Margaret McGovern, MD, PhD - Integrating Clinical Research with Clinical Care at Yale and Q&A

March 07, 2024

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00:00We're very honored to have
00:02Doctor McGovern join us today.
00:04Doctor McGovern received her PhD in
00:06Genetics from the Mount Sinai Graduate
00:08School of Biomedical Sciences and her
00:10MD from Mount Sinai School of Medicine.
00:13She completed her residency in Pediatric
00:16Pediatrics and Fellowship in Clinical
00:18and Molecular Genetics at Mount Sinai.
00:21Before joining Yale, Dr.
00:22McGovern was the NAP Professor of
00:24Pediatrics and Dean of Clinical Affairs
00:26at the Renaissance School of Medicine
00:28at Stony Brook and vice president
00:30of the Stony Brook Medicine Health
00:33System Clinical Programs and Strategy.
00:35Prior to assuming those roles,
00:37in 2018 she was chair of Pediatrics
00:40and Physician in chief at Stony
00:42Brook Children's Hospital.
00:44In 2022,
00:44Doctor McGovern was appointed the
00:46deputy Dean for clinical affairs
00:48at the Yale School of Medicine,
00:51the Chief Executive Officer of
00:53Yale Medicine and the executive
00:55Vice president and chief physician
00:57executive for Yale New Haven Health.
01:00And so we are so lucky and fortunate
01:02to have her join us today.
01:10Thank you. And thanks for
01:11inviting me to talk and be
01:13the final speaker of the day.
01:15But you're all still alert and awake,
01:17so this is a good sign.
01:21I'm going to tell you a little bit about
01:23some of the work we've been doing over
01:26the past year to better support clinical
01:28research throughout the enterprise.
01:30So inclusive of the school
01:32and the health system.
01:34And this is, was identified as a
01:38pillar of alignment between the School
01:40of Medicine and the health system,
01:42an important pillar to leverage
01:45the intellectual infrastructure and
01:47innovation and the efforts of the
01:49faculty in the School of Medicine and
01:51bring the findings that you all make to
01:53the bedside of the patients that are
01:55cared for within the health system.
01:57So the rationale for this
02:00joint strategic approach,
02:02I find it interesting that we had to have
02:03a rationale that is completely obvious.
02:05We should be doing this work together.
02:06But the rationale to drive this
02:08work because historically this,
02:09this wasn't really the philosophy
02:12here is to support the health system
02:14and the school's common mission of
02:16innovation in the development of
02:18preventive diagnostic and therapeutic
02:20modalities and improve systems of
02:22care to enhance health outcomes
02:24for populations of patients.
02:26Also to improve patient outcomes
02:28by accelerating the implementation
02:30of innovative new diagnostic
02:32and therapeutic approaches.
02:33I think we have huge opportunity here.
02:36The keyword in this one being
02:38accelerating that we should be nimble,
02:41we should have these systems in place to
02:43bring to the bedside discoveries that
02:45we make here in our own School of Medicine.
02:48You know one frankly that sticks
02:50out of my mind was the development
02:52of the drug here to delay the onset
02:55of diabetes in in children.
02:58And we were not the first people in
03:00the country to give that drug to a patient.
03:01So that's our lack of nimbleness to be
03:05able to stand up a program supported,
03:07get it done,
03:07get it over the finish line.
03:09And I know we can do this work.
03:10We just have to have the systems in place.
03:12And then of course to increase access
03:15to patients who were seeking enrollment
03:18in clinical research protocols.
03:22Also to increase recruitment and
03:24retention of outstanding clinicians,
03:26staff and trainees by providing these
03:29opportunities to innovate and making
03:31it easy for them to see their work
03:34realized in the clinical environment.
03:36And I've spoken to a lot of mid
03:38career faculty in the 8-9 to 20
03:40months or so that I've been here.
03:42And I've heard from many of them that
03:45this is they find it very difficult to
03:47navigate our complex health system to
03:49bring to the bedside or to bring their
03:52programs or their ideas to fruition.
03:54And we really have to do a better
03:56job with that on the clinical side
03:59also to devote some attention to
04:01increasing industry sponsored clinical
04:03research to provide all relevant
04:05trial modalities for our patients and
04:08balance our clinical research finances
04:10to release more opportunities for
04:12highly innovative research projects.
04:14So you know like in most things in life,
04:16one also has to be fiscally responsible,
04:18have financial models that are
04:21sustainable and diversifying our research
04:23portfolio is another way to do that.
