Yale Psychiatry Grand Rounds: November 10, 2023

November 10, 2023

Information

"Yale Center for Clinical Investigation: An Update"

Speaker: David Coleman, MD, Interim Director, Yale Center for Clinical Investigation; Emeritus Professor, Yale School of Medicine

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00:00It's a it's
00:03a pleasure to join with you this morning
00:06and and talk to you about the Yale
00:09Center for Clinical Investigation.
00:11I'm thrilled to be back as a member of
00:14the Yale community and particularly
00:18eager to engage with you this morning
00:22to learn more about how YCCI can
00:26be more helpful to those of you
00:30engaged in clinical research related
00:33to patients with psychiatric and
00:36other behavioral health disorders.
00:39So I will devote,
00:42I hope a significant part of this
00:47presentation to what I hope will
00:49be open discussion of where our
00:54opportunities and challenges are.
00:57So let me try to share my screen.
01:06Hopefully that is visible.
01:10There we go. Perfect. OK.
01:12Are you seeing the full screen or
01:14are you seeing the just your slide,
01:16just your slide? Oh, OK, good.
01:20Let me just reverse that now.
01:24We're good. OK. Nope.
01:26Back to the way it was.
01:27Oh, it was the right way.
01:31All right. There you go.
01:34It's reversed for me. OK.
01:36So what I hope to cover today is
01:39to give you a little bit of an
01:42overview both of our mission and the
01:45history of the center to describe
01:48the administrative organization,
01:50which is changing very substantially.
01:54To describe the services
01:55that we offer briefly.
01:57And then to have a conversation about
02:01where our our challenges lie and where
02:05our opportunities are and how we're
02:08trying to meet those opportunities
02:10with an array of new initiatives.
02:12And then a brief summary I have posed
02:16as a question that I'd I would very
02:20much like to discuss with you That
02:23is how the opportunities specifically
02:25in research for psychiatry could
02:28be more effectively served by our
02:31center and I and I hope to learn from
02:34you in that regard this morning.
02:36So the mission of of Yale Center
02:39for Clinical Investigation
02:41is to facilitate the the,
02:44the conduct and the training of members
02:48of the Yale community in impactful,
02:51safe,
02:52efficient and effective research
02:54on human subjects.
02:56Our our training programs are
02:59critically important part of our
03:02mission funded jointly by the CTSA
03:05award and by the School of Medicine.
03:09We're also charged with supporting the
03:11development of new methods of clinical
03:14research to improve health outcomes,
03:17an area that has taken on added
03:20significance given the emphasis of
03:22N cats in translational science.
03:25And then lastly and importantly,
03:29our mission is to enhance the
03:31dissemination and implementation
03:32of research findings to make them
03:35available for all patient populations.
03:40YCCI is part of a larger clinical research
03:44infrastructure at the School of Medicine.
03:47We are a university wide center,
03:52so we specifically are charged with
03:56serving faculty throughout Yale University
03:58and particularly those on the medical
04:01campus from the schools of Nursing,
04:04Public Health and Medicine.
04:07We also house Administratively House
04:10and and run the Clinical Translational
04:13Science Award and several other large
04:18grants from external agencies devoted
04:22to clinical research methodology.
04:26Sister center,
04:27the Yale Cancer Center has a large
04:30portfolio of services as well
04:33and is similar in many respects
04:36in its mission except that it's
04:40exclusively focused on cancer.
04:42And then there are a variety of
04:45departmentally based units in
04:47in several large sections and
04:49departments such as cardiology,
04:51neurology, geriatric psychiatry,
04:53anesthesia and medicine.
04:55And these have evolved over time to
04:59meet some of the unique challenges
05:03that faculty and their respective
05:06content areas or geography or
05:09scientific questions really require.
05:14So it's important to just take note
05:17that we are an important but not
05:19sole provider of clinical research
05:21infrastructure at the Yale School
05:24of Medicine.
05:27So over the course of YCCIS history,
05:31which began back in 2005,
05:35the center was the primary
05:41impetus behind this successful
05:43application for the first cohort
05:46of Clinical Translational Science
05:49Awards funded by NIH in 2006.
