Chapter 10: The Provost's Office: Acting on a Mandate and A Personal Goal
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Description
Dr. Dmitrovsky begins by sketching the major functions of the Provost's Office and then talks about initiatives he has undertaken to address low faculty morale. He talks about the importance of listening and explains how he set about hearing faculty concerns. He first explains initiatives set in place to address the faculty's impression that the depth and scope of excellence among the current faculty is unrecognized: the R. Lee Clark Fellowship Program; the Clinical Innovator Award Program. He discusses investments made to relieve the monetary burden of running clinical trials and conducting genomic testing. Using examples, he explains the measures taken to relieve many instances of regulatory burden.
Identifier
DmitrovskyE_02_20150506_C10
Publication Date
5-6-2015
City
Houston, Texas
Interview Session
Topics Covered
The University of Texas MD Anderson Cancer Center - An Institutional Unit; The Administrator; The Professional at Work; Leadership; Mentoring; Research, Care, and Education; Building/Transforming the Institution; Growth and/or Change; Obstacles, Challenges; Institutional Politics; Controversy; MD Anderson Culture
Transcript
Tacey A. Rosolowski, PhD:
So, Dr. Dmitrovsky, last time we talked about your research, and we kind of focused in general on your mandate of managing change at the institution. And today, I wanted to focus a little bit more on the role of provosts in the provost's office. And to get a sense of what was your mandate when you assumed this office? What did the executive leadership of MD Anderson expect you to achieve? And what was perhaps your personal take on what you wanted to achieve when you assumed that role?
Ethan Dmitrovsky, MD:
So my charge in coming to MD Anderson was to continue the good work of the provost's office in all of the traditional realms, that include recruitment of outstanding faculty, retention of outstanding faculty, recruitment of outstanding students and trainees of all stripes, and to put in place process and procedures that would facilitate the recruitment of trainees. And also, to oversee our school of health professions, which is an undergraduate degree-granting program. So we are a distinct institution in many ways. And we are potentially unique in one way, in that we have an undergraduate school.
Tacey A. Rosolowski, PhD:
Why is that significant?
Ethan Dmitrovsky, MD:
Because in a university, obviously, there's undergraduate schools, but we are a freestanding cancer center. I am not sure whether there is another freestanding cancer center that gives an undergraduate degree, because that degree is oftentimes part of a traditional university. So charge was in all of those additional realms, in addition to the other traditional realms, is to oversee conflict of interest policies to adjudicate questions of conflict of interest, questions of research integrity. And to help facilitate the Moon Shots Program, as well as facilitating the movement of our discoveries, not only from the bench to the bedside, but into the community. Which, of necessity, dictates some commercialization. So those were the charges that were given to me when I came here, which are pretty traditional scope of responsibilities for someone with the title of Chief Academic Officer or Provost. So that would be my response to the first question you had. The second aspect is what was my personal goal. And so I was aware of creative sorry, I was aware of the need to address morale on concerns of the faculty and the staff, prior that existed prior to my arrival. And I sought to do all that I could to help address those concerns.
Tacey A. Rosolowski, PhD:
When you arrived, how did you go about kind of getting the lay of the land? You know, what was at work with those issues amongst the faculty and staff?
Ethan Dmitrovsky, MD:
So I think it's very important to listen and to learn, and not to come in with the preconception that you know how to make an institution better if you've never been at an institution before. I think it's presumptuous to say that you know better from the outside of an institution or from another institution when there's so much content expertise acquired by faculty and staff and students and trainees who are here. So the first thing that I set out to do was to listen and learn, and how I went about that is that we have then when I arrived, we had 66 departments in 10 divisions. And I visited with each and every one of them. I also visited in small groups with all of the direct reports to me in nonacademic departments, in academic affairs. And the research finance area, visa, and all of the many areas that roll up, which are many, many departments, and many people. So I actually met with all of the nonacademic departments, and that took almost half a year, with a concerted effort to have multiple meetings a day, or try to have a meeting every day. And I learned firsthand about the pressures, tensions that staff and students and trainees of all stripes had, as well as faculty. And it was clear to me that part of the anxieties people had did reflect the tensions that are now evident nationally in all institutions. Flat or reduced NIH funding, decreased sources of funding beyond the NIH, healthcare reform, which is still leading to anxiety, and uncertainty because we don't know what Obamacare is going to look like as it evolves. It's still evolving as it's being implemented. In a sense, both in the clinical rank clinical faculty ranks, the clinical care provider ranks, and in in the research faculty, the scholarship intensive faculty, and those with whom they worked, two communities were feeling under tremendous pressure, because in large part, the changing healthcare economics, and the changing research environment. So what I felt I could do to be helpful would be to implement some new programs that would be of support across the clinical and the basic scientific translation and population science faculty.
Tacey A. Rosolowski, PhD:
I'll ask you about those in a moment, but what else did you learn about kind of sources of anxiety and tension with the faculty?
