
Chapter 23: Regulations on Clinical Trials and New Research Projects in Breast Medical Oncology
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Description
Dr. Hortobagyi begins this chapter by talking about how clinical trials helped build a multi-disciplinary mentality in Breast Medical Oncology. He then observes that increasing costs and institutional/national regulations on clinical trials holds back research efforts. He then explains how he developed the research infrastructure in Breast Medical Oncology, beginning with his development of clinical trials with FAC and inflammatory breast cancer. Pharmaceutical companies provided drugs for these trials and other resources. Dr. Hortobagyi describes the different cost components of a budget for a drug trial (nurses, data managers, etc.). As the numbers of trials increased over time, he explains, research simultaneously became more complex, and he gives the example of his first research nurse, who could handle eight or nine clinical trials, while today many more individuals are involved.
Dr. Hortobagyi then gives an overview of regulatory practices governing trials, which also add to the complexity of research. He notes that a few people decided to be “slippery or dishonest,” and their actions resulted in a burden of regulation for everyone that slows research. He also describes how regulation has increased the cost of health care and absorbed the efforts of the best investigators, tapping their energy for tasks that add no value to their research.
Dr. Hortobagyi describes how difficult it was to set in place all the pieces required for an optimal research structure, underscoring how important it was to strategize for resources, efficiency, and to work within budget constraints. He returns to subject of physicians who lack leadership training, and who need these skills to manage complex initiatives. Dr. Hortobagyi gives an overview of the tasks he managed: providing the highest quality of care; insuring that all faculty and staff work at their highest level; influence the development of the Breast Center; increase research productivity, coordinate research activities, ensure that research breaks even; foster careers; educate the next generation.
Identifier
HortobagyiGN_04_20130128_C22
Publication Date
1-28-2013
Publisher
The Making Cancer History® Voices Oral History Collection, The University of Texas MD Anderson Cancer Center
City
Houston, Texas
Interview Session
Gabriel Hortobagyi, MD, Oral History Interview, January 28, 2013
Topics Covered
The Interview Subject's Story - The AdministratorBuilding/Transforming the Institution Multi-disciplinary Approaches MD Anderson Culture Growth and/or Change The Clinician Understanding the Institution The Business of MD Anderson The MD Anderson Brand, Reputation Professional Practice The Professional at Work The Clinician at Work On Care Understanding Cancer, the History of Science, Cancer Research The History of Health Care, Patient Care
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.
Disciplines
History of Science, Technology, and Medicine | Oncology | Oral History
Transcript
Gabriel Hortobagyi, MD:
We need to share. We are a team. We need to share. We are a team. And repetition often serves to get a message eventually across. So that was that part. The research part was—research is always an evolving issue, and probably our very first research activities we did in breast medical oncology were the development of clinical trials. And we mentioned in one of our earlier conversations the combination of chemotherapy with the FAC regimen and the locally advanced and inflammatory breast cancer protocols. And then we got more and more into new drug development, so we started to do Phase II and Phase I clinical trials with new drugs. And that provided us with some resources because most of those drugs came from industry—pharmaceutical industry that had developed drug A, B, or C—and we would get access to that for doing a clinical trial, and the company would pay for the cost of doing that clinical trial. And you usually overestimate your costs a little bit so that you can be sure that the hospital doesn’t get shortchanged for that. And then sometimes there is a little bit of money left, and then you use that for reinvestment into research. And most of the costs of clinical trials are based on making sure that everything that the clinical trial calls for actually takes place and that all of the data are collected prospectively in the cleanest and most accurate fashion. For that you need research nurses, you need data managers, so much of the cost is related to personnel. And as the number of clinical trials we performed increased we had, of course, the need to have more and more personnel for that. So eventually we built out a group at the beginning—one and then two and then three—and eventually we got up to what we have now which is about fifteen or eighteen research nurses and about ten data managers and whatnot.
Tacey Ann Rosolowski, PhD:
Wow.