05:53The Yale's CTSA has been
05:56continuously funded since that time,
05:58a really remarkable achievement.
06:02The trainees in the so-called Yale
06:05Scholars Program of YCCI have involved
06:08the training of 200 faculty from 24
06:12departments with a substantial record.
06:15Over the years in grant
06:18funding and publications,
06:21YCCI developed 36 new programs,
06:2711 portion of which was one of the
06:30first bidirectional interfaces
06:32between EPIC and the clinical
06:35trial management software ENCORE.
06:40YCCI and the Cancer Center are major
06:43sources of support for what has been
06:45a really substantial increase in the
06:48number of industry funded trials
06:52as well as those funded
06:56by NIH when YCCI began.
07:01Approximately 1/4 of the RO ones
07:05through Yale School of Medicine
07:07had a human subjects protocol,
07:10and more recently that number is up over 3/4,
07:14which reflects a combination of
07:16changing priorities of funding agencies,
07:19but also importantly,
07:21the interests and infrastructure
07:24of the Yale faculty.
07:28The YCCI developed a number of interesting
07:32community engagement strategies to help
07:35us discover program and Yale Cultural
07:39Ambassadors Program have been models
07:42nationally for community engagement
07:44of research and in particular for
07:47extending research to relatively
07:51understudied patient populations.
07:55We've provided a lot of services over
07:597000 and those those services have
08:05given rise to nearly 5000 publications.
08:08There's also been a very substantial
08:11number of pilot grants and RFA for which
08:14is about to be distributed once again.
08:17So there is much to be proud of at
08:21Yale in its history of clinical
08:25investigation and YCCI has had an
08:27important role in that history.
08:32The numbers of clinical research at
08:35the School of Medicine reflect the
08:38generalizations on the previous slide.
08:40If you tabulate just the number of
08:43clinical research protocols that
08:45are not exempt from IRB approval,
08:49that is studies that need IRB approval,
08:53it's roughly doubled since from
08:572019 to 2023 from a little over
09:012000 to a little over 4000.
09:04It is important to note that in
09:06all of the categories there's been
09:09substantial increases but the the most
09:12dramatic increase as I alluded to
09:15earlier has been industry supported
09:17trials going up nearly threefold in
09:20the five year period since 2019.
09:25It's also notable that we support a
09:30number of unfunded studies at the
09:33School of Medicine and the we here
09:36is departments and the Cancer Center
09:39and the School of Medicine and YCCI.
09:43And these unfunded studies are as
09:47you would imagine a mix of of studies
09:50that primarily are focused at
09:54generating preliminary data for
09:56eventual grant submissions.
09:59So really I think a a impressive
10:03and good news story for growth of
10:07clinical research at the school
10:10and this obviously reflects the
10:12commitment of the leadership of the
10:15school going back several Deans.
10:17But a lot of this growth occurred obviously
10:22under Dean Alpern and now under Dean Brown.
10:28An important perspective is on how YCCI is
10:34supported and I think there's a there's
10:37a couple of really important messages
10:39here that I want to leave you with #1.
10:42If you just look at the blue
10:45part of this pie chart,
10:48we are on schedule to receive
10:51just under $25 million from the
10:55combination of the School of Medicine,
10:56the Faculty Practice Plan or Yale Medicine
10:59and Yale New Haven Health System.
11:03So this represents A remarkable
11:06contribution in my mind of those 3
11:10entities in support of clinical research.
11:14It's also noteworthy that we get just
11:18under 9,000,000 and the orange slice
11:21from our our CTSA in contrast to many
11:27other academic medical centers are
11:32YCCI infrastructure is relatively
11:35well supported by the institution
11:39that in our survey that we've done the
11:42ratio between institutional support
11:44and CTSA range from 1:00 to 1:00
11:48to to 3:00 to 1:00 and we are in in
11:52roughly in the three to one ratio.
11:55So I I think it is important to to
11:57celebrate really and certainly to
12:00acknowledge the fact that the health
12:02system and the School of Medicine as
12:05well as the the clinical departments
12:08are really making a substantial
12:11contribution to this center and to
12:14the growth of clinical research.
12:17The the Gray shaded area is
12:21reflects our projected revenue
12:23from services that YCCI provides.