Ethan Dmitrovsky, MD:
I think there was an impression that some faculty members gave me, when I arrived, that there was insufficient recognition of the depth and scope of excellence that already existed here in the ranks of the faculty of all backgrounds. And they felt that that needed to be recognized more. And that touched a responsive chord, in my mind's eye. And so I was focused in my endeavors at first to build programs that would help faculty, or were already here, rather than emphasizing recruitment of faculty. So to give you an example, we created the R. Lee Clark fellow program, which was named in honor of our inaugural president, R. Lee Clark. And the recipients were mandated to be junior faculty, at the assistant to mid-associate professional level, mid-time and rank. But the criteria was that it had to recognize faculty who were here, not who could be recruited. Now, once they came, they'd be eligible. So I wanted to change a little bit of the balance from recruiting being the emphasis to also fostering the cause of those who were here, because this is what I heard. Secondly, we created an analogous program that we call the clinical innovator award program that was focused on those clinical faculty whose time and effort were at least 70% clinical effort. That was the other broad theme that I heard in those 76 meetings, is that the clinical faculty with the emphasis on scientific excellence and translational excellence, felt that they were not recognized sufficiently. And so once again, this was tailored to the clinical innovator award was tailored to faculty who were here. So it wasn't a recruitment tool. And that they would be able to the R. Lee Clark program was a $100,000 award, the clinical innovator ward is a $50,000 award and that they would be able to facilitate their scholarship. So that was meant to respond directly to the feedback I received that there was more emphasis in a group of faculty feedback that I received. Their feedback indicated there was too much emphasis, maybe even imbalance, of bringing people here when there was already in-depth excellence. The third way I responded to that is that I had heard repeatedly that MD Anderson's translational community that was running clinical trials felt that there was undue costs associated with the conduct of clinical trials, and I should do something to reduce not only the regulatory burden, which is something I'll talk about in a moment, but also that I could that I would be well served, the feedback I received, by addressing some of the actual financial costs associated with trials. And so I thought that was a very helpful feedback, and I mobilized $24 million to be distributed over three years. And we're pretty much on track of distributing about eight million a year to offset the cost of diagnostic services for clinical trials, with a peer review committee determining the most innovative trials that we would support. And this recommendation was to reduce the rates to 59% of the current rates, was a faculty-led panel that made these recommendations. Thought it was important to embrace the recommendations of the faculty, and all I did was to implement those recommendations. And so we've done it on a test basis, and what I'm pleased to have in the record is that so far, we have now supported by differing diagnostic services costs in a peer review manner that is a committee of peers' reviews of scientific content. We've now supported 118 trials. So if you think of a faculty roughly of 1,700 faculty members, many faculty members have been touched by this support. And I think this has done a lot of good for our patients, because the cost of the trials have been taken out of the equation, to some extent, by not having a commercial biotechnology pharmaceutical partner saying, "œWe don't want to conduct our trial here at MD Anderson, because your costs might be too high. We also set aside $2 million to support innovative clinical trials that were developed here at MD Anderson that would go through a separate peer review process to support, to provide real financial support for these trials. Oftentimes, it's very difficult to receive NIH funding for such trials. And so we've supported a number of those trials, too, as you can imagine. That's something that touches the lives of many faculty here. So those are examples of the response, the feedback that I received and the response the provost office had, and this is not being done by me alone, but by the entire team. And all of these decisions were vetted by the entire provost office team. And then we heard another feedback that was more patient-centric, but also woven into faculty. And that was that we needed to do something decisive to defray the costs of genomic testing. And so-called CLIA testing, which is testing that results can be used to guide clinical management. And so we set aside another substantial investment in concert with the IPCT Institute, led by Drs. Mendelsohn and Mills in a partnership model where we partnered in the financial expenses. We've set aside $10 million to make CLIA testing, genetic testing for our patients, their tumors tested, and patients eligible for clinical trials to make those tests free to patients. So we've made those tests free to patients as part of a clinical trial so that we would learn what that information gained was how we used that information. And did it mean the patients then had more ready access to innovative clinical trials? And so that experiment is underway, and we've now accrued over 400 patients that's drawn on. Very pleased that the provost office again a team approach made that commitment. And that experiment was one that was done in partnership with the pathology department, with IPCT, with a number of translational investigators. And I have deferred to them all of the data analysis and all of the I hope they'll publish their findings as well so that the scientific community can see these investments that we've made. I guess I've talked about two large topics: one, what we've done to support to support faculty, the other what we've done from a research point of view to support patients in a research driven patient care model. And the third is, what I heard repeatedly in those many meetings, is there's too much of a regulatory burden. And I felt that was a most warranted critique. And unfortunately, I might say sadly, this is a growing trend, that MD Anderson or any individual institution can claim any undue credit, to use sort of an ironic use of the word. And I set out to try to begin to reduce the regulatory burden. And so there are many things that we've done in concert with a number of faculty groups. So I receive feedback from Dr. Hagop Kantarjian that there was undue delay in the conduct of clinical trials