Gabriel Hortobagyi, MD:
And that allows you to then be a little bit more flexible about how you use those individuals and how you do that. In the meantime, of course, research became much more complex. The regulatory requirements became much more complicated. The actual complexity of the clinical trials became much more intense. Translational research became an integral part of clinical trials that required much more to do—additional biopsies, additional tests, additional imaging. So when we started, I remember the first nurse was able to handle eight, nine, sometimes ten different clinical trials at the same. Today one of my nurses can handle two trials at the same time. She’s a hero because it’s a much more labor-intensive effort and intensive activity. And then HIPAA came in of course, and many of the regulatory aspects of informed consent and how you manage the data and the external audits and the FDA audits. All of that was sort of each an added layer of activity on this.
Tacey Ann Rosolowski, PhD:
What’s your view of that? I’ve talked to people who have felt that regulations have gotten out of control. What’s your view of that? Are they a necessary burden? I mean—is it too burdensome?
Gabriel Hortobagyi, MD:
Well, on some of my worst days, I would like to be a dictator and go after the thirty or forty people around the country who are responsible because of their irresponsibility or malfeasance for the rest of us being punished with regulation. Because what has happened over the past forty years is that everything was going well, and then someone decides to be either sloppy or dishonest. And then in order to prevent that event from taking place again, there is a burden of regulation on everybody. And that has happened a number of times, so when you add up each individual—so each individual regulatory aspect may not be huge, but when you add twenty-five then the conglomerate of the twenty-five adds a huge amount of work, none of which actually improves the efficiency of research nor does it make delivery of effective treatment or diagnostic faster to the patient who is the only person important in this thing. And we do so many things to protect the bureaucracy that sometimes we forget why we do research, and it is a huge problem. It is a huge problem, but it is always the issue of the sins of the few end up punishing the many. So I don’t know where you stand on the gun controversy, but it’s not very different there, even though it’s both qualitatively and quantitatively a different controversy. But you get a mass murderer who takes an AR-15 or whatever that thing is called and goes out and kills twenty kids. Everybody in the country has to now think of gun control. Well, I happen to think that we do need some more strict rules, but in reality if nobody did that—if there were no mass murderers—we would not care that much about having 300 million or 400 million or 200 million guns in the country. Now unfortunately we have to care because these things keep on happening. And the same thing is in research—in medical research. Someone fakes a piece of research—everybody else pays. And we’ve been paying. We’ve been paying very heavily. When we started to run clinical trials we would get roughly a grant for—oh, the equivalent of maybe $400 or $500 per patient for running a Phase II clinical trial. Today it’s not unusual for a company to pay us—despite much more stringent review of the real cost—$25,000, $30,000 per patient. And when you talk to drug company folks when they have a new drug and they’re going to run the definitive clinical trial of whether the drug is or is not worth FDA approval, that company sets aside $200 million, $300 million for that single clinical trial. And much of that is to answer all the regulatory requirements.
Tacey Ann Rosolowski, PhD:
What do you think is the broader effect of that? When each clinical trial is so expensive, how does that change how research is done? I mean at the level of the institution.
Gabriel Hortobagyi, MD:
Well, it slows it down tremendously and requires—if we did today research and patient care the way we did it in 1973—so what is that? Forty years ago? We could probably do it with forty percent of the personnel we have on board today—maybe even less. So that gives you an idea of what the additional regulatory aspects of research and patient care and HIPAA and dealing with insurance companies and Medicare and Medicaid and whatnot has added to our ability to run an institution. It is a huge amount of extra—and in my mind—largely unnecessary cost. So Congress screams and yells about how expensive medical health care is. And we as private citizens see these costs escalating. But nobody thinks about how much of this is the effect of the laws passed by Congress and the regulations passed by government agencies and the doings of insurance companies. And of course it never ends because nobody takes ownership and nobody takes responsibility for this now. So it is—and even more than money the amount of time and effort of many of our brightest and best investigators that goes into these things that add no value to their research is a huge waste. Because instead of having—I don’t know—ten discoveries during their lifetime, they may have three or four because they have to spend so much time doing piddly stuff.
Tacey Ann Rosolowski, PhD:
I was reminded, too, when you were talking about those enormous costs, and I think in one of our previous conversations you talked about how the tendency for granting was actually—money is granted in a fairly conservative way, and I am sure those spiraling costs increase the conservatism as well.
Gabriel Hortobagyi, MD:
Absolutely.
Tacey Ann Rosolowski, PhD:
You don’t want to take risks—
Gabriel Hortobagyi, MD:
Absolutely.
