 This idol model is a real dilemma for those of you who know me without out a single creative bone in his entire body But well fortunately, we're blessed by having leaders in this organization who are intensely creative So one of the things that I do know is when you have those kind of people get out of their way and don't impede their progress So you're going to get a chance to see these individuals. How do we get the power from that? so What I'm going to do is We've selected three of our greatest achievements over the last funding period the last four years and These are perfect examples of what clay introduced There are things that we started in our building phase But there are three things that are going to be essential for our sustainability and our success in meeting the growing and emerging needs of all of our investigators so The only creative contribution I made to this is the title Just to get you tasted over lunch And for those of you who don't know the clinical research Services aspect of the CTSI is a large group of individuals that provide a number of services for our Investigators including inpatient units outpatient facilities nursing facilities a number of cores Bio-nutrition sample processing body composition and metabolism and a number of other new cores That we're going to talk about today So I'm just going to introduce the three topics and then let the Individuals tell you about them the first is our cost recovery initiative Which is something that's going to be key to our sustainability and is really driven by the Incredible and merging needs of our investigators who are increasing the utilization of our services Exponentially over the last four years it is led by Linda Jacobson Who is our new deputy director of clinical search services who joined us a couple months ago from her position as the director of Administration for the Helen Diller Cancer Center So she's ideally poised to help us with our acceleration and integrate us with some of the other major Organizations on campus that deal with similar issues the second really exciting topic for us Anyway as the research participant recruitment course service led by Narrowman Masser who is formerly from Jeff Bluestone's Immune Tolerance Network Where she was responsible for operational development and implementation of clinical trials So this is a natural collaboration with our emerging Entry into supporting our investigators for clinical trials last but certainly not least is our clinical coordinator course service Which is an example of a faculty-driven service that we have started over the last couple years It's led by Danusia filiposki who is Finished her medical training and then joined us after a many-year history of supporting high-level clinical research here at this Institution so I am going to turn this over to Linda to give you our first idol possibility Linda, please Thank you So very quickly. I'll just share that the goals of the cost recovery initiative It starts with our desire to continue to provide high-quality services To the campus and to the investigators in support of clinical research And actually to go a step beyond that to work to expand and develop new services to work with investigators to understand their emerging needs And how we can be helpful as we go forward a Very basic Goal within this project sounds very simple But it's not and that is to understand the full cost of providing these services services in the CRS include nursing services both inpatient and outpatient and Working in that environment makes it very complicated to understand exactly what the costs of doing business are And in the end we want to optimize the use of our facilities and our resources And why now why are we doing this now after many years of providing these services? There's a lot of pressure on us. There's a lot of pressure on increasing costs The general fiscal complaints that were all constraints that we're all facing and we anticipate They will see some decreases in NIH funding We want to actually begin a change in our culture and to begin to think about as all having a shared investment in these Core services and we want to leverage the funding that's out there and at the end of the day We want to make sure we're managing those resources well So moving forward and we have developed we've drafted and are near finalizing a set of cost recovery principles Those principles were put together by a task force our cast cost recovery task force Which consisted of a number of engaged faculty members and stakeholders who put together a set of principles That will guide us as we go forward in developing policies Those principles say that we're going to grandfather Existing studies and the agreements that we have had in the past for how we will support and fund their services But it proposes that going forward that we're going to ask investigators to invest a minimum of 40% of the cost in the projects that we're helping them to support But at the end of the day the most important part of it is that we have a full commitment to working with Investigators to deal with whatever financial Fiscal constraints that they're facing we know it's important and we are committed to working with people on a case-by-case basis so in my area that we are getting ready to share with the campus the goals and the Strategies that we're looking at in this cost recovery initiative. We're going to continue We have been working with investigators already helping them understand the costs included in their proposals for our services Yay, what I do Just anywhere there we go and We're working right now with people on Estimated rates for the services and we're going to move forward and develop and publish Formal rates that will be available to people on the web and that we that people can look at and understand what it will cost to use the services But very important to me is that we're also going to refine what we're doing internally so that we're sure that when we're doing all For this we're doing it on a timely basis and meeting all of your needs So look forward to working with many of you as we go forward Thanks very much So I'm going to talk to you briefly about the participant recruitment services, which are coming online very soon probably in the next four to eight weeks one way I'm going to really boil it down to three things supporting increasing and improving recruitment for all of the investigators here at UCSF and With the affiliates first. We're going to support the recruitment activities. We've made