the specific activities that they need to do to do research. So really focus on retention and I think you get a group of people in research that are really passionate about
the science and also the care delivery. That's the people that you have at the sites, and they want to be there, right And I know there's a lot of great jobs in industry and people who are great at that and want to do that will find their way there.
A lot of people who work at the sites.
Want to be there and just want an infrastructure and a leadership team that supports them. And so it requires having the middle management team that really understand what the work of the CRC is and how that's different from the data manager and how that's different from the pharmacy tech and they're getting really specific about what the job
needs to be. We're not good at measuring what their units of service are right and knowing what each job needs to be and reassessing that as the protocol has changed.
The protocols are changing, and so it's just keeping finger on that pulse.
So I'd say great managers role delineation a lot of ways, a focus on retention more so than recruitment, and thinking through career levels and how we can move pharmacy techs up a ladder and how we can move research coordinators up a ladder and also not let the jobs get so big for those patient care facing people that we
forget that they have an impossible job. So like this constant assessment of what's the highest and best use of our licensed team, what's the highest and best use of our research experience team, and calling away all the junk that they don't need to be doing and finding the right role to do that. So splitting the roles very finely, focusing on retention, focusing on career ladders, making sure you have managers who get research and who want to support a team of people that want to do research.
So a very deliberate focus on career path thing and career development, really elevating the role of folks at the site. I think that earns a green card to give out that oh wow stage if I try.
So.
What struck me is that there's also a parallel opportunity for potentially and Eileen, I think if you could explain a little bit perhaps in your role insite partnerships, how as a sponsor we may parallel some of the same solutions that Lisa was kind enough to share.
Sure, so as a as a sponsor, you know, obviously working with the sites, you want to have a nice relationship and you want to really listen to your sites and try to make adjustments where you can to make the burden on the sites less and whatever, you know, way you can do that in terms of having a system with a single sign on if that's something you know that that is something that we hear a lot from sites that there's just so many systems and so
many processes and how can we you know, how you know, can't you make this easy for us? So I think not only CSL Barn, but I think a lot of the pharmaceutical companies are looking to try to take that burden and lessen it for the sites.
Tracy, if I could ask you, yeah, Bearinger, are you creating roles?
Are you taking similar approaches? How are you upscaling your workforce to support sites?
It's actually not necessarily upskilling, but it's reflecting on the points that have been made both from a site perspective and from a sponsor perspective. It's really listening and working together. We've spoken a lot about co creation with patients, but
we're actually also focusing on co creation with sites. So taking the time to get the feedback, really understanding what's important to them and seeing whether or not by implementing certain solutions, we're actually addressing the core like the personal problem that people have with the personal challenge that they have could be as simple as identifying a single point
of contact for support questions. But it's also recognizing that there isn't a one size fits all because the sites are all very unique, their focus is slightly different, their management is slightly different, and so we actually have to look at what's the as far as we can can we actually take it to that level where it is a site specific solution within you know, the broad range of what we can do.
Excellent, So please take a couple of cards and share them with Eileen as well. Chris sites site specific solutions. I see nodding quite a bit as Tracy was describing that, what's your your reaction to that, as as someone who works at a site, someone who has oversight over the research at Sydney Kimmel, how does that resonate with you?
Sure?
Thank you so, Kristin Hermann, Executive director of the Clinical Trials Office at Sydney Kimmel Comprehensive Cancer Center, And I would say you know, I've been to the cancer center at Sidney Kimmel for the last two years, and when I started in the position, we had forty percent turnover annually, and that will crush us, and it will crush your trials. They're not going to get done. And so you know, that was the immediate concern and the fire that we
needed to fight. And within eighteen months we had that turnover down to thirteen percent, and so that's a big difference. But retention is the key indicator right over time, and so we're still looking at that retention.
But some of the.
Things I think that we're really helpful. You had touched on previously about these generational differences, the differences in the folks that we are hiring and recognizing who they are and what their background is and what they care about, and so you know, this youngest generation perhaps doesn't maybe even think that retirement's going to be a reasonable option for them, and so thinking that they're going to want to work overtime for you is maybe, you know, not.
