Theodore Karrison, PhD


  • B.S. (Mathematics & Computer Science), University of Illinois at Chicago, 1970-74
  • M.S. (Statistics), University of Chicago, 1974-75
  • Ph.D. (Statistics) University of Chicago, 1985


Dr. Karrison’s research interests have focused on the design and analysis of clinical trials, as well as participation in collaborative research across a broad spectrum of diseases. He has participated in the conduct and analysis of several multicenter, randomized clinical trials, including the Persantine-Aspirin Reinfarction Study (PARIS), PARIS II, the International Mexilitine and Placebo Antiarrhythmic Coronary Trial (IMPACT), the Recurrent Miscarriage Study (REMIS) and, more recently, the Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer trial (DeCIDE). He worked on the development of methods for estimating the secretion rate of insulin and C-peptide in normal and diabetic patients, a retrospective study of the utility of measures for differentiating ruptured and unruptured aneurysms, and an observational study of long-term outcomes in women with breast cancer. In 1996 he transferred to the Department of Health Studies (now Department of Public Health Sciences) and in 1997 was appointed Director of the Biostatistics Laboratory, a core facility that provides statistical support for study design and data analysis to investigators within the Biological Sciences Division. He also serves as technical director of the Biostatistics Core for the University of Chicago Comprehensive Cancer Center. Dr. Karrison’s statistical methodological research interests include survival analysis, in particular the estimation and comparison of restricted mean and median survival times, methods for multiple endpoints and the selection of endpoints for phase II oncology trials, and response-adaptive designs. His ongoing NIH-funded and other major research projects include:

  • Cancer Center Support Grant: The overall goal of the University of Chicago Comprehensive Cancer Center (UCCCC) is to discover and translate new cancer-specific knowledge to prevent, detect, and treat cancer. The Biostatistics Core Facility, under the direction of Drs. Ronald Thisted and Theodore Karrison, provides collaborative support to UCCCC investigators in the design and statistical analysis of clinical trials, observational studies, and basic science experiments.
  • Clinical Translational Science Award (CTSA): The goal of the Institute for Translational Medicine (ITM), funded by the CTSA, is to create an integrated program designed to leverage expertise in high throughput technologies, novel phenotype- and grid accessible- bioinformatics, health disparities research, clinical trials, and medical ethics in order to rapidly translate biomedical discovery into personalized therapies. Dr. Karrison, as leader of the Population Sciences Cluster Area, supervises a group of statisticians who provide biostatistics, epidemiology, and research design support for ITM investigators.
  • Phase I Clinical Trials of Anticancer Agents: The major goal of this NCI Cooperative Agreement is to conduct phase I studies for determination of pharmacokinetics, safety, and maximum tolerated dose of new anticancer drugs. As co-investigator, Dr. Karrison collaborates on study design and analysis of phase I trials, including sample size and power calculations, data analysis, and manuscript preparation.
  • Early Therapeutics Development with Phase II Emphasis: Dr. Karrison collaborates on the design and statistical analysis of randomized and single-arm phase II clinical trials of NCI-sponsored agents conducted within the UCCCC Phase II Consortium. The consortium is composed of academic sites and community based institutions that evaluate the anti-tumor activity, safety, pharmacokinetics, and pharmacodynamic effects of selected chemotherapeutic, immunologic, and radiologic agents and treatment combinations. Dr. Karrison participates in the submission of letters of intent, the writing of statistical sections for new protocols, randomization, interim and final statistical analyses, and the development of manuscripts for publication.
  • Household Air Pollution for Burning Biomass: Implications for Maternal Health and Pregnancy Outcomes: Dr. Karrison is co-investigator and lead statistician for this project, which is a randomized comparison of the effects of ethanol stoves versus wood-burning and kerosene stoves on health outcomes of pregnant women and their offspring in Ibadan, Nigeria. The overall hypothesis is that ethanol stoves will reduce pregnant women’s exposures to indoor pollutants and thereby reduce adverse pregnancy outcomes.
  • Validating Metformin as a Novel Agent for Ovarian Cancer Treatment: This study is a randomized phase II clinical trial of chemotherapy plus metformin versus chemotherapy alone in women with stage III/IV ovarian cancer. As co-investigator, Dr. Karrison has collaborated on the design of the trial, including sample size and power calculations, developed the statistical analysis plan, established randomization procedures, and will provide interim and final statistical analyses for internal reports and publication of results.
