Barry E. Storer
Ph.D., University of Washington, Biostatistics, 1984.
M.A., University of Montana, Zoology, 1977.
B.A., University of New Hampshire, Zoology, 1973.
Biostatistical Methods And Applications In Clinical Trials And Epidemiology.
Although considerable attention has been paid to the design and analysis of Phase III clinical trials (randomized controlled trials of efficacy), relatively less effort has been directed to Phase II (uncontrolled trials of efficacy, often with surrogate endpoints) and especially Phase I (dose-finding trials evaluating toxicity) clinical trials. I have collaborated for many years with clinicians conducting Phase I clinical trials of anti-cancer agents, both traditional cytotoxic drugs and biological agents.
In typical designs for such studies, a starting dose level and a sequence of increasing dose levels thereafter are determined based on the results of toxicity trials in animals. Small cohorts of patients (3-6 per dose level) are entered beginning at the first dose level. Subsequent cohorts are entered either at the next higher dose level, or the trial is stopped, depending on the toxicity experience in the current cohort, according to a predetermined algorithm.
One of my research interests has been to evaluate the operating characteristics of designs of this type and to consider designs that differ from the standard. The operating characteristics of a design unfortunately depend to a large extent on the true dose-toxicity curve, which is unknown; however, Monte Carlo simulations conducted over a wide range of plausible dose-response settings can provide useful information regarding the performance of the design and enable a clinician to choose a particular design based on objective characteristics.
Here at the Fred Hutchinson Cancer Research Center, some Phase I trials in the stem cell transplant program can be designed to address dose-finding with respect to both toxicity and efficacy in the same patient population. For example, a drug used to prevent graft versus host disease (GVHD) may be more effective at a higher dose but also have greater toxicity, and the goal is to find a dose that achieves a desirable combination of efficacy and safety. The design of such trials is of interest to myself and other statisticians in the Clinical Research Division.
Other methodologic work has focused on the design of Phase II trials, as well as diagnostics for identifying unusually influential observations in regression analysis.
American Statistical Association
Society for Clinical Trials
1992-1995, Associate Professor, University of Wisconsin, Statistics, Biostatistics
1990-1992, Associate Professor, University of Wisconsin, Statistics, Human Oncology
1984-1995, Member, University of Wisconsin, Comprehensive Cancer Center
1984-1990, Assistant Professor, University of Wisconsin, Statistics, Human Oncology
1981-1983, Research Associate, Fred Hutchinson Cancer Research Center, National Wilms Tumor Study
1979-1981, Research Associate, University of Washington, School of Public Health and Community Medicine, Biostatistics
-1984, Assistant Staff Scientist, Fred Hutchinson Cancer Research Center, Public Health Sciences
Recipient Pretransplant Inosine Monophosphate Dehydrogenase Activity In Nonmyeloablative Hct.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2014.
Metabolic Syndrome Appears Early After Hematopoietic Cell Transplantation.. Metabolic syndrome and related disorders.. 2014.
Plasma CXCL9 elevations correlate with chronic GVHD diagnosis.. Blood. 123(5):786-93.. 2014.
Application of CIBMTR risk score to NIH chronic GVHD at individual centers.. Blood. 123(3):453-5.. 2014.
Treosulfan, Fludarabine, and 2-Gy Total Body Irradiation Followed by Allogeneic Hematopoietic Cell Transplantation in Patients with Myelodysplastic Syndrome and Acute Myeloid Leukemia.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2014.
Relationships among primary tumor size, number of involved nodes, and survival for 8044 cases of Merkel cell carcinoma.. Journal of the American Academy of Dermatology.. 2014.
Gallstones in Pediatric Hematopoietic Cell Transplant Survivors With Up to 40 Years of Follow-up.. Journal of pediatric hematology/oncology. 36(6):484-490.. 2014.
Pharmacokinetic and Pharmacodynamic Analysis of Inosine Monophosphate Dehydrogenase (Impdh) Activity in Mmf-Treated Hct Recipients.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2014.
Nephrolithiasis in pediatric hematopoietic cell transplantation with up to 40 years of follow-up.. Pediatric blood & cancer.. 2013.
A Novel Soluble Form of Tim-3 Associated with Severe Graft-versus-Host Disease.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2013.
Fludarabine and 2-Gy TBI is Superior to 2 Gy TBI as Conditioning for HLA-Matched Related Hematopoietic Cell Transplantation: A Phase III Randomized Trial.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2013.
Cyclophosphamide followed by intravenous targeted busulfan for allogeneic hematopoietic cell transplantation: pharmacokinetics and clinical outcomes.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 19(7):1033-9.. 2013.
Allogeneic Hematopoietic Cell Transplantation Following Minimal Intensity Conditioning: Predicting Acute Graft-versus-Host Disease and Graft-versus-Tumor Effects.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2013.
p63 expression in Merkel cell carcinoma predicts poorer survival yet may have limited clinical utility.. American journal of clinical pathology. 140(6):838-44.. 2013.