A reality.
While we have some of our staff who've been with us longer and very much you know, maybe that's like our clinicians that are kind of mid career, our managers that are mid career, who really are going to want to be moving up. And so I think taking the consideration who you're hiring and what their interests are, and then customizing the job to a degree and the opportunities to their needs. So whether they're desiring to go back to school and you can kind of highlight those opportunities,
whether they're looking for specific experiences. There will be people who want to go back to school and get an MBA, and then I want to put them on connecting them with our finance folks and our contracts folks. They still may be a data manager, but they can learn a whole lot more about the business internally and then help them to sit in on sponsor meetings, help them sit
down on budget negotiation. And so I think developing people that way and customizing the opportunities to their interests isn't a real opportunity. And so I kind of say, you know, I think that there are additionally opportunities, you know, sponsor and site, especially academic site opportunities that I think we
have yet to explore. This kind of like symbiotic desire to keep our trials staffed and recognizing that there will be people looking to build their careers both in academia but also an industry, and so how can we share better? How can we know that as an academic center, we are primed to educate and train people, but we all do better when we know a little bit more about each other. And so, you know, we did have somebody on our team who started as a coordinator. She ended
up going to industry. She worked as a monitor and she decided that you know, she had experience there that she liked, but she really missed the patient interaction. And she came back and it has been so valuable to us to have her insider industry experience on our team. That's improved the quality of our monitoring visits, our documentation, and so I think that there's also an opportunity for us to explore that further.
So the common theme I think we hear please take a card. I think that's an excellent solution is really creating persons specific approaches right tailoring some of the experience. Chris, I want to bring you into this because I think the thread that I heard through that was the experience at the site, whether that's a sponsor creating that experience, by being more site centric, whether that's the leadership at the site or the site network, providing professional development and
things that create a better employment experience. What are some things from your perspective if you could share a little bit about your role then that you see that might create a more positive work experience at the sites.
Yeah. Sure, So.
I am Chris mcnairm, the director of Data Science also at the Singe Chemical Comprehensive Center, and so in the clinical trial space, my team leads the clinical trial analytics and the reporting groups. But I think one of the things, you know, I think kudos to Christen when when she came in, was how can we take all of these pain points from the staff, right, and you know, automate
some of them, right. Nobody wants to spend their days chasing people down through emails and manually filling out, you know, word documents that they have to chief back through. So it was basically tell us what you are doing repetitively on a day today. And this is kind of between people,
but also between our different disease groups. Why are we reinventing the wheel between all of our different disease groups from study feasibility to startup to all of these different pieces, and so it was really going back to see, you know, what can we create so that people don't have to spend their day doing these manual, repetitive tasks and can
actually spend it doing things that they enjoy. And I think one of the things for us that you know, I don't think this solution has to be the sexiest thing is in the world, as long as it gets the job done. And so we've been able to automate a ton of just the you know, normal day to day operations just using you know, data capture and you know reporting software, and I think that's been kind of a huge relief to the folks that have been involved. And then I think it starts to create this feed
forward loop. I think initially, you know, change is kind of hard for everybody. So even if it's like we're trying to make your life easier by getting you know, these papers out of your hand, it's a little bit of book. Have always used this paper? Why why you're taking this paper away from me? But I think once you kind of change that mindset, then people will come to us more to kind of proactively say, hey, I'm doing this thing. It's kind of a pain point for me.
It seems similar to other processes that we've automated. Can you help us fix this? So I think that's been very helpful and I think also rewarding for the team to kind of see what they've built be used on the day to day.
Well, I have a question for the panel, but I think this is for everyone on the panel. How are those sorts of situations being surfaced back to sponsors? I bet Tracy or Eileen, you'd love to hear where a site has figured out how to do that and share it with every site you work with. But has anyone had that experience? Is anyone having that dialogue within their relationships to share those sorts of things.
