Statistical publications

• Thall PF, Lee S-J. Practical model-based dose-finding in