Chapter 20: Adding Biostatistician to Research Protocols Raises the Bar of MD Anderson Research
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Description
In this chapter, Dr. Elting explains how it became a requirement to include a biostatistician to all MD Anderson research protocols. When Dr. Don Berry was recruited to head the Department of Biostatistics, this new requirement was a condition for accepting the position.
Dr. Elting agreed with his requirement and talks about its significance. She explains how important a biostatistician’s view can be in designing and protocol as well as interpreting data. (She comments on the design of research conducted by pharmaceutical companies.) She talks about the positive effect on MD Anderson research.
Dr. Elting observes that PIs were at first skeptical, because they didn’t know how they would pay for biostatistics services, but Don Berry secured substantial funds from MD Anderson to provide this support free of charge and most people were happy to have the help.
Identifier
EltingL_04_20150423_C20
Publication Date
4-23-2015
City
Houston, Texas
Interview Session
Linda S. Elting, DrPh, Oral History Interview, April 23, 2015
Topics Covered
The University of Texas MD Anderson Cancer Center - Institutional Processes; Institutional Processes; MD Anderson Culture; Research, Care, and Education
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
Tacey A. Rosolowski, PhD:
I wanted to also ask you a related question. Or it seems related to me. You can tell me about timing of this. There was a period at MD Anderson when all protocols had to have a biostatistician as part of it. And I was wondering when about that happened, when that became a requirement.
Linda S. Elting, DrPh:
When Don Berry walked in the door. (laughter)
Tacey A. Rosolowski, PhD:
About what year was that?
Linda S. Elting, DrPh:
I don't know. I guess late "˜90s. He was recruited to be head of Biostatistics. He's an internationally renowned biostatistician. And it was a real coup to bring him here to lead that department because he was so famous. And one of the things we all understood was part of his agreement with the people who hired him was that biostatisticians were going to be a part of all of the studies, and that the bar of statistical analysis at MD Anderson was going to be raised. And he I think asked for enough people who were paid by the institution so that every protocol could have a statistician even if they couldn't afford to defray the salary for one. And it was
Tacey A. Rosolowski, PhD:
Now just so it's absolutely clear, why did he insist on that? Why was that such an important thing to make happen at MD Anderson?
Linda S. Elting, DrPh:
Well, I think because there's so much of the medical literature where huge amounts of money have been spent to do a study and the results are really not conclusive because the statistical plan or the analysis that was done was inadequate. And the other piece of that was that the statistical analysis, if it was supplied as part of a study that was being sponsored by a pharmaceutical company, would have been planned by the pharmaceutical company. And I believe there are those who perceive that as a conflict of interest, even though typically it wasn't. I think it's pretty rare to find a company that was trying to skew the results through the statistical plan. It's not at all unusual to find analyses that are skewed on the back end where they're doing the analysis and reporting. But I think the goal was to raise the science to a point where we're doing important studies that have an impact on care because they were planned right, conducted right, and reported right. And I think Don was one of those people who was creating innovations in design, in how things were designed, in how things were analyzed. And because he was so focused on that, he was also really focused on things that we were doing because we'd been doing them that way for ten decades and they really weren't turning out the kind of results we could use. There were better ways to do things. And I think he came to MD Anderson because we do so many more studies than anybody else. And if he could implement his way of doing things, he could have a big impact on how science was done in cancer.
Tacey A. Rosolowski, PhD:
So what was your part in all of this when he came? How were you involved in changing all that?
Linda S. Elting, DrPh:
I wasn't really. I was in the department as I told you because I had to find a department for us to be in.
Tacey A. Rosolowski, PhD:
So what was your reaction when you heard that this was going to be the new way of operating?
Linda S. Elting, DrPh:
Well, I agreed with it as soon as I heard it. My only concernas a faculty member, when I first heard this, I thought oh no, what if I'm doing a study where I can't afford a statistician. It's already started and I don't have it budgeted. Or I'm doing it with the leftover funds from something else, and I'll never be able to afford a statistician for every study. So I was a little anxious about that, and lots of people were. But I think when it became clear that you walk up to the door and you ask them for help and they give you help whether you have money or not was really attractive. And while there was some disagreement up front, once people started doing that and knocking on the door, they discovered that they could actually turn over that whole section of the protocol, and that whole section of the grant, to that department. And it came out and it would improve your score with the grant reviewers. And it made things easier. Now it did mean that there was another week added in to get those answers back. And there were people who did research in the fast lane who were really experienced who could write those statistical sections themselves quickly who were slowed down because that happened. But that was the minority of people. Most people I think were delighted to have the help. And the only problem it really meant for most people was in slowing the process just a little bit. Because most of the protocol had to be done before the statistician could look at it and write it and determine that. But I think it was a wonderful change. I think it cost the institution a bundle of money initially to create all those new positions for statisticians and start providing that as a service to faculty in the institution, whereas before it was just a few statisticians in the department, and if you didn't have grant money to support their salary, then they didn't work with you. So that was a huge commitment on the part of the institution but I think it was worth every penny.
Tacey A. Rosolowski, PhD:
And obviously it's still in place.
Linda S. Elting, DrPh:
Oh yes.
Tacey A. Rosolowski, PhD:
And is it growing now? It seems like with big data and
Linda S. Elting, DrPh:
I think it's not so much growing as it is realigning. I think the core people who do statistical designs for clinical trials is not so much growing as the people who are also doing the big data or doing bioinformatics or genomics and that sort of thing. So statisticians with different kind of specialties are increasing in number very rapidly.
Tacey A. Rosolowski, PhD:
Interesting. I was out of questions in this topic area with your work on the IRBs, other administrative things. Was there anything that I've missed in that area? Some contributions you've made that we haven't covered?
Linda S. Elting, DrPh:
I don't think so.
Recommended Citation
Elting, Linda E. DPh and Rosolowski, Tacey A. PhD, "Chapter 20: Adding Biostatistician to Research Protocols Raises the Bar of MD Anderson Research" (2015). Interview Chapters. 724.
https://openworks.mdanderson.org/mchv_interviewchapters/724
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