I'm going to say for our part, we sometimes hear it a little more randomly. Ad hoc. We systematically get feedback on the challenges, but we are yet to see if, for example, we start to see in the uptick in let's say there is a challenge associated with the use of technology, and we maybe see this consistently coming back from our sites. If we see next time round that this is scoring higher in the trial experience, survice that
we will regularly be sending out we already know. Yes, there's certain things that we would expect maybe to see
based on what we're doing. But I think it's going to be an interesting thing if we not necessarily made any changes, do we then have the mechanism or it's worth us taking it back to say, Okay, we need to put in place the mechanism for following up if we've got this let's say, unprecedented change coming back in the feedback, because it may not be anything that we've done, it may be something that they've done on the site themselves.
So I think it's a feedback loope that we need to systematically put in place to make sure that we're actually recognizing the actions that not just that we're taking, but also that the sites are taking.
I think from my standpoint, it's really tempting to.
Find an automated solution that's going to fix your problem, right because we've got a ton of problems, and it would be so easy to say, if we just had this system, this problem will go away, and times out of ten, in my experience, there's an issue with the with the functional process right where just something that is not sexy at all is broken and you've just got to like roll your sleeves up and resist the urge to find a thingy that'll fix it, and just say,
how are we going to fix the process and kind of do the hard work of getting the functional process ready to go.
Once you really know that.
Your functional process is working, then yes, absolutely automate. But I think you really need from the site standpoint at least to kick tires on is tech really going to fix this?
Or do we have some hard work to do that's.
Going to require change and multiple departments at the table and a little bit of arm wrestling for us to
decide here's how we're going to do it. And in those cases like our drug accountability platform, I think is probably the best one where we were sure, sure sure that we had a solution that would really help us as the site and then we've you know, deployed that at all of our sites and we love it in our pharmacists are all always perfect when it comes to audits and monitors, you know, because we've got a very
fit for purpose solution. But it took us several years of ground lane to go, Okay, now we're ready to put this on a flywheel.
Yeah, I just want to echo those sentiments to about needing to have a standard process across all of your different pieces, right, because I think you made a great point about no amount of technology in the world is going to fix a process that is not standard and is not working already.
Right.
You need a place where you say, here's our process, and here is the exact area where this technology is actually going to help us. Otherwise you're just going to have a different technology for every single different problem that comes up, which is just not going to work for the entirety to site.
Yeah.
So, and I can add to that because Chris and I have worked on specific projects and I'm imagining he's thinking about specifically clinical trial matching platforms, which we've explored and are about. But we recognized after meeting with several vendors that we actually had our own work to do before we were primed to really take advantage of the technology that exists there just in our own process, and that taking on the technology, you know, really that wasn't going to solve our process issue.
We need to solve our process issue first.
And kind of figure out those customized roles and how they're doing the work today and then be able to kind of exploit that knowledge base and primate for the technology.
That's fascinating. I think it makes me wonder and cringe a little bit as a sponsor just when we impose technology on a site hearing that feedback, you know, how well do we know and are we listening to hear what that might.
Do to their processes of their day to day.
Aileen, I don't know if through your work in site partnerships, if you've had those dialogue you mentioned single sign on earlier, are there any solutions maybe to how you've seen this approach, you know, in terms of technology of sites.
In terms of technology, I have had feedback from sites obviously about all of the technology that sponsor imposes upon sites.
And the thing is to continue to listen to the sites and obviously there are certain things that we have to have in place, but there are definitely ways that we can improve how we're deploying them to the sites and what we're requiring of the sites, and sponsors should continue to look for solutions with vendors to make these processes and technologies easier on the sites whenever possible.
Yay, love that comment.
So any tech solutions providers face you know in the audience please take heed to that. One of the things that struck me, h listening to presentation yesterday about a topic that's near and dear to me is it was around vendor qualification and around thinking differently about how we do that and centralizing that I was it struck me as very analogous to when we go out we qualify sites, and we do pssbs and you know, pre study visits.
And all of these things are there areas there If.
