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
Adjuvant Radiation Therapy and Chemotherapy in Merkel Cell Carcinoma: Survival Analyses of 6908 Cases From the National Cancer Data Base.. Journal of the National Cancer Institute. 108(9). 2016.
Biomarker Panel for Chronic Graft-Versus-Host Disease.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology.. 2016.
Comorbidities, Alcohol Use Disorder, and Age Predict Outcomes Following Autologous Hematopoietic Cell Transplantation for Lymphoma.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2016.
Fluticasone, Azithromycin, and Montelukast Treatment for New-Onset Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 22(4):710-716.. 2016.
A randomized phase II crossover study of imatinib or rituximab for cutaneous sclerosis after hematopoietic cell transplantation.. Clinical cancer research : an official journal of the American Association for Cancer Research.. 2015.
Bandage soft contact lenses for ocular graft-versus-host disease.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 21(11):2002-7.. 2015.
Association of fludarabine pharmacokinetic/dynamic biomarkers with donor chimerism in nonmyeloablative HCT recipients.. Cancer chemotherapy and pharmacology.. 2015.
Autologous transplant for relapsed follicular lymphoma: impact of pre-transplant rituximab sensitivity.. Leukemia & lymphoma. 56(1):92-6.. 2015.
Long-term outcomes of patients with persistent indolent B cell malignancies undergoing nonmyeloablative allogeneic transplantation.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 21(2):281-7.. 2015.
Design and Validation of an Augmented Hematopoietic Cell Transplantation-Comorbidity Index Comprising Pretransplant Ferritin, Albumin, and Platelet Count for Prediction of Outcomes after Allogeneic Transplantation.. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.. 2015.
Gene therapy enhances chemotherapy tolerance and efficacy in glioblastoma patients.. The Journal of clinical investigation. 124(9):4082-92.. 2014.
Metabolic Syndrome Appears Early After Hematopoietic Cell Transplantation.. Metabolic syndrome and related disorders. 12(7):367-371.. 2014.
Comorbidity-age index: a clinical measure of biologic age before allogeneic hematopoietic cell transplantation.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 32(29):3249-56.. 2014.
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.
Plasma CXCL9 elevations correlate with chronic GVHD diagnosis.. Blood. 123(5):786-93.. 2014.