Research > Statisticians' Forum
Statisticians’ Forum is a feature designed to give biostatisticians who work on oncology clinical trials an opportunity to share their experience and insights with others in a question and answer interview format. David Gray, PhD, CRAB Board Member, and Antje Hoering, PhD, President and CEO, founded the Statisticians’ Forum to highlight the important role that statistics play in oncology research. Their goal is to publish two to four interviews each year, focusing on the biostatisticians who design, manage and analyze oncology clinical trials. Clinical trials are still the tool of choice to understand and validate new therapies and the unprecedented pace at which new cancer studies are being initiated confirms their continuing importance.
Interview with Tomi Mori, PhD, MBA
Director, Biostatistics Shared Resource
Professor, OHSU School of Medicine and OHSU School of Public Health
Current Position: Walter & Clora Brownfield Professor of Cancer Biostatistics, Director, Biostatistics Shared Resource, Knight Cancer Institute; Professor of Biostatistics, Oregon Health & Science University – Portland State University School of Public Health; Department of Medical Informatics and Clinical Epidemiology, School of Medicine, Oregon Health & Science University
I was born in Hakodate, Japan. My home town is a mid-sized town by the sea at the southern tip of the northern island.
By J oFg2MisiaseHosomallmonta (Flickr)Composition by Kyoww - File:Goryokaku fort retouched 20060814-001.jpgFile:HakodateChurchFrontView.jpgFile:Play of fireworks and night scenes in Hakodate.jpgFile:Gtwintower.JPGFile:Hakodate 1.jpg, CC BY-SA 2.0, Link
We should pay greater attentions to Big Data including data science, bioinformatics, computational biology and systems biology. Sometimes it’s challenging to work with all these groups but we once we come together it’s about trying to create teamwork. They have a different role and different ways they can contribute. Conflict happens when people feel "this is my area", but if you have common goals in mind to advance science we all can help each other to get there. In cancer research I feel we have to work as a team because it’s complex.
If you want to go into biomedical research you have to love the biology. You have to be interested in research and be passionate about the area of research. And try to understand what the other groups and disciplines are trying to do. That goes along with being part of the team. Be open minded about the different perspectives; not just that you’re right and they’re wrong. See how different people view the problem. For example an economist will look at the problem very differently and use different language but you find out we are really talking about the same thing. You have to be patient and not rush to judgement.
My role as the Director of the Biostatistics Shared Resource has not changed over the last 10 years. We are excited with the growth of the unit and a new partnership with the Cancer Research and Biostatistics (CRAB). We are using less and less 3+3 design for the Phase I trial, which has taken a long time. I see more and more of biomarker driven trials and combination trials. We are using more Bayesian type Phase I designs but sometimes it’s hard to get buy in from the investigator or pharmaceutical companies who say they want 3+3. So we are spending a lot of time educating the investigators. Changing the culture and mindset is hard. Fellows and junior investigators seem willing to do it but the mentor who may be a senior investigator often says, “Why don’t you do it the other way?” The sample size in the Bayesian design is bigger but you get better information this way. This increases the cost of the trial so there’s a little more convincing to do but we are getting there. We also have a number of precision medicine studies where people are assigned different drugs based on a molecular profile. The sample size per drug group gets really small. The studies are becoming more descriptive in a way and people have to use more modelling.
All studies at Knight go through scientific review. We have three biostatisticians involved in scientific review. They will comment that there are better designs than 3+3 but we really can’t force an industry sponsor to change its study design. But if it’s an industry sponsored investigator initiated trial we do have a say. If the investigator wants to do a 3+3 we can come back with a proposal for a better design. If we can convince the investigator and as long as they meet the budget we can probably get buy in. The part that is really hard in working with industry are the precision medicine trials which use drugs from different companies in the same trial. We have to go to the different companies to get buy in for the study and it can be really difficult.
I expect more and more adaptive trials, Bayesian methodologies, biomarker driven trials, immunotherapy, and combination trials. I expect that we will be more involved in “data” capture, evaluation and sharing of not only clinical data, but also “omics” and imaging data. A couple of years ago we rolled out an EDC system for clinical trials. The database builder took the protocol and built the database based on the protocol. Then we were asked to review the database and sign off on it. What we realized was the protocol was not written precise enough for the database builder to build the database. For example one protocol stated the primary objective is treatment response but there was no description of what the treatment response was or what time point it was. The statistician reviewing the protocol, because we had been asked to sign off on the database, looked at the schedule for assessing treatment response. One of the criteria was imaging. She looked at the imaging schedule and it didn’t line up with the treatment assessments.
Prior to EDC we hadn’t done this type of review. All we did was write the statistics section and really didn’t look at the rest of the protocol except for the endpoint definitions. But we hadn’t looked at a protocol in a way that someone would build a database. The way we look at the protocol, the data, and the way we interface with the EDC system is all new. Then we started asking all these questions of the study team and they got annoyed with us. Now the whole dynamic of our interactions with the PI, the study team and the clinical informatics team has changed. We are all trying to learn from one another to make things go smoothly. The time when we just got the data, analyzed it, sent it back, and were done, that time is gone.