I could challenge the panel to think about where there might be opportunities to streamline, whether it includes technology or process changes.
I think definitely. I've had I've heard multiple complaints from sites. You know, we were just working on the study with you, Why do you need to do another qualification visit? I know, you know, one thing is an soop where if we're you know, if we recently worked with the site, then the PSB visit on site can be waived. So that's one of the ways. But I think there are ways for technology to help with ps PSBs and site qualification visits, and I think sponsors should explore them a little more.
We put a lot of thought at start into the study what we would say the study activation process, but I think we think of that as a lot at an earlier point, right, is not just like SIV is the few things leading up to SIV is the study activation process. But as soon as we have interest from a sponsor and a potential protocol, having a fullsome conversation about what systems do you intend to use from your lab vendor, from EDC, any other e things that might
be in the cards, let's talk about that early on. Right, we have to be flexible and as a site, we work with hundreds of sponsors and we need to be able to use.
Their systems and technologies. We get that.
And also if we are clear at the jump about what it's going to take, what those systems are, and we have some back and worth conversation at an earlier stage than I think most of us are used to that, it can really grease the skids for a successful study activation.
And you're not sitting there in the.
SIV with all of these surprises and like bombs going off and gashing them the teeth, you know what's happened where it can just make for like a much more seamless process. So again I don't have any fancy solution but it's really about thinking about all of these things earlier on. I think the presence of all of the new technologies requires us to have a deeper conversation.
At the PSSB.
We call it the discovery call, which is even preempting the pss B to say, what are we really talking about here? In terms of operations, we get the science and our people are connected on the science, but operationally our PK team wants to know what vendor you're going to use to pick up the kits. Do you have that information for us or not? And if not, can you please chase that down so we could clear all
of this now. And that's been really key for us in terms of making it, you know, a seamless integration, in terms of getting that site study activated.
Earlier decision making and earlier communication around those key vendor decisions sounds like a potential solution.
Yeah, And I would say, you know, echoing what Eileen said, if you don't have to send someone to come do the tour of the facility again for the you know, second third or fourth time in the last two years. I mean, you know, the question is like what's the value? So many of the things have not changed, the rooms haven't changed, the equipment hasn't changed, and are you sending someone who's even qualified.
To evaluate what's there.
We're taking detailed, high resolution photographs and providing them, and so just thinking about like that takes time away from a coordinator who could be enrolling a patient. And so you know that time is preparation time, and I just think that there are opportunities to kind of cut the fat on things that aren't essential and to gather the information which is so common across so many of our
different sponsors and CROs that we work with. And so you know, I think you had touched on before, Dennis. You know this potential opportunity to kind of partner with someone who can collect that information and then disperse it and then we're only really answering questions that are really pertinent to a specific trial at hand, and kind of that big picture qualification of our site can really already have been accomplished and not be this kind of repetitive burden.
Our staff turns over, right, we know that, and so when they turn over and this is a new person trying to address the PSSV, it's going to take longer. And so I just think we can make the most of the information that we already have and make it available.
So I think that's a call to action for any tech or other innovators in the crowd. It sounds like there's a solution opportunity there out in the market that would satisfy both sponsors and.
Talk to me.
Yeah, there you go.
Yeah, I was going to say, just to add to that, I think it's a very clear example of where I mean, if I think of it from a sponsor's perspective, sponsors all would like to be the sponsor of choice, right, It's a common it's a common theme, but then we still go out with an approach that reflects us selecting sites. And so how do you switch that mindset around. It's like you tackle that as a common problem, but you know it's a shared probably.
And I've utilized all of Chris's skill set to kind of help us approach that, right. And so when we start looking at activation, we have dashboards and metrics, and we're kind of looking at those and evaluating not just our own performance, but also the sponsors that we work with to say, hey, we want to prioritize this trial because we know we can get this contract and budget done with them and we can start in rolling patients. And so we really are keeping that in mind as
we prioritize the work that we're doing. Who do we know, as you know, when we work with your legal it's going to take a lot longer than most other folks, and so you know, that's really a way for us to kind of streamline things and also put a little pressure on to say, hey, this is kind of taking longer than some other sponsors that we work with, and so what might we be able to do to kind of, you know, break down some of those roadblocks.