Tacey Ann Rosolowski, PhD:
—when there is that much money at stake.
Gabriel Hortobagyi, MD:
Absolutely.
Tacey Ann Rosolowski, PhD:
Yeah. Now when you were and have been thinking about how to develop all of these elements of patient-centered care—the research, and we haven’t talked about education and the translational piece yet—but when you are thinking about all of that and how to get all the post pieces of the puzzle rising at the same time, did you—how long did it take you to understand how connected all of those things were in a program such as what is happening here at MD Anderson?
Gabriel Hortobagyi, MD:
I don’t know. I never thought of it in those terms.
Tacey Ann Rosolowski, PhD:
Or maybe you thought of it in a different way.
Gabriel Hortobagyi, MD:
The understanding of that develops gradually and develops in part because you look back at what you have done and what you have not done, and you look at the missing pieces and you say, “Gee, I should have done that, or I could have done that, or it’s time to do that.” And the other part of that is that as you become more clearly responsible from an administrative perspective to get many things done and developed, then you realize what it takes. Because while you are just thinking about doing your research, you think of what you need immediately to get that done. But you don’t necessarily think of what the optimal structure of a research infrastructure should be. All right? So as our research group was developing, well, I would discuss on a weekly basis or sometimes more often with my research nurses what our needs were, where we are short, where we were short of something, what more resources we needed to put in place, how could we be more efficient doing something. You think of different models of utilizing research personnel, and that’s what you do. And then as budgets become tighter, you really start to deconstruct the whole thing and start thinking about what other ways there are to build this out. So in that sense, that sort of underlies what we discussed earlier about the lack of the business orientation and training of physicians. And yes—what is that called? The executive development program—well, it was wonderful but that was a few weekends for a few months as opposed to a full MBA or as opposed to full training, as I’m going to be an executive in IBM or GM or Apple or something like that where you would from day one be used to thinking of this programmatically in the sense of I’m going to build the best and largest—I don’t know—racecar or the best and most efficient computer, and for that this is the way the business should look.
Tacey Ann Rosolowski, PhD:
Well, and I’m even thinking, too, that there’s an additional piece because you’re not just interested in creating the best and most impactful breast center. You want a breast center that’s going to be an engine of producing more knowledge about breast cancer.
Gabriel Hortobagyi, MD:
Absolutely.
Tacey Ann Rosolowski, PhD:
So there’s a strategic piece there, too.
Gabriel Hortobagyi, MD:
Well, and there’s the multitasking. Because if I’m the vice president for—I don’t know—new truck development at Ford, I focus on developing that new truck. And I’ve got some engineers working here and some marketing people and some people who are looking at cost and whatnot, but all of my focus is on that. Right? Here we have our focus on—we take care of a very large number of patients. And as a supervisor—as a department chair—I need to make sure that the quality of care is as high as can be, that all of my faculty members are providing the same or higher level of quality, that all of the support personnel—nurses and et cetera—are working in that direction, that my interactions as a department with the breast center—which is not directly under my control—is such that I can influence the development of the breast center. I am responsible for all of the research activities, making sure that the research productivity of the department is as high as can be and is the highest quality as it possibly can, making sure that the research enterprise breaks at least even and it doesn’t go in the red too often, making sure that I have the support research personnel that we need. I need to make sure that all of our research activities are actually coordinated and that there are no independent republics reinventing the wheel every so often. I need to make sure that each of my faculty members has a research activity so that their careers can be developed and that I can get them promoted, and I can get them rewarded for what they do. And I can hold them accountable for what they do. I need to make sure that we educate the next generation of physicians, that we mentor our younger faculty with the resources and knowledge of the older faculty, and that ultimately our entire budget as a department fits into the budget of the division and within the vice president—the line vice president of the institution. And during all of this I am writing papers, I am running my own research. I’m making presentations thirty, forty, fifty times a year around the globe; so the multitasking is quite considerable. You’re like the juggler—keeping as many of those objects in the air as you can.
Recommended Citation
Hortobagyi, Gabriel N. MD and Rosolowski, Tacey A. PhD, "Chapter 23: Regulations on Clinical Trials and New Research Projects in Breast Medical Oncology" (2013). Interview Chapters. 1128.
https://openworks.mdanderson.org/mchv_interviewchapters/1128
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