12:26Most of that revenue comes
12:28from research sponsors,
12:30NIH and industry and we're projecting
12:33A substantial increase in that revenue
12:36as the number of projects grow,
12:39our services expand and we increase
12:42the rates for those services.
12:45And then there are in addition,
12:47there are grants from Pharma
12:51Foundation and from FDA that
12:53provide additional revenue that
12:56are managed through the center.
13:00Our training programs are are listed here.
13:03I know there are a number of
13:06faculty from the Department of
13:08Psychiatry who have participated
13:10in both the T and the K programs.
13:13These are both of these programs are
13:17funded about 60% by the CTSA award and
13:22about 40% by the School of Medicine.
13:27We also offer a number of other services
13:31for trainees and faculty in grant writing,
13:35a summer Rokats program focused on developing
13:40skills in interdisciplinary team science,
13:43several both individual and group
13:47meetings to discuss research.
13:49We also try to facilitate and select
13:53candidates for supplementary awards,
13:55particularly diversity supplements.
13:56And we do house at least part of the support
14:02for the Investigative Medicine Program,
14:04which as you probably know is the
14:07MD to PhD program that is offered
14:11by the Graduate School.
14:15Our services that we offer are listed here.
14:18These are in various states of
14:21expansion and in some cases contraction.
14:26When we ask faculty where
14:28we can improve the most,
14:30what we hear is on the first line
14:32Biostatistics and study design.
14:35There is a tremendous interest in
14:38expanding these services so that faculty
14:42have greater access to those services.
14:47But in addition, these services,
14:49I won't read them all to you,
14:51but just to convey the,
14:54the sense that there's a very broad range of
14:58services related to the conceptualization,
15:01activation, execution and then completion
15:06of clinical research protocols.
15:09The one area that we are contracting is in,
15:13well maybe there's two areas.
15:16One is in sample management.
15:18We are we have been one of the several homes
15:23of bio repository mostly a blood samples.
15:28We are continuing to store those
15:30but we are beginning to advise
15:33investigators to use the central
15:37repository in pathology and lab medicine.
15:42We are also getting largely out
15:46of the data management business.
15:48We will do some.
15:49We will be the business owner of
15:52several data management platforms,
15:54but the new section of biomedical
15:58informatics and data science is taking
16:01over these functions and bringing
16:04frankly tremendous expertise to this area,
16:08which has been historically pretty
16:11widely distributed in several
16:13different centers including YCCI.
16:15So this is largely being excised out
16:18of YCCI and migrating administratively
16:21under this new section directed by
16:25Doctor Lucilla Onomachado and we're
16:28very excited about that partnership.
16:35So it wouldn't be a reasonable
16:40presentation frankly to not discuss
16:43where some of our challenges
16:46are and they are substantial.
16:49They they reflect I think
16:51the ambition of the faculty,
16:53the opportunities in clinical
16:56research and evolving methodologies.
16:58But they also reflect I think some
17:04operational challenges that we
17:06have as a center have been somewhat
17:10slow to address in part confounded
17:13frankly by the the challenges that
17:16so many centers and departments
17:19face through the COVID pandemic.
17:22So I've listed our challenges
17:24here in three different buckets.
17:27I do want to go through these
17:29because they they are important
17:31in informing the initiatives and
17:34future growth of the center.
17:36So strategically one of our our
17:40challenges is that we largely support
17:44interventional clinical trials and
17:47pathophysiology studies like one would
17:50do in a typical supervised either
17:54ambulatory or hospital based research unit.
17:59We are relatively light in our support
18:02of other research methodologies
18:04such as observational studies,
18:07case control studies,
18:10epidemiologic studies,
18:12health services.
18:13And I I think you know my own view and
18:18this is just a personal view is that
18:23the center needs to have a broader range
18:27of infrastructure to leverage those
18:30other forms of research methodology.
18:33We have certainly have plenty of very,
18:35very distinguished faculty in those areas,
18:38but they don't benefit in the same
18:41way and with the same magnitude that
18:44investigators who use either the
18:48GCRC or HRU or use do interventional
18:54clinical trials currently benefit from.