a commitment and have Already kept to that commitment with our staff to date who are all Trained and very well-versed in clinical research operations and each of them brings a unique skill set along with that that pertains to some specific aspect of recruiting participants into clinical clinical studies as part of our service We're going to be providing a full consultation and recruitment analysis of the landscape for your study and then also providing a plan that can be implemented in a very Staged approach and will also come with a budget and timeline so that folks can understand the best way to recruit their study Over a specific period of time Secondly, we're going to increase the participant pool. This is really what it's all about We need more potential participants to get into all of these studies that we're recruiting for We're going to do that in two very distinct ways one is that we have developed a Research participant registry, which is for the public to come in and volunteer providing a brief health history and There are consent to be contacted for future research that will become a pool from which we can recruit participants for any study And secondly, we can make more efficient by centralizing the method Which we use to recruit folks out of the integrated data repository, which is the research Repository from which we derive Fields from the electronic medical record for recruitment purposes And lastly, we're going to improve the efficiency of recruitment efforts by centralizing these efforts with us Not only are you gaining our expertise? but investigators are also able to take advantage of the fact that we can leverage a lot of vendor opportunities and we can also take advantage of Economies of scale in terms of recruiting across campus and across the medical center. Thanks Want to talk to you briefly about the clinical research coordinator services that have been part of our new initiative Little bit about our origins. We are a new CT site service that was inspired completely by investigators needs and requests it was initially piloted for about a year by doctors war a puck and Milosevic and we had one coordinator and That coordinator was in charge of about four studies across those three departments It was so successful that luckily I got a job in August of 2010 And was asked to create an official CTSI service In the ten months that I've been on board we've grown to a staff of five people and I'm currently still hiring one more and All of our coordinators are supported 80 percent by recharge from the PIs and 20 percent by the CTSI itself Little bit about our development our coordinator services. Basically, we provide any service that an experienced coordinator can do We work with all UCSF PIs all departments and all specialties all locations where UCSF PIs conduct research And pretty much everything else obviously within reason We're starting an education initiative creating a curriculum for anybody who works in clinical research It's starting out with brown bags and Small workshops and eventually we hope to have a certification program whether we create our own or adopt one that already exists Is still to be decided and I'm also working sort of as a switchboard for coordinator services Which means that if somebody is looking for coordinator, we can't provide them I will know possibly about coordinators that have some time and we can put them together To make things work quickly our induction. We've done 45 We've had 45 requests for service in the last year. We have supported 32 studies five of which are early career investigators These are the lists of all the sites that we're currently Supporting which includes satellite sites outside of the regular UCSF system like our RAI dialysis center at Hay and Caesar Chavez and then a quick list of our specialties Oh, I'm about to be kicked off the stage one third pediatric two-thirds adults and a long list of subspecialties that you can see there Thank you Great work CRS, so Virtual rock opera of achievements Sam you want to start us out First of all, I'd like to congratulate Linda and make a consultation appointment Because you basically described a new recharge tax and got applauded for it I've tried several times In the last three years to do that and I've been booed off the stage on the education So so congratulations on that On the coordinator pool, I think it's a fantastic idea When I think back to my time as a chair in pediatrics, I I tried over and over again To get people to to share coordinators, but everyone Kept coming back to me to say no, we have to have our own They only understand what we're doing and I was just wondering how how you got over that Barrier of people feeling like they each had to own their own and make a pool successful I think the we had an unlikely ally in Making that happen, and I think it's just the fiscal reality we live in The very fact that finances are so constrained means that people are more cooperative certainly in California Maybe not in Washington, but certain certainly here and I think that's really been the difference So if you can get a study our study coordinator for one need that comes Finishes the need and then leaves you don't have an FTE You don't have all the other things that you have to do with a full-time coordinator I think that's really one of the major drivers. Would you agree and all those startup costs, too? You know the post-in-a-job job description Interviewing all those candidate reviewing all the CVs all that's gone, too And then we absorb the vacations and all the other sorts of things. So it really is a very scientific and fiscally Responsible thing for investigators to do. Are we attempting to quantify the shift? I mean how many coordinators we had employed For X number of studies before this initiative and after to see what true economies we can achieve We're starting to keep some of that data. We don't have very much yet at this point Still early, you know, we've not enough people to really make a huge impact on campus yet But it could be a great model for the future. Tal much add a corollary of Sam's question about costs So one of the things that's pretty common here is that a lot of the things that actually cost us money are buried in other things So when you try to pull it out and shine a light on it and say you have to pay for it It collapses the the system and so what I'm what I'm I'm curious how we're gonna when you when you pull this out how we're gonna overcome that underlying Pressure that that this was actually