because there was an additional layer of biostatistical review that was put in place. In a nutshell, you can't, of course, conduct any human subject trial without robust biostatistical review. Everyone agrees. And what we were finding is that we would have, as an example, an MD Anderson faculty member who happened to be a quantitative scientist. On the protocol that was being submitted, if it were an investigator initiative protocol, and yet we would have another quantitative scientist, also from the same department, here at MD Anderson who would review the work of their colleagues. And of course, that's a reasonable, very reasonable to have peer review. But there was tremendous delay that was put in place by the secondary biostatistical review, and the experience was that it didn't change the final outcome. And this was true over 80% of the time. And so we brought together a group of content experts, including the department chair, the relevant IRB community members. And to ask, is there without being directing in any way, without being directing but to ask, is there any other process that we could put in place for MD Anderson designed trials where they already had biostatistical experts? And so why would you not want to have a process that could streamline, because every day that you delay a protocol being implemented, is a delay and a patient hopefully benefitting. And what safeguards could we put in place so there could be, if needed, an independent biostatistical review? And so we put in place a streamlining process where there'd be an initial review that would hold up the second the actual review by the IRB, and we would a priori assume that we had equal content expertise from a discipline. And so we would only delay the protocol if there was some major flaw in the biostatistical analysis, because as in a second opinion for a patient's case, you sometimes never get identically the second opinion. And so I have a second opinion, was there was a pressing need for a second opinion where the outcome might be different. And so that actually has tremendously streamlined our trials, and another scenario is when you have what's called cooperative group trials that are supported by the federal government. You really have little ability to change the design of the trial. The option you have is either to accept the trial and conduct it or not, as a multi-institution. And we agreed there was really no practical reason to have a secondary review, because the parental I mean, the parent sponsor, the federal government, wouldn't permit you to change the trial. And so it didn't seem sensical sensible to have a secondary review, so we don't do that anymore. We allow the statisticians to say, is this a flawed study or not? And then we wouldn't accept the trial. And you see, you get the picture of what we've done. And so this has accelerated all of our clinical trials.
Tacey A. Rosolowski, PhD:
Yeah, I could imagine.
Ethan Dmitrovsky, MD:
Tremendously.
Tacey A. Rosolowski, PhD:
Yeah.
Ethan Dmitrovsky, MD:
And the the other process that we put in place is the federal guidelines for informed consent. There were certain mandated rules and regulations there, meaning that the actual informed consent that a patient reads and signs can be as long as twelve pages, maybe a little bit longer. And we did a review of our informed consents here, and some of them were upwards of over 50 pages, sometimes 60 pages. And so I am powered again, this was a suggestion made by Dr. Kantarjian that I should do something about this, and I thought that was appropriate. So I
Tacey A. Rosolowski, PhD:
I can't even imagine a patient actually dealing with a document of that size. (laughter)
Ethan Dmitrovsky, MD:
Well, many people would take the view that no one would read this, whether you're a patient or not. And some who I do lead clinical trials. I've never met someone who actually would read 50 or 60 pages of informed consent. So it didn't seem a sensible thing to do, so we empowered Dr. Jorge Cortes to lead this initiative, and we're now down to just about federal guidelines. And so this is streamlining the process while preserving safety for our patients. Of course, we're going to preserve safety. And another example is material transfer agreements. We had put in so many potential barriers to actually receiving the MTA, material transfer agreement, because there's always a concern that unless we thought of every scenario that someone might take advantage of an MTA, and conduct themselves in a way that would not be consistent with our core values, many layers of bureaucratic barriers were put in place, and I took the view that oftentimes, people who seek to circumvent rules are highly creative individuals, and there's no guideline you could put in place to circumvent.
Tacey A. Rosolowski, PhD:
I have to confess my ignorance here. I don't know what a material transfer agreement is.
Ethan Dmitrovsky, MD:
So if you develop a reagent in your laboratory as an example, this is meant just as an example so I get requests two or three times a week from outside of MD Anderson for reagents that my laboratory has produced. It might be a special DNA vector, they might be a cell line, they might be a mouse model that I've developed. And sometimes, these are reagents that might be a compound, that there's intellectual property associated with it. And so there's a commercialization potential, as an example. So a material transfer agreement protects the institution's interest. And, you know, you can take this to an extreme. And so, and we did. And now we don't. And so each of these these are just three examples. Each took us six months to a year and a half to implement. And so
Tacey A. Rosolowski, PhD:
It's funny how nobody sets out to be inefficient, but it develops, and then it takes a long time to unravel all that.
Ethan Dmitrovsky, MD:
Well, not only is that a truth, the way I would codify what you just said, it is very easy to create something, but very hard to uncreate it.
Tacey A. Rosolowski, PhD:
(laughter) There we go.
Ethan Dmitrovsky, MD:
And so there was a there's about a dozen examples like this that we've done. And this regulatory burden is a theme that I heard from so many faculty. And I have sometimes made the case that this is that these changes, I have not advertised, because I feel that there's a certain critical mass of change you need to make. And before people appreciate that maybe their day to day life is a little bit better.
Recommended Citation
Dmitrovsky, Ethan MD and Rosolowski, Tacey A. PhD, "Chapter 10: The Provost's Office: Acting on a Mandate and A Personal Goal" (2015). Interview Chapters. 645.
https://openworks.mdanderson.org/mchv_interviewchapters/645
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