  • Versatile Tests for Comparing Survival Curves based on Weighted Logrank Statistics: The logrank test is perhaps the most commonly used nonparametric method for comparing survival curves, yielding maximum power under proportional hazards alternatives. Although proportional hazards is often a reasonable assumption, it need not hold, and several authors have developed more versatile tests using combinations of weighted log-rank statistics based on the G(rho,gamma) family. Dr. Karrison is exploring the use of Zm=max(|Z1|, |Z2|, |Z3|), where Z1, Z2, and Z3 are z-statistics obtained from G(0,0), G(1,0), and G(0,1) tests, respectively. G(0,0) corresponds to the logrank test while G(1,0) and G(0,1) are more sensitive to early and late difference alternatives. Simulation studies under proportional hazards, early difference, and late difference alternatives are being conducted as well as development of a STATA (College Station, TX) program for public use.


    • Karrison, T. (1981). Data editing in a clinical trial. Controlled Clinical Trials, 2(1):15-29.
    • Polonsky, K.S., Pugh, W., Jaspan, J.B., Cohen, D.M., Karrison, T., Tager, H.S., and Rubenstein, A.H. (1984). C-peptide and insulin secretion. Relationship between peripheral concentrations of C-peptide and insulin and their secretion rates in the dog. J. Clin. Invest., 74:1821-1829. PMCID: PMC425632
    • Meier, P, Ferguson, D.F., and Karrison, T. (1985). A controlled trial of extended radical mastectomy. Cancer, 55:198-209.
    • Alamercery, Y., Wilkins, P., and Karrison, T. (1986). Functional equality of coordinating centers in a multicenter clinical trial: experience of the International Mexiletine and Placebo Antiarrhythmic Coronary Trial. Controlled Clinical Trials, 7(1):38-52.
    • Karrison, T. (1987). Restricted mean life with adjustment for covariates. Journal of the American Statistical Assn., 82(400):1169-1176.
    • Karrison, T. (1990). Bootstrapping censored data with covariates. Journal of Statistical Computation and Simulation, 36:195-207
    • Karrison, T. (1995). Comparison of median survival times with adjustment for covariates. Statistics in Medicine, 14(23):2537-2553.
    • Karrison, T. (1996). Confidence intervals for median survival times under a piecewise exponential model with proportional hazards covariate effects, Statistics in Medicine, 15(2):171-182.
    • Karrison, T. (1997). Use of Irwin's restricted mean as an index for comparing survival in different treatment groups -- Interpretation and power considerations, Controlled Clinical Trials, 18:151-167.
    • Karrison, T. and Ober, C. (1998). Recurrent Miscarriage (REMIS) Study: How should data from women who do not become pregnant be handled? Controlled Clinical Trials 19:430-439.
    • Karrison, T.G., Ferguson, D.J., and Meier, P. (1999). Dormancy of mammary carcinoma after mastectomy, Journal of the National Cancer Institute 91(1):80-85.
    • Hollingsworth, K.L., Zimmerman, T.M., Karrison, T., Oliver, A., and Williams, S.F. (1999). The CD34+ cell concentration in peripheral blood predicts CD34+ cell yield in the leukapheresis product, Cytotherapy 1:141-146.
    • Ober, C.O., Karrison, T., Odem, R.R., Barnes, R.B., Branch, D. W., Stephenson, M.D., Baron, B, Walker, M.A., Scott, J.R., and Schreiber, J.R. (1999). The Recurrent Miscarriage (REMIS) Study: Mononuclear cell immunisation in prevention of recurrent miscarriages: a randomised trial, Lancet 354:365-369.
    • Karrison TG, Huo D, and Chappell R (2003). A group sequential, response-adaptive design for randomized clinical trials, Controlled Clinical Trials 24:506-522.
    • Weir B, Amidei C, Kongable G, Findlay JM, Kassell NF, Kelly J, Dai L, and Karrison TG (2003). The aspect ratio (dome/neck) of ruptured and unruptured aneurysms, J Neurosurg 99:447-451.
    • Karrison TG and O’Brien PC (2004). A rank-sum-type test for paired data with multiple endpoints, Journal of Applied Statistics 31:229-238.
    • Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, Karrison T, Janisch L, Ramirez J, Rudin CM, Vokes EE, and Ratain MJ (2004). Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan, J Clin Oncology 22:1382-1388.
    • Meier P, Karrison T, Chappell R, Xie H (2004). The price of Kaplan-Meier, J. Am. Stat. Assoc., Journal American Statistical Assn 99: 890-896.
    • Karrison TG, Maitland ML, Stadler WM, Ratain MJ (2007). Design of phase II cancer trials using a continuous endpoint of change in tumor size: Application to a study of sorafenib and erlotinib in non-small-cell lung cancer, JNCI 99:1456-1461.
    • Kocherginsky M, Cohen EEW, Karrison T (2009). Design of phase II cancer trials for evaluation of cytostatic/cytotoxic agents, Journal of Biopharmaceutical Statistics 19:524-529.