04:25Want to leverage the broad diversity of
04:28academic strength across the university
04:29and health system and enhance clinical
04:31value in systems of care through research
04:34related to healthcare delivery science.
04:36So there was a work group constituted
04:39to take these rationale and principles
04:42and try to bring life to them in
04:46meaningful ways that would impact how we
04:49do this work across the health system.
04:51And this was a collaborative effort
04:53with Brian Smith and Dave Coleman and
04:56Yolanda London who did a stellar job
04:59helping to coordinate this group on one
05:01of the first things we went out with,
05:04which was trying to wrestle the
05:06issue of having a single IRB.
05:08But there is a whole work plan for this
05:11that this group developed to really
05:14figure out how do we do a better job
05:16in Bend embedding clinical research
05:18activities into our practice environments.
05:21I've also met a lot of you who are
05:23looking for spaces to bring your
05:25research patients in a proper clinical
05:27environment where it's not just a
05:28room with no windows and no sink,
05:30but it's a proper place to bring a patient,
05:33which is what we need to be doing.
05:35And everyone trying to figure
05:36that that out for themselves,
05:38which you know is really unnecessary
05:40if we could get it together to
05:43identify these spaces,
05:44you know strategically place them across
05:46our geography in our outpatient locations
05:48available to any investigator to come.
05:51So everyone's not sort of trying
05:53to create that for themselves and
05:56with great difficulty I might add in
05:58great expense and sometimes bringing
06:00patients to places that you know you
06:02really don't want to bring them,
06:04you know they should come to a a setting
06:06that's like any clinical setting.
06:08They'd go for their care so that
06:11you have all of that respect and
06:13infrastructure built into the
06:15encounter with your research patients.
06:18So some of the strategic objectives
06:20of this work group were to create a
06:23governance structure to facilitate
06:25and coordinate clinical research
06:27across the entire enterprise,
06:29build extended infrastructure
06:31to support clinical research
06:33throughout our catchment area,
06:36enhance discovery through strength
06:37and biomedical informatics,
06:39data science and precision medicine.
06:41Sort of getting to Holland's comment about
06:43getting access to data and how do we,
06:45how do we clear the path for that to happen?
06:48Doing it in a safe,
06:49responsible, compliant way,
06:51but not putting so many barriers
06:54in place that it makes it very,
06:56very difficult for people to
06:58access information they need to
06:59do their research and foster an
07:01understanding of an engagement and
07:03research across the health system.
07:05We've got, we've got a fair bit to do there.
07:08You know the leadership in the
07:10health system is has not been well
07:13connected back to what goes on,
07:14what goes on across the street
07:16and school medicine.
07:16What are those faculty doing all day?
07:18And they really need to gain an
07:21appreciation of what your work is,
07:22how you spend your time,
07:25what it takes to write in an IH grant,
07:27which is a huge piece of work and and
07:30to really understand the power of the
07:32research that's going on in the school.
07:34And I think,
07:34you know,
07:35there's been a lot of progress made
07:37as we've been taking this alignment
07:39path at one of the health system
07:41board meetings as there was a
07:43session actually you spoke at it,
07:45you know,
07:45about what what innovation and
07:47science is going on in the school.
07:48That was I think one of the most popular
07:50things the trustees had heard in a long time.
07:51They were very excited by this.
07:54It was like wow,
07:55you know,
07:56this is right here and we haven't
07:58been leveraging and capitalizing on
08:00it and you know, and celebrating,
08:02you know this work and how we can
08:04bring it to the bedside of the
08:06patients in our own health system.
08:08And it's not just you know, patient,
08:11direct, patient oriented research.
08:13You know,
08:13I've heard a lot about some of the
08:15work that goes on in our division
08:16of general internal medicine and
08:17some of the work that they do
08:18that nationally is recognized,
08:20embraced and integrated into thinking
08:23about planning for healthcare.
08:25And a lot of those initiatives
08:27we don't deploy here.
08:29I mean you know,
08:29this doesn't really make sense.
08:30So we have to line these things
08:32up better that you know,
08:33we're really leveraging all of the
08:35assets that we have at our disposal.
08:38So the specific goals of this work
08:40group or you know to develop governance,
08:43you need strong governance to make
08:46something sustainable and to get buy in.
08:48So the governance structure proposed
08:50is a joint clinical research strategic
08:53planning group charging YCCI which
08:55is of course the school program
08:59with supporting clinical research
09:00functions across the entire health
09:02system and having that clinical
09:05research space planning group that
09:07would do what I referenced go out
09:09and find what are the appropriate
09:11locations to have that touchdown
09:13space for research patients.