a cost it was buried in in our system and and there was no money for it Really, but there is real money. There's real costs in it and the other part of that question I'm sorry for the two-part question is and I think you answer this you are actually the deep part And how are you paying for it? so Okay, so let me I try to answer the second question first Deep pockets in the sense that we do have the luxury and the privilege of having NIH support So that is the money that we're using to grandfather in the studies that have already existed So we don't have to you know change any agreements that have been made and it also allows us There the resources to support the career development of early career investigators who don't have The grant wherewithal to run any of these kinds of studies I think as time goes by and we can anticipate that some of that support will decline That's why the recharge will give us added resources to Provide support to our investigators the other advantage that we can use those deep pockets for And this came out of our faculty driven task force is that we can now provide a safety net for our investigators who may experience a Arbitrary cut across the board of the budget of their grant So if you have an R01 for instance with four specific games and it has a wonderful scientific score And that goes to council and loses 25% of its budget You're in a catch 22 because at the when you go for your competitive renewal You have to show progress on all four aims yet. You only have the budget for three We can underwrite that and that's I think one of the things that we wanted to come up with to help the Investigator community embrace this so I think this was a very clever thing that this Task force came up with that we've embedded into our principles that hopefully will help us Help us move this forward Your other question is Absolutely on target the hidden costs I don't know that there's a single place that I've ever worked that really understood the costs of doing anything let alone Clinical research in an academic medical center. We've spent the last year trying to pull back the the layers of the onion We have a costing tool that I think does a pretty good job But it doesn't hit everything so I think that's gonna be something that we're gonna have to work with the chairs And the divisions as we go forward to make sure that we're being accurate to not overcharging But also not undercharging as well, so I get so there's one thank you But there's one other question that I wonder how are you gonna solve it? Maybe somewhere later in the presentation. They'll be answered but underrepresented minority participants on Clinical trials is a problem everywhere. Yes, and I think it's a significant problem huge problem And so I wonder are there special things being done to try to Nairman do you want to yes? I think there I'm gonna let Nairman feel that that's an extremely important question And this is something that comes up every day. I think One thing that we're trying to do is of course this research participant registry But along with that not just putting it out there and hoping that they will come But actually when we go to promote the registry in the public going into the community having materials available in their language I have two people on my staff who are Spanish-speaking and actually do Spanish translation. So even in our pilot work We're already making sure that we're including not only Spanish translation, but potentially Cantonese translation So we're already thinking about that before we even begin and making sure that we even engage Investigators who haven't thought about it when they come to us and make that available to them and the experts that exist on camera You have a major advantage that we haven't had and that is if you have a stable of coordinators who are consistent One of the things you could present to the minority community is that consistency because that's what they really hate is that the people come and go So if you train your coordinators so that they understand diversity They're comfortable with it and they then appear in the minority community at events and things like that it'll change I think overnight And we have some successes in that already with our clinical research unit and presence in the tenderloin where we are touching some extremely underserved populations in that neighborhood and that's been a model that Neriman and Denousha have been working through and with Great. Good David. Well, I agree here a lot with Randy and Paula He volunteered to be Paula And now we know who Simon is So as a grandfather, how do I get grandfather's dad? No, no, I'm kidding There's got to be some link here across the different cores and just the last question that we're dealing with Interactions with the community core to build that kind of relationship For having recruitment Is that a question a question? No, no, that's fine for this group. Yeah, do you remember you want to? You were talking about the community the community core the community engagement program yeah, so You know, we haven't started our operations, but certainly I've been in close contact with it with the community engagement program and they are definitely on the forefront of working together with us when we get ready to Send out the message in the study specific way But one thing that my group is already doing in terms of working with the community directly is we're helping to sponsor a National event in November called aware for all which is managed by a non-profit that provides education for research Participation and I think that that's one way we can start putting ourselves out there as an institution that wants to work with The community and that particular event is focused on minority Population so great. All right. It's great harmony here. Yeah, one other one other thing to Leverage off of your last question is that Even though we're presenting this in terms of our specific areas of responsibility. I think it's very important that It comes out that we are all working together So the all of the clinical research course not only the three here But the others that I mentioned are working very closely with community engagement Because we are really providing those investigators and the collaborations they make outside of our system We're giving them the tools so that they can be much more effective And I think that's one of the wonderful advantages that this organization can provide that if we were doing this separately We wouldn't be able to provide