18:57And this is common I think in
19:01historically rooted in the priorities
19:04of Ncats with the CTSA awards and
19:07that is changing very rapidly.
19:09And I think our center needs to to
19:14help generate A strategic discussion
19:16with the faculty and the leadership
19:19of the school in this area.
19:21We like all clinical investigators have
19:27a real moral and practical imperative
19:30to conduct generalizable studies and
19:33we unfortunately do not reach all
19:37relevant patient populations that we
19:39have an obligation to serve clinically
19:42in our clinical research protocols.
19:44So
19:47designing new methods to enfranchise
19:52populations who have historically
19:55been disenfranchised to engage in
19:58clinical research is an area that's
20:01particularly compelling and that we have.
20:03A lot of interest and a lot of leadership in,
20:08but it would not be correct to say that
20:11we are where we want to be in that area.
20:15Ncats, the NIH sponsor of the Ctsas is
20:20moving very aggressively towards community
20:23based research and translational science.
20:26The days of them supporting clinical
20:30research infrastructure say in A
20:33in a traditional hospital research
20:36unit or ambulatory research unit,
20:39I think those days are either
20:42ending or ended.
20:44They they have really changed their
20:47focus in a important way and and
20:50and I think in ways that are a
20:54bit precipitous for some of us.
20:56But I think have a have a distinct rationale.
21:02One of our challenges strategically
21:05in the center is that we,
21:08we have leadership at the associate and
21:13Deputy director level of faculty and
21:16many of them are in positions where
21:19they're not exactly sure what their
21:22authority and responsibility are.
21:24And that's not the faculty's fault,
21:26that's our fault.
21:27We haven't done a good job of of
21:30conveying that and organizing it. And
21:34we also have been concerned
21:36that we don't have a sufficient
21:39faculty voice historically in YCCI
21:45and that's an obvious and significant
21:49missed opportunity for the
21:52center on the operational side.
21:54I would say that partly
21:57because YCCI grew so rapidly,
21:59many of the work flows and operational
22:03changes were made in response to a crisis.
22:08And it has a bit of a, at least
22:11looking back over the last many years,
22:14a bit of an ad hoc feel to it.
22:16And so we're really trying to take
22:21apart and understand our work flows
22:24because they are too complicated,
22:27they're relatively inefficient
22:30and most importantly,
22:32they don't really consistently provide
22:37customer service that our faculty deserve.
22:42We have a broader problem and this
22:45is AI think a issue across clinical
22:48research and that is that we have
22:50relatively low accrual rates of
22:53research participants and we have a
22:56number of studies that unfortunately
22:59don't reach their their target
23:01accruals and therefore are impaired in
23:05their ability to answer the question
23:08that they originally set out to do.
23:12Of great concern is that if we
23:15are asking research participants
23:16to consent to a study protocol,
23:20we would all like to be able to
23:23have a high degree of confidence
23:25that that study protocol would be
23:28successfully completed to fulfill
23:30that obligation to participants.
23:33That's aside from all of the financial
23:37and really dispiriting aspects there are
23:40when a study doesn't achieve its goals.
23:45As I indicated, YCCI is only one
23:48of several forms of infrastructure.
23:52And so we have a kind of a federalized
23:56set of Research Services and then
23:58we have more of a states rights,
24:01decentralized form of services.
24:03And I think one of the benefits of having
24:07both and that is having a decentralized
24:11service component is that individual
24:14units and departments have been able
24:17to craft research infrastructure in
24:19a way that meets their unique needs
24:22and addresses the questions that are
24:25most important to their faculty.
24:27The downside is particularly on the in
24:32the areas of of the financial practices
24:34in those decentralized center centers
24:38and the compliance and regulatory issues
24:43there are potentially significant.
24:46So one of the conversations that we
24:49will be having as a as a organization
24:53is how how can we create flexibility
24:56at the department level,
24:59not fix what's not broken,
25:02but also ensure that there's financial
25:06and regulatory integrity throughout
25:08our clinical research portfolio.
25:15We also have significant staff
25:18recruitment and retention issues
25:21that that YCCI has multiple PhD
25:25level research administrators
25:27who frankly teach me every day,
25:31but it's hard to find them and hard
25:34to recruit them And we we've been
25:36able to do so largely because we've
25:39offered a hybrid workplace environment.
