Thomas D. Cook

Design and analysis of clinical trials, Bayesian applications in biostatistics.

Details: A primary area of interest is the design, monitoring and analysis of controlled clinical trials. Specific interests include methods for adjusting sample sizes/recruitment rates in order to maintain study power as trials unfold and interim data becomes available. I have written an made available software which to facilitate such decisions for trials with survival endpoints. Another issue in the interim monitoring of clinical trials with survival endpoints is incompleteness of interim data, specifically those attributed to delays in reporting potential primary events as well as to delays in the adjudication of reported events. I have developed methods for accounting for delays in adjudication and am working in combine these methods with techniques which account for reporting delays.

Another specific interest is the production of data monitoring reports. Data monitoring reports must be produced in a timely fashion, often with large numbers of variables which must be presented in various formats. Furthermore, data monitoring committees must be able to digest the information presented quickly and accurately in order to make timely decisions regarding the conduct of the trial. The most efficient mode of presentation is usually graphical and computer software has been created to efficiently analyze large amounts of accumulating data and create useful reports.

Cook, Thomas; Benner, Rebecca and Fisher, Marian, The WIZARD Trial as a Case Study of Flexible Clinical Trial Design. Drug Information Journal, 40:345-353, 2006

Aguilar, David; Fisher, Marian; O'Connor, Christopher; Dunne, Michael; Muhlestein, Joseph; Yao, Louis; Gupta, Sandeep; Benner, Rebecca; Cook, Thomas; Edwards, Dearborn and Pfeffer, Marc. Metabolic Syndrome, C-Reactive Protein, and Prognosis in Patients with Established Coronary Artery Disease. American Heart Journal 152(2):298-304, 2006

Newman, George; Hospod, Frank; Patlak, Clifford; Fain, Sean; Pulfer, Kari; Cook, Thomas and O'Sullivan, Finbarr. Experimental estimates of the constants relating signal change to contrast concentration for cerebral blood volume by T2*MRI. Journal of Cerebral Blood Flow & Metabolism 26(6):760-70, 2006

Moftakhar, Roham; Turk, Aquilla; Niemann, David; Hussain, Sayed; Rajpal, Sharad; Cook, Thomas; Geraghty, Madeleine; Aagaard-Kienitz, Beverly; Turski, Patrick and Newman, George. Effects of Carotid or Vertebrobasilar Stent Placement on Cerebral Perfusion and Cognition. Am J Neuroradiol, 26:1772-1780, 2005

Getz Kelly, Kiesa; Cook, Thomas and Backonja, Misha-Miroslav. Pain Ratings at the Thresholds are Necessary for Interpretation of Quantitative Sensory Testing. Muscle and Nerve, 32(2):179-184, 2005

Cook, Thomas D. and Kosorok, Michael R. Analysis of Time-to-event Data with Incomplete Event Adjudication. JASA, 99(468):1140-1152, 2004

Iskandar, Bermans. J.; Nelson, Aaron; Resnick, Daniel; Skene, J. H. Pate; Gao, Peng; Johnson, Chenara; Cook, Thomas and Hariharan, Nithya. Folic Acid Supplementation Enhances Repair of the Adult Central Nervous System. Annals of Neurology, 56(2):221-227, 2004

Cook, Thomas. D., Methods for Mid-course Corrections for Clinical Trials with Survival Outcomes, Statistics in Medicine,, 22:22, 3431-3447, 2003

O'Connor, Christopher M.; Dunne, Michael W.; Pfeffer, Marc A., Muhlestein; Joseph B.; Yao, Louis; Gupta, Sandeep; Benner, Rebecca J.; Fisher, Marian R.; and Cook, Thomas D., A double-blind, randomized, placebo controlled trial of azithromycin for the secondary prevention of coronary heart disease: the WIZARD Trial, JAMA, 290:11, 1459-1466, 2003

Cook, T. D., P-value adjustment in sequential clinical trials. Biometrics, 58(4):1005-11, 2002