Yeah, I think the idea of preferred sponsor, preferred site, I mean, it's it's a great idea and at the end of the day, to me, it just means templatizing a lot of the steps in the process right so that you can manage, my exception, don't have to do
the same thing over and over again. And it can take some time to get that set up at the front end, to make sure that you've got to mutually agreed upon template for name the document that you need to get going right, whether that's the CTA or your budget or your treatsfer agreements or whatever it might be.
But once you've got that setup and you've got that kind of common understanding checked off of like we know how you work, you know how we work, we've got the points of contact, it really can make things.
It just avoids so many headaches.
I think the idea of like the templatizing things to steal your word, I think makes a ton of sense. But I think there's also an opportunity to even standardize and templatize across sponsors, right because you know you mentioned before its sites are working with so many different sponsors.
Like it's great to have you know, some some priority sponsors that you know you work with and work with well, but that only goes so far if you're going to reinvent the wheel over and over again for other sponsors for the same things, for study feasibility, for all of
these other downstream pieces. And so I think there's still an opportunity to kind of close the gap between the different sponsors so that you're decreasing the amount of variability and customization that exist it's across each of those different sponsors. I think one of the issues from a site perspective is that it's really really hard to be proactive and
kind of find you know. I know this is a solutions based off, but it's hard to do that a lot of time when you're constantly being reactive to all of these different things that are being thrown at you all the time. So I think the more you can kind of take away those pieces up front, the more we can focus on, you know, getting a standard process in place so we can find solutions for all these other other issues.
So I can't play guitar for those who are in the keynote, I can't play guitar or do anything like that. But what if, right, what if as sponsors we came together and agreed upon a set of standards and templates for some of these very common things. I think if we could do that as sponsors, I'm sure there's innovative solutions providers out there that would figure out a way to surface that in a really clever way.
So excellent, excellent.
I want to we haven't talked about DCTs, and I feel like you should just talk about DCTs at every one of these conferences. So I wanted to ask, as we have sponsors and sites here, because as a guy who heads clinical outsourcing for a sponsor. I'm constantly in the tug of war of do you do it, which provider do you work with? How do you apply it? And I'm interested as we have a site, so we
have sites perspective, site networks perspective, and sponsor perspective. Is that something that when we look at those enabling capabilities, how do we do that in a way that's patient centric that kind of satisfies all the things we talk about. We're trying to reduce burden, increase access and diversity to a trial, but not due harm to some of our stakeholders at sites, or increase burden or increase the burden of technology and some of the challenges we've spoken about
during this panel. I'm just curious, Tracy, perhaps you'd like to jump in on that one.
So we've obviously had several different variations of decentralized approaches embedded into our carials, and I think so it goes back to what I said initially, we have to we have to actually understand what the impact is on the trail. We don't just do it for the sake of doing it. In some cases there are contractual limitations or oversighte limitations that a site may not want to use the mobile
nurses that we've contracted. You know, it may not make sense and therefore you're limited in the uptake of the remote visits in a particular trial. I think we have to look at it very much again, case by case. Now the approach for us would be certainly, don't make the assumption that don't make the assumption either way the site that the sites don't want to do it or
do want to do it can do it. Are unable to actually talk about what is possible see the extent to which the technology that we use to support it can be embedded with in the technology that's already used on site. The scheduling is an obvious one for me, because if you're scheduling within an app at the same time as scheduling within your regular scheduling system, it's pain.
But also look at is ultimately, if the goal of a decentralized approach is to reach a different patient population, is that even the way that we should be doing it. And yes, in some cases it may extend the reach of the existing sites and it may be something that they want to do. But in other cases, let's accept the population that we've got and then look for other ways to embed DCT approaches to reach that missing part
of the patient population. So I think it's be very flexible and actually understand what the limitations are and you know, what are.