25:41In some cases we've offered work play remote.
25:45So we are as a center and every
25:50time I say this I I'm stunned by it.
25:5330% of our staff reside outside Connecticut.
25:57So it's a
26:02the good news is that we have some
26:05extraordinary people and we're able to
26:08expand the pool of of applicants for
26:11positions that that the the challenge
26:14is that it creates real practical
26:17issues as we try to create community
26:20and connectedness not only within YCCI
26:23but between YCCI and our faculty.
26:27It's not unique to our center obviously
26:29this is we're seeing this in just about
26:32every part of academics and just about
26:35every employer group and industry.
26:37But it is, it is nonetheless
26:39a challenge for us
26:42on the financial side. The
26:47the biggest challenge we have is
26:49that that institutional subsidy
26:51that nearly $25 million that I
26:54referenced earlier has grown very,
26:57very substantially over the last
27:00five years and it's grown at a
27:03rate that is not sustainable.
27:05So the good news is we've expanded clinic,
27:07expanded clinical research.
27:09The the not so good news is that
27:13we've done so at at really high
27:15cost to our supporting institutions.
27:19And as the fiscal climate changes
27:22and their costs go up,
27:24it's increased going to be
27:26increasingly difficult for the
27:28health system and the school to
27:31support us at the current level.
27:33Our cost recovery for the services
27:37is quite inconsistent and and and
27:41really way below what our peer
27:45organizations both charge and recover.
27:48So we're taking steps to to change that.
27:51We will always want to support
27:54unfunded studies but the question
27:57is I think we we have had it nearly
28:01just say yes policy and the question
28:05is should we put processes in place
28:09that filter out the least promising
28:12studies for that free support.
28:16And then lastly and not surprisingly
28:19Ncats and the regulatory agencies have
28:22a growing number of unfunded mandates
28:25that that creates a lot of pressure
28:28on the on clinical investigators
28:30in general and certainly YCCI.
28:34So what are we doing about it?
28:38I'll just run through these quickly.
28:40We have a series of faculty advisory
28:43committees and thankfully there's
28:45a number of faculty from psychiatry
28:48on these committees and we are
28:52restructuring the faculty director roles.
28:54So we are really trying hard to
28:58increase the faculty voice within YCCI.
29:01And these advisory committees have
29:03been meeting for about four months now
29:06and they've been a remarkable source
29:10of advice and input that's really
29:13helped materially shape our thinking.
29:16We are working hard to integrate
29:20and expand community engagement.
29:22We have, we were fortunately,
29:24we have two national leaders in this area,
29:27Marcella Nunez Smith,
29:29who's the Deputy Director for Community
29:32Engagement and Administrative
29:34Leadership from Tisha Johnson,
29:37who's in a newly created role
29:39focused on our external partnerships.
29:42And we're working very diligently
29:45to try to expand local partnerships
29:48as well as national collaborations,
29:51particularly with other Ctsas.
29:54And then as you know from some
29:59of the e-mail traffic,
30:00there's been a very important
30:03series of strategic conversations
30:04between the school and the the all
30:07New Haven health system to expand
30:10clinical and translational research.
30:12There will be a webinar or a town hall,
30:15I guess more correctly led by Dean Brown
30:21and and CEO O'Connor next Thursday at 11.
30:26I encourage you to tune into that.
30:28If you can't,
30:30there's a a document that's been
30:33produced that has a very thoughtful and
30:38carefully crafted strategic planning
30:40document that came as a result of a
30:44strategic planning committee chaired
30:46by Brian Smith and Peg McGovern.
30:49So I encourage you to look into
30:54that On the operational side,
30:57this is where where we're
31:00really working feverishly.
31:01I think you know we have ambitions to expand
31:04our footprint of research methodologies,
31:08but I think we're our enthusiasm
31:10to do that is tempered a bit by
31:12the fact that we have to get our
31:14operational house in order.
31:16So we're reorganizing
31:18the center significantly.
31:19I'll show you snapshots of that
31:23designed really around this theme of
31:26customer service and and to enhance
31:29the investigator services available
31:31to our faculty and our trainees.