09:14Or maybe you need some you know
09:16small lab area in some of these,
09:18some of these locations and really
09:20understand what are the needs of
09:22our clinical investigators and help
09:24try to meet those needs and do it
09:26in a geographically dispersed way.
09:29So that patients don't have to all
09:30travel into New Haven or travel
09:31to your one location that you're
09:32able to sort of stand up.
09:34But you can go out and recruit patients
09:36from lots of locations for infrastructure
09:40is what ruined my life for a few months,
09:42helped try to create a single system
09:45wide Institutional Review Board and
09:47oversight structure for all aspects
09:49related to HRPP and leveraging
09:51the investments in YCCI.
09:53We had about 1000 meetings about this topic.
09:56But I am incredibly happy to report
09:58we got this over the finish line.
10:00This is happening.
10:00You're going to be hearing a lot about it.
10:03It was a lot of work.
10:04Obviously there were legal, regulatory,
10:05compliance, all sorts of issues.
10:07There are cultural issues,
10:09there are issues related to how
10:11siloed we are across our hospitals.
10:13There are proprietary issues and people
10:15feeling like they own this or that.
10:18Somehow we'll mess it up by
10:20by making it a single IRB.
10:22We got past all those things and
10:24it required a lot of conversation,
10:26a lot of buy in.
10:28We twisted a couple of people's arms also.
10:29But we are there and we are going to
10:32have a single system wide IRIRB and I
10:35think the more of our faculty who are
10:38working sometimes exclusively in the
10:41other hospitals in the health system.
10:44You know this is a big responsibility
10:45to our faculty to make it easy for
10:46them to be in those other settings,
10:48be able to do their research and
10:50not have to be trying to navigate
10:52you know a system in one of the
10:54so-called DN hospitals that sometimes
10:56were not created in a way that would
10:59feel familiar to someone coming
11:01out of a university setting.
11:03Because it sort of a very different
11:05mindset and approach about the
11:07responsibility for overseeing research
11:09that involves human beings also
11:12trying to create a single feasibility
11:14review framework for research
11:16studies utilizing YCCI resources.
11:18And what we found when we were doing
11:21the one IRB work was there were a
11:23lot of things being classified as
11:25human research mostly in the other
11:28hospitals that really warrant,
11:30you know,
11:30they were really performance
11:32improvement or quality improvement.
11:33They don't need full IRB review.
11:35So there's a lot to do here to
11:37really make this process nimble,
11:39keep it focused on what it needs
11:40to focus on and to take care of
11:42the the other things in a in a
11:44way that's more nimble,
11:45less resource intense.
11:47And also and we have not done this yet,
11:52putting in place you know how we
11:54can expand the investigational
11:55drug service across the health
11:57system in a seamless way.
11:59So if your clinical trial
12:01involves you know a a
12:03drug or a new agent,
12:05this would be hard to do right now
12:07across the entire health system
12:08the way that it's structured.
12:09But we can make this just like we
12:12brought together the one IRB concept
12:14much more nimble for investigators.
12:18And also a big goal is enhancing
12:20discovery through biomedical informatics,
12:22data science and precision medicine.
12:24And get then gets back a
12:26little bit to Harlan's issue.
12:27And trying to do all these things,
12:29increase awareness training
12:31and participation in biomedical
12:33informatics and data science research.
12:35Not just increase that awareness,
12:37but make it easy to do that,
12:39develop increased capacity for
12:41AI and digital technologies
12:43and implementation science.
12:44And you know,
12:45I think you're probably all aware
12:47that the Provost has convened a
12:49committee to look at AI and what
12:51does the what does the university
12:53want to do in this space?
12:55Increased partnership with the
12:57Yale School of Medicine Library.
12:59We took a big step towards this
13:01just in the past week or so with
13:04really trying to get to a single
13:06library platform across the entire
13:08health system with common resources
13:10available to faculty no matter where
13:12their privileges are right now.
13:14This is very arcane system that
13:16you know what access you get to
13:18library services depends on which
13:20hospital you have your prudential
13:22in as a physician you know which
13:24really doesn't serve us very well.
13:26So how do we make progress on that?
13:28How do we modernize the library
13:30function at places like Bridgeport
13:32and Greenwich and LMH that you know
13:34clearly aren't going to have the
13:36resources and infrastructure to develop
13:38a library like like we have here.