The goals of the site, and have that dialogue. I think I'm interested in that dialogue.
And I think Lisa goes back to what you said about early engagement, about hey, we're thinking about this approach. Does that idea of asking and kind of inquiring what is the existing infrastructure, you know, and how can we leverage it versus impose a new solution?
Thens That's right.
So I think we're in a situation where the technology outpaces the readiness of the site to fully apply that technology and not just apply it, but integrate it. And so I think the question it's not like how good is the tech? The text very very good, the idea behind the tech is very good. The sites would love to see this work, and all they can see.
Are the red cards. Right, are all the reasons right?
You're immediately going to get like fifteen reasons why this is going to be really really hard. And I think that's the interesting conversation is to say, what is it going to take to make this clinic ready and what people would you need to add to.
Your team rate.
So it's like, here's this great tex site, figure it out, and then the sites are trying to figure it out in their spare time on top of the job that they're already doing. So I think having like a real assessment of these are the five to six things that would need to be present at your site, whether that is people, whether that is an org structure setup, whether that's a plug in to somebody who's going to help people troubleshoot.
Whatever it is.
To what degree are these five to six things that we think must be present at your site for this to work?
To what degree can you do that?
And what is a true readiness assessment and how far away are you from readiness?
And what can we help you do to make.
Ready for this Because there's some scaffolding that you've got to build if you're really going to deploy it and have it work.
And right now, the.
Feeling, at least at the sites is like, here you go, we built it, tell us how goes you know exactly?
I think there's also potentially, as I'm kind of hearing
you guys, talk through this. There is also kind of a potential opportunity analogous to you know, right now, there's a lot of focus on like for patient treatment, show me other patients like me that have been treated just like with a certain you know, treatment and responded well due to like having a specific criteria, right, is there an opportunit tunity for the same thing you're talking about meeting kind of both an organizational and kind of technology
stack already at the ready to use some of these different approaches. So is there an ability to kind of, you know, for lack of a better term, been institutions together to say, okay, these are similar functioning institutions with you know, similar technologies and organization structures. It's worked very well for organization X. You guys are very similar, so we think that it's also going to work well for you.
So that again you're not siloing these discussions for each individual site and you're kind of learning as you're going.
In some ways, I actually think that's probably the only pragmatic way. You know, I like to see you can figure it out site by site, but you can't. It's not pragmatic. But rather than just saying okay, here's an approach, see what you can do with it if you can at least start to figure out how it might look in a couple of the setups that you're working with, and then offer that as a It's almost like an add on to here's the protocol that tells you what
you can do remotely on what you can't. At least if you've had that dialogue and you've got some co created approaches that might work, then I think that's a step ahead of where we are today.
Yeah, I think the rapid cycle feedback loop. You know that we had a.
Great experience and at start this was at another organization with a vendor that was doing how managoring, you know, using all kinds of slick stuff and all of these like plug ins and a tablet, and they provided full infrast structure to troubleshooting, you know, is this working or not? And we had the mutual goal of let's fail fast. If it's not going to work, let's try something different.
And we had the right level of project support to really be successful at implementing it, which we ultimately were, despite the skepticism of most of the clinicians involved, because they put the people they really partnered in terms of people and support with us to do it.
That actually just makes me think of we did have an example of where we were looking at a particular monitoring and the question was, you know, if the alarm goes not quite physically, who's answering it? Yes, And they said, well, we don't actually know what we have to do. And I said, okay, you need to talk to the sites
about that because and they did. And actually it was a very positive outcome because as long as they knew, you know, they were quite they were excited about the science, excited about where it would go, and as long as they understood that there wasn't expectation that they had to handle this.
You know, they knew how to respond to the patients, etc.
But it's exactly that it's making sure that that conversation is happening.
So much around communication and around having that dialogue. I think if there's one takeaway, I think that's you know, that's what I'm getting from this panel discussion. We've had a great discussion within the panel around the challenges and some of the solutions. I did want to make the audience aware if there's any questions anyone has, we do have mic set up, so please, you know, feel free to engage, wave your hand or you know, shout at me. There's a bright light in my eyes.