31:34We're alpha testing currently a
31:38feasibility protocol review process
31:40that we hope will enable us to
31:45determine whether studies that we're
31:50supporting are ones that have a
31:53reasonable likelihood of reaching
31:55their accrual targets and have
31:58a reasonable financial plan.
32:00And really to try to convert this
32:03feasibility review process into an
32:06educational process where we can
32:08offer additional ideas and hopefully
32:11helpful tools to investigators
32:13to increase the likelihood that
32:16their protocols are successful.
32:18We've modified the monitoring and
32:22project management plans of investigator
32:25initiated trials particularly
32:27those in which Yale holds the Ind.
32:30We've had a one-size-fits-all and that
32:34one size has been very expensive and
32:38and presume that all studies are high risk.
32:42We've now changed that approach.
32:46We have a group that's going to be
32:49meeting the end of this month to
32:51make some recommendations on how
32:54we can adopt best practices for
32:58more effectively recruiting and
33:00retaining research
33:02participants. And then we're also
33:06looking at the feasibility and
33:09advisability of mandating use of
33:12clinical trial management software
33:14and electronic data capture,
33:16particularly under circumstances
33:18where studies are subject to
33:22invoicing and and and financial
33:25scrutiny as well as compliance risk.
33:28Right now it's advised but not
33:30required and and we have run into some
33:32problems when it's not used properly.
33:37On the financial side, we have
33:40increased our rates for our services.
33:42They were set at historically
33:45low levels and hadn't been
33:47increased for about five years.
33:52Even the rates that they were increased to
33:57has not come close to covering our costs.
34:01So we're projecting that that
34:04$5,000,000 in service revenue that
34:06I showed you in the pie chart will
34:09will grow to about 10 or $11 million
34:13within about four or five years.
34:17Those rates that we're increasing our
34:20our prospective that is they're not,
34:22they're they don't impact existing trials.
34:27We're trying to work internally
34:29to have more transparency.
34:31We're giving our associate directors
34:33their budgets to manage that surprisingly
34:36hadn't been done previously.
34:39The school is about to announce an increase
34:43in the rate charged to industry sponsors
34:47for indirect costs on industry trials.
34:52And then coming on the heels of
34:56those two pieces of bad news,
34:58namely the rates for services
35:00and the indirect rate we are,
35:02we have a draft proposal that we're
35:05getting input on to provide a voucher
35:08to offset a portion or in some cases
35:12all of the cost of YCCI services.
35:15And I'll show you more about
35:16that in a second.
35:21So our structure is shown
35:25here administrative structure.
35:27Brian Smith and John Crystal
35:31serve as our Co Pis for the CTSA.
35:34And John as you know Focus is
35:39also the Co Director of YCCI.
35:42We have a a new role for Tisha Johnson
35:47who was formerly our Chief Operating
35:50Officer as I mentioned and Brian Severe
35:53is our new Chief Operating Officer.
35:55And I want to just expand on this area
35:59on the right just to to highlight
36:01what I hope will be important
36:04benefits for our faculty and that is
36:07this investigator services group,
36:09which is really where most
36:13faculty interface with YCCI.
36:15So we're creating 2 new organizational units.
36:19The first one is called protocol design,
36:21development and feasibility.
36:22There will be a single portal of entry
36:26electronically into YCCI and then a
36:29range of services that we'll provide
36:33to aid in the conceptualization,
36:36design and ultimately development
36:38of clinical research protocols.
36:41Investigators can choose one or all of
36:45these services at this initial stage.
36:48Then once they're ready for activation,
36:53they'll go to the second unit from
36:55the left called protocol activation
36:57and life cycle management.
36:59These services that are listed here
37:02are scattered organizationally in
37:04ways that make it difficult to
37:07both track the work,
37:09hold ourselves accountable and importantly,
37:11inform faculty of the status
37:13of their protocols.
37:14We also have a prohibitively long
37:19protocol activation time that not
37:22only and very importantly frustrates
37:25the daylights out of faculty but is
37:29really discrediting with research
37:31sponsors because they they often have
37:34very aggressive timelines and we just
37:37simply don't meet those timelines.