13:40Make HIPAA compliant electronic
13:41health record data more accessible to
13:44investigators while you know building
13:47those standards to keep it safe That
13:50around usage and training and compliance,
13:53redesigned the research
13:54function of the so-called JDAT,
13:56this joint data management group and
13:59streamline decision making for data access.
14:01We have a huge opportunity here.
14:02JDAT gets requests for all sorts of things.
14:07I'd say 75% of which don't have
14:10the value proposition for the
14:12resource that goes into them.
14:13In fact,
14:14they are asked to pull data
14:16and reports and information,
14:18a lot of it for trainees that those same
14:21people who requested never access it.
14:23So you know,
14:23this really needs to be cleaned up.
14:25This is a really powerful tool and it's
14:27fantastic that we have this group here.
14:29But access to that group and
14:31the work that they're doing,
14:32you know needs a little bit more governance.
14:35Recruiting a leader to implement
14:37precision medicine that's obviously the
14:39Dean's office function not this group's.
14:41But was in the mix of the thinking about
14:43what do we need to support such a person.
14:45And expanding the Yale School of
14:48Medicine biorepository making
14:49it increasingly accessible while
14:52consolidating individual biorepositories
14:54as you know an efficiency measure.
14:57And to make sure that we're building
15:00something that will be a a powerful
15:02tool for investigators across
15:03the school
15:06and finished on time
15:13and thanking thank you for asking
15:14me to talk to you about this is
15:16real important work a little bit
15:18tedious a little bit in the weeds
15:20but really important and it's a nice
15:22bright spot in my day to think about
15:24something other than revenue cycle.
15:29We and we very much appreciate
15:31you coming and I think
15:32you know for why wait for obesity
15:34research this is absolutely
15:36incredibly important across the
15:37system how do we get our patients
15:40in as participants into these
15:41studies and and so highly relevant.
15:43So we thank you.
15:45Any quick questions for Doctor
15:47McGovern before we continue on?
15:51Yes.
15:56So I was wondering like we're studying
15:59obesity in the determinants of you
16:02know outcome in the real world and we
16:04need the real data and you mentioned
16:07like we can you know use health record
16:09data and and and the former speaker
16:11also alluded to that that it would be
16:14great to have access to these data.
16:16But I think we should also then build
16:20consensus on how to standardize
16:22how we record data.
16:25But also maybe in case of you know our
16:28interest it would be great to have
16:31some very simple questionnaires or
16:33you know not data that would usually
16:35be there in in a health record. So.
16:38So do you, how do you see that?
16:40Is there, is there a possibility
16:43to do that throughout, you know,
16:45specific departments that deal
16:46with people with obesity.
16:48So, you know, I think it's possible to
16:52create, you're talking about collecting
16:53a new data field from every single
16:55patient and walks into the health system.
16:57Yeah, I mean I think that that that
16:59would that would go back point back to
17:01the governance part of this because
17:03on the one hand, you can't be asking
17:054000 questions of patients, right.
17:06And then there's privacy and other issues,
17:09but on the other hand,
17:10we do add things all the time.
17:11Right now we ask about social
17:13determinants of health.
17:14That's relatively new.
17:15So putting these things in is a possibility.
17:18The more that our patients engage
17:20with the portal or being able to
17:22answer some of these things, you know,
17:25before they even come to their visit.
17:26Those are all tools we need to
17:28leverage to do things like that.
17:29But I think in the end,
17:30like adding a question that you're
17:33going to ask every patient who comes,
17:34you know,
17:34there's got to be some kind of
17:35a governance decision.
17:36There's got to be somebody that
17:38decides that you know there's
17:40there's benefit from doing that
17:42because you know all of that just
17:44adds to the intake time etcetera.
17:45So definitely possible and
17:47leveraging the EMR to do that,
17:49you know I think is is a smart
17:51thing to do when you know I think
17:52we're starting to do more and more
17:54than that especially in the social
17:55determinant space which is probably
17:57relevant to obesity research.
17:59So I think soliciting input from our
18:03clinical investigators about what,
18:04what kind of basic information
18:05would you like to know about
18:07everybody just because you know,
18:09it might be useful for a study in the future.
18:11You know, I think is, you know,
18:13has merit to consider.
18:16Great. Thank you so much.
18:18And we're going to keep moving
18:20along because Dean Brown
18:21has to get to a meeting.
18:22But John, I'm sure that Doctor
18:25McGovern will answer your question
18:27after if that's OK.
18:29Thank you so much.