Cook, T. D., Up with odds-ratios! A case for odds ratios when outcomes are common. Academic Emergency Medicine, 9(12):1430-34, 2002

Lewis, Roger J.; Berry, Donald A.; Cryer, Henry III; Fost, Norman; Krome, Ronald; Washington, Geraldine R.; Houghton, Jaime; Blue, John W.; Bechhofer, Robin; Cook, Thomas and Fisher, Marian, Monitoring a Clinical Trial Conducted Under the FDA Regulations Allowing a Waiver of Prospective Informed Consent: The DCLHb Traumatic Hemorrhagic Shock Efficacy Trial. Annals of Emergency Medicine, 38:4, 397-404, 2001

Cook, T. D., Adjusting Survival Analysis for the Presence of Unadjudicated Study Events. Controlled Clincal Trials, 21(3):208-222, 2000

Edward P. Sloan; Max Koenigsberg; David Gens; Mark Cipolle; Jeffrey Runge; Mary Nan Mallory; George Rodman, Jr; for the DCLHb Traumatic Hemorrhagic Shock Study Group, Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Severe Traumatic Hemorrhagic Shock A Randomized Controlled Efficacy Trial. JAMA, 282(19):1857-1864, 1999

Cook, T. D., Clayton, M. K. Sequential Bayesian Quadrature. Technical Report 993, Department of Statistics, University of Wisconsin--Madison, 1998

Wenzl TB, Riehmann M, Cook TD, Bruskewitz RC. Variation in PSA values in patients without malignancy. Urology 52(5):932, 1998 (Nov.)

Mentzer RM Jr, Rahko PS, Molina-Viamonte V, Canver CC, Chopra PS, Love RB, Cook TD, Hegge JO, Lasley RD. Safety, tolerance, and efficacy of adenosine as an additive to blood cardioplegia in humans during coronary artery bypass surgery. American Journal of Cardiology 79(12A):38-43, 1997 (Jun 19).

ACTS Study Group: A double--blind placebo--controlled clinical trial of subcutaneous recombinant human ciliary neurotrophic factor (rHCNTF) in amyotrophic lateral sclerosis. Neurology, 232:5, 1244--9, 1996

The National Isometric Muscle Strength (NIMS) Database Consortium, Muscular Weakness Assessment: Use of Normal Isometric Strength Data. Arch Phys Med Rehabil, 77:1251-1255, 1996

Mentzer RM, Rahko PS, Canver CC, Chopra PS, Love RB, Cook TD, Hegge JO, Lasley RD. "Adenosine reduces postbypass transfusion requirements in humans after heart surgery." Annals of Surgery 224(4):523-530, 1996.

Sanjak M, Belden D, Cook T, Brooks BR. "Muscle strength measurement" in Lane RJM (ed.) Handbook of Muscle Disease. New York: Marcel Dekker, p. 19-34, 1996

Damron TA, Breed AL, Cook TD: "Diminished knee flexion after hamstring surgery in cerebral palsy patients: prevalence and severity." Journal of Pediatric Orthopaedics 13(2):188-191, 1993 (Mar).

Riehmann M, Rhodes PR, Cook TD, Grose GS, Bruskewitz, RC: "Analysis of variation in prostate-specific antigen values." Urology 42:4, 1993.

Cook DA, Breed AL, Cook TD, DeSmet AD, Muehle CM: "Observer variability in the radiographic measurement and classification of metatarsus adductus." Journal of Pediatric Orthopaedics, 12:86-89, 1992.

Palta M, Cook TD: "Some considerations in the analysis of rates of change in longitudinal studies." Statistics in Medicine 6:599-611, 1987.

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Spring 1996, 1997, 1998 - Statistics 642 (Statistical Methods for Epidemiology)

Fall 1996 - Statistics 641 (Statistical Methods for Clinical Trials)

Spring 2000 - Preventive Medicine 800 (Statistics in Epidemiology)