37:39So those functions are being reorganized
37:42and and the workflow is being re
37:46crafted to make it easier to track and
37:49hopefully more timely and efficient.
37:52We will be putting all of our
37:56workflow on a Salesforce platform
37:58in early next calendar year,
38:00so faculty can access Salesforce,
38:04find out the status of their protocol and
38:08who to contact if they have questions.
38:10So we're trying very hard to make these
38:14processes more responsive and timely.
38:18The clinical research operations where
38:20a lot of our services are housed
38:22is largely unchanged and similarly
38:26regulatory and compliance affairs.
38:30So really important reorgs from
38:33our point of view.
38:35The protocol design development
38:37and feasibility will have protocol
38:39development pods with project managers,
38:43a data management and biostats core.
38:46We will be taking moving a substantial
38:51portion of the biostats functionality
38:54out of Wycas and moving it under
38:58YCCI to facilitate the connections
39:01with our faculty.
39:03And then we'll have this feasibility
39:05and intake process managed separately
39:10and the protocol activation
39:11right now we we have it separated
39:14into non oncology and oncology.
39:16We still do their the budgeting
39:19for the Cancer Center that is
39:21going to migrate to the Cancer
39:23Center and we will do the financial
39:26work on non oncology studies,
39:33this risk based approach to Yale
39:37sponsor investigative studies.
39:39I'll just summarize briefly.
39:42I don't know if you have a tradition to of
39:45making your slides available to the faculty,
39:47but I can certainly forward these
39:50these slides to Stephanie and you're
39:53welcome to hang on to them and
39:55look through them at your leisure.
39:57Basically what we've done is said not all,
40:00not all protocols have the same risk.
40:02So let's divide them into two subsets,
40:05high risk studies where we'll do the
40:07full throated monitoring and low risk
40:10studies where we'll modify the monitoring
40:13plan commensurate with the low risk.
40:15The the benefit here is that it's
40:18a lot less expensive in people
40:20time for the low risk monitoring.
40:24And it's also possible that
40:26investigators can do their own
40:28monitoring under certain conditions.
40:30So this is being implemented.
40:32It's awaiting very final approval from HRPP,
40:35but we are already starting to
40:38engage investigators in this,
40:42the rate site for our services.
40:45I mentioned earlier we've
40:47communicated these in emails,
40:49but just the highlights,
40:52we we never really had a system where
40:56we pegged our rates to our costs.
40:59So part of the reason our institutional
41:02supplement is so high is that we are,
41:06we are basically subsidizing the sponsors
41:11by providing institutional resources
41:13to offset the cost of our services.
41:17And while you know I think most
41:20of us we are enthusiastic about
41:22doing so for internally funded
41:24grants and federally funded grants,
41:27We are not enthusiastic about doing
41:29so for industry sponsored grants which
41:33in in which we have this untenable
41:36situation potentially of of being a non
41:40profit but supporting for profit entities.
41:43So because of the increase in cost and
41:47because our last rates were never pegged
41:51to costs or changed for multiple years,
41:54we have a big jump in our our rates
41:59in some cases as much as twofold.
42:02And those rates are being implemented
42:05only in a prospective manner namely on
42:09grants that are being budgeted now.
42:11Going forward,
42:12the old rates will be retained
42:16for existing rates.
42:17We were quite concerned that the higher
42:21rates if instituted across the board,
42:24while it would be financially
42:26beneficial for YCCI and our
42:29sponsors sponsor institutions,
42:31it would be very detrimental
42:34to existing research studies.
42:36So we're holding off on that and
42:39the school has been very generous in
42:42supporting a more delayed timeline
42:44so that we don't disrupt clinical
42:46research protocols.
42:51So this is going in effect as of
42:55budgets formulated from 10:30 forward.
42:58The formula is that we're applying
43:02rates that are reflect 200% of
43:05our costs for industry sponsored
43:08trials and 90% of our costs for
43:12individual investigator initiated
43:15studies and NIH and foundation
43:18and internally studied sources.
43:24We're also as I mentioned piloting
43:27this feasibility review process.
43:28I won't go through it in in detail.