But but but.
Do please, you know, engage with our panel, race questions, race challenges. We won't autograph them. Well, we might autograph them, but you'll get a card if you do. So if any of those pop up, we'll grab them.
We already have a.
Brave volunteer, Marcy Kravit is it on and the can you hear me all right, Rusty Kravit from Anado.
So it's an interesting topic.
And I'm going to SCRs next week as well too, so interesting to hear the site's perspective. But in terms of tracy, you said, you know to talk to every site like you just can't do it right, So who in the sponsor company is doing some of this intelligence gathering? Like what are the challenges going to be?
Okay, now I know it.
So before the study starts, we're already building in sort of mitigation strategies. So the cras right, they don't have the capacity. I'm understanding sponsors now have like site engagement type of teams, But how are the sponsors thinking about this sponsor site engagement at scale to get that rapid feedback about Okay, this is what we're going to have to wrap around the technology to make it successful.
I'll just give you a quick review of what we've done. So actually, when I say we can't get all of that feedback, I don't think that's actually a fair statement. We can probably gather it.
We do have site facing roles.
Those sites facing roles, so we've actually established a site engagement academy specifically focusing on it's more on the soft skills for site facing roles within the organization to really get to know the sites they're working with to understand their challenges. So the conversation you hope happens, it will you know, we'll start to see the update, we'll see
what comes out of that. But then at the same times we have to have we have implemented Global Insights system solution, just a mechanism for sharing insights and so obviously then you hope that the conversations that are happening with the sites make it into their way into the insights system. We have to think about how we communicate it internally so that it gets back to the individuals
that can actually take action on it. And so it's slowly building up that understanding skill set in terms of the empathy building and the mechanisms by which they can share and action the insights that they gather. And then we want to obviously see those actions within any clinical, any protocol and the in the way that we actually approach implementing that at a site. But it's going to
be taking some time. But that's why I say you have to start somewhere in terms of getting some learnings and implementing them.
But a couple of things that we're.
Doing, Yeah, I definitely feel like, you know, sponsors have gotten very good at getting patient advocacy boards in touch with protocol development, and I think we should move along. And I think an idea would be to have like a group of sites who can give feedback as well, you know, is this going to work, what way, what
parts of this protocol can be decentralized? Things like that, And I think having site partnerships or site engagement can relate also help bring the feedback from the site to the sponsor so that they know, you know, what ways we can really help these issues.
I can speak for Jazz and that we have dedicated resources. We've created fairly recently a global Patient Site Engagement.
Group, although they are overwhelmed with the task. I think for a lot of the reasons we've described.
I will say, if there was someone out there developing a solution that could help with integrating those insights from the site perspective, similar to what we do sometimes with some of the solutions I saw the exhibit Hall four with patient input of patient insights, that would be a valued add to the market.
I'd also add, just.
For sites for cancer sites, in particular, the Association of American Cancer Institute's the AACI, we have a list ser we have a conference, the Clinical Research Innovation Conference, once annually, and these types of issues surface there and so we are discussing kind of commonality shared commonalities with troubleshooting, whether it's a vender issue or a sponsor issue, or just
your site's issue. But we are having those conversations there, and so if there's interest in kind of gathering a forum, that may be an opportunity.
I see a gentleman by the microphone and the work. Do you have any preferences or bust case scenarios?
A house sponsors can reimburse you besides paying a lot and immediately, wait, what was the last part of that is besides obviously paying fast and well, I'm not.
Sure if this is specifically reimbursement. I think it ties to reimbursement, but amendments. For example, when we receive an amendment, it can be weeks even months a year. I've seen in cases where we don't have a budget for that amendment. That adds a new cohort and all different visits, and so there's a lot of risk that we face in
doing that. And so we have this challenge of deciding do we take on the risk of maybe we don't even know what the expenses are, but also a billing compliance risk and not knowing what we should be billing a patient versus what will be reimbursed. And so, you know, my one solution there is that if you're going to send an amendment, we very much want to open that cohort.