    • Cohen EEW, Subramanian J, Gao F, Szeto L, Kozloff M, Faoro L, Karrison T, Salgia R, Govindan R, Vokes EE (2011). Targeted and cytotoxic therapy in coordinated sequence (TACTICS): Erlotinib, bevacizumab, and standard chemotherapy for non-small-cell lung cancer, a phase II trial. Clinical Lung Cancer, available online 18 November, 2011. >
    • Chung EK, Posadas EM, Kasza K, Karrison T, Manchen E, Hahn OM, Stadler W (2011). A phase II trial of gemcitabine, capecitabine, and bevacizumab in metastatic renal carcinoma. Am J Clin Oncology. Am J Clin Oncology 34:150-154.
    • McLeod R, Boyer KM, Lee D, Mui E, Wroblewski K, Karrison T, Noble AG, Withers S, Swisher CN, Hydemann PT, Sautter M, Babiarz J, Rabiah P, Meier P, Grigg ME, the Toxoplasmosis Study Group (2012). Prematurity and severity are associated with toxoplasma gondii alleles (NCCCTS, 1981-2009). Clin Infect Dis 54:1595-1605. PMCID: PMC3348955
    • Kindler HL, Karrison TG, Gandara DR, Lu C, Krug LM, Stevenson JP, et al. (2012). Multicenter, double-blind, placebo-controlled, randomized phase II trial of gemcitabine/cisplatin plus bevacizumab or placebo in patients with malignant mesothelioma. Journal Clin Oncology 30:2509-2515. PMCID: PMC3397785
    • Sharma MR, Karrison TG, Jin Y, Bies RR, Maitland MM, Stadler WM, Ratain MJ (2012). Resampling phase III data to assess phase II trial designs and endpoints. Clin Cancer Research 18:2309-2315. PMCID: PMC3328614
    • Karrison TG, Ratain MJ, Stadler WM, Rosner GL (2012). Estimation of progression-free survival for all treated patients in the randomized discontinuation trial design. The American Statistician 66:155-162. PMCID: PMC3328614
    • Maitland ML, Wu K, Sharma MR, Jin Y, Kang SP, Stadler WM, Karrison TG, Ratian MJ, Bies RR (2013). Estimation of renal cell carcinoma treatment effects from disease progression modeling. Clinical Pharmacology & Therapeutics 93:345-351. PMCID: PMC3791430
    • Sharma MR, Karrison TG, Kell B, Wu K, Turcich M, Geary D, Kang SP, Takebe N, Graham RA, Maitland ML, Schilsky RL, Ratain MJ, Cohen EEW (2013). Evaluation of food effect on pharmacokinetics of vismodegib in advance solid tumor patients. Clinical Cancer Research, OnlineFirst April 3, 2013. PMCID: PMC3674138
    • Bhatta SS, Wroblewski KE, Agarwal KL, Sit L, Cohen EEW, Seiwert TY, Karrison T, Bakris GL, Ratain MJ, Vokes EE, Maitland ML (2013). Effects of vascular endothelial growth factor signaling inhibition on human erythropoiesis. The Oncologist 18:965-970. PMCID:
    • Gerard DP, Foster DB, Raiser MW, Holden JL, Karrison, TG (2013). Validation of a new bowel preparation scale for measuring colon cleansing for colonoscopy: The Chicago bowel preparation scale. Clinical and Translational Gastroenterology 4, e43.
    • Churpek JE, Pro B, van Besien K, Kline J, Conner K, Wade JL III, Hagemeister F, Karrison T, Smith SM (2013). A phase 2 study of epothilone B analog BMS-247550 (NSC 710428) in patients with relapsed aggressive non-Hodgkin lymphomas. Cancer 119(9):1683-1689.
    • Prasad SM, Large MC, Patel AR, Famakinwa O, Galocy RM, Karrison T, Shalhav AL, Zagaja GP (2014). Randomized, controlled Trial of early removal of urethral catheter with suprapubic tube drainage versus urethral catheter dainage alone following robot-assisted laparoscopic radical prostatectomy. The Journal of Urology 192:1-8.
    • Cohen EEW, Karrison TG, Kocherginsky M, Mueller J, Egan R, Huang CH, et al. (2014).  Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer.  Journal of Clinical Oncology 32(25):2735-2743.
    • Sharma MR, Gray E, Goldberg RM, Sargent DJ, Karrison TG (2014).  Resampling the N9741 trial to compare tumor dynamic versus conventional end points in randomized phase II trials.  Journal of Clinical Oncology, published ahead of print on October 27, 2014.