43:30A number of departments and perhaps
43:33even psychiatry have experience
43:35with some of this and I I already
43:37summarized kind of the general
43:39approach and rationale for this.
43:43What we haven't rolled out
43:44yet for broad comment,
43:46although our faculty advisory
43:47committees have is a voucher program.
43:49And the idea here is that there are
43:54groups of people and perhaps types of
43:57studies that we want to contribute to
44:00offsetting the cost of executing those
44:04studies to to help those individuals
44:07or those studies take flight.
44:10So we've developed some eligibility proposed
44:13eligibility criteria that are shown here.
44:16It's basically everyone on the campus with
44:23a Yale appointment is potentially eligible
44:28and the only ones that we're
44:31excluding are individual projects
44:33funded by commercial sources.
44:37So the approach that we're suggesting,
44:39again, this is still in very early stage.
44:43So this is the first departmental
44:44meeting I've kind of shared it with.
44:46So please take it with a grain of salt.
44:49We we have a lot more refinement to do here.
44:52The idea would be that there would be a
44:55sliding scale of financial support for
44:58these vouchers that YCCI would fund,
45:01depending on the person and the circumstance,
45:05anywhere from 25 to 100% of the voucher cost.
45:11The department, center,
45:13school or section would provide
45:16the balance 0 to 75% depending
45:19on the awardee or the project.
45:23Because we don't know exactly
45:25what this would cost,
45:27we're proposing to set a cap of
45:35$500,000 in the first year.
45:38And this, this is just a back of
45:41the envelope calculation based on
45:42the rationale that our services
45:45are projected this year to
45:47generate about 5 million dollars,
45:5010% of that seems like a reasonable
45:53percentage to commit to a,
45:55a voucher program at least at first pass.
45:59We would then take 10% of that 5 million
46:02or 500,000 and make it available on
46:05a quarterly basis so that we could
46:08distribute that 500,000 / 4 quarters
46:11of an academic year that set a cap
46:15of $10,000 either per investigator,
46:18per year or per project.
46:22We have a lot of work to do on
46:24how to execute the voucher credit.
46:28That's at this point all to be determined.
46:35So in summary, I want to leave you with
46:39the notion that I hope that YCCI is an
46:42important source of clinical research
46:44infrastructure and training across
46:47the university and the health system.
46:50That all forms of clinical research
46:54and particularly infrastructure
46:55really requires a much higher level
46:58of discipline and and commitment to
47:02operating that infrastructure in a
47:04in an efficient and effective way.
47:08All design with the goal of of helping
47:12people successfully complete protocols
47:14and to do so in a way that's safe for
47:18human subjects and meets all of the
47:21applicable regulatory requirements and
47:22also has a path of financial sustainability.
47:28And I think what it what it really says,
47:33I think strategically is centers like
47:36YCCI have to really professionalize
47:39all of these services and really take
47:43seriously the the opportunities to
47:46discover new approaches to treatment
47:49of individual patients and and
47:52populations of patients.
47:54I hope I've shared with you what
47:57is been a very,
47:59very active several months of of changing
48:02our policies and our procedures to be
48:04more responsive to the research community.
48:06We are not where we want to be yet,
48:09but we're very hopeful that over the
48:12next many months our services will begin
48:15to improve and we're going to rely on
48:19the feedback of faculty to tell us how
48:21we're doing and where we can improve.
48:24So I hope you will feel very comfortable
48:27sharing that feedback with us and then
48:32you know hopefully we will continue to
48:34have regular meetings of the leadership
48:37of a center and and and to get
48:40iterative feedback and and disseminate
48:43information to the research community.
48:46So there's a lot of work ahead.
48:48I I do hope I've left you with the
48:51notion that there is an extraordinary
48:54opportunity if we do this well to
48:58leverage discovery on this campus.
49:00And for me personally,
49:02coming back as a member of the Yale
49:05community after 16 years in in Boston,
49:09as Doctor O'Malley indicated has really
49:12been a a wonderful reminder of the
49:15creativity and and the aspirations
49:17of of our faculty and trainees.
49:20So it's been a,
49:21it's been a real privileged time for me.
49:24So thank you.
49:28Thank you so much.