We really do. We want to.
Enroll patients, and in fact, we have patients primed in many cases to enroll, but we do need to understand how we're going to get paid, and that has been a significant challenge for us.
I would also add.
You know, in some ways acknowledging what you're paying us for it really helps a lot.
From Dennis, So, going back rewriting a bit, I'm the executive director of the Site Council. We've over three thousand side members, including Jefferson help. By the way, you may not be aware and be happy to help find sites personnel to support your engagement operations and.
We won't charge for it.
And if you don't work with I cruinly recommends you don't need the ko well input anymore. You need the workhorse, and you need especially need the coordinators. The coordinators know what's going on totally. They'll tell you the truth, so focus on them, and if anybody wants to pursue anything that.
I'm around, I was actually just going to make a comment to that, because we're we're doing a very large internal systems rollout which we know will impact our sites, and so there is the document exchange element of it.
We love it and when that's good to know. Actually, but when we.
Originally started to look at it from a patient and site engagement perspective, which is the team that I am responsible for, I said that we have to get the coordinators, specifically the coordinators and we now have a panel of coordinators that they basically, I mean, we can't do much about the system, but it is good to get the direct feedback the system to the from the site advisory
panel to the vendor. But what it does do is it makes us more aware of what we should be thinking about when we communicate and roll it out.
Yeah, I think it starts.
We have kind of set up our org chart to be responsive to the way the sponsors org charts are designed, right, and so you've got your site engagement people and we have our sponsor engagement people, and these exact conversations are the ones that are going there to have where we had one sponsor who we were running their entire portfolio of a specific mechanism of action and we simply could not work with the lab interface that they had in place.
And so that's where the intent is that this is a forum where those types of you know, just operational roadblocks are surfacing so that we can be connected into the right person on the sponsor side and say what can we do about this? And again respecting that you've got a lot of sites to work with, we have a lot of sponsors to work with, and so at the.
End of the day, we have to be flexible.
Whatever we're designing on our side has to be able to plug into one hundred different flavors of doing it. But having the forum in place and having the right people on each side of the table to say a right, how are we going to tackle this one has been a strategy that's worked well for us.
Yeah, I see that.
We have one more question, but we're also winding down to the last two minutes of the shop clock, so we'll take that question. We'll try to keep it brief, and then if I could ask each of the panel members following that question to think about one call to action maybe to put out there so it's something we can start doing or stop doing to solution some of the challenges.
Very likely, Please thank you.
I'll be quick. So, first of all, great panel, very interesting discussion. I'm Karina adit sanchio and feasibility something you mentioned, Kristin. I actually started my career as a research coordinator, eventually moved to the sponsor side because of lack of career growth opportunities on the site. How could the sponsor help sites essentially ensure attention with staff by supporting these career
growth opportunities that you're mentioning. Is there anything that the sponsor can do the support?
I think ultimately a lot of that, unfortunately, is kind of internally, right. I think if you don't have a really good leader, obviously it's going to be kind of hard for people to see their value right and you know, see their value at the institution. But also you need a leader that is going to work hard internally to create those steps, which you know personally from an academic institution perspective can be very difficult. So I think just
keeping that communication open. It could be different at different institutions, but I think a lot of that has to be kind of introspectively pushed at an institutional level.
I would also say, maybe we look, we've seen things like clinical fellowships, and is there an opportunity for research support staff type of fellowship with you know, working with a sponsor to kind of gather some information expertise and then coming back. I think that there's an opportunity for that. Likewise, for people who are enrolled in say like our Masters of Clinical Research programs at Jefferson and some fellowships there, and so you know, some collaboration in that way.
I think we had a wonderful conversation. We're down to our last few seconds. I want to thank our panel and please thank you for sharing some solutions from the audience as well.
Thank you everyone, and thank you, thank you, thank you, Dennis, thank you.