Margaret McGovern, MD, PhD - Integrating Clinical Research with Clinical Care at Yale and Q&A
March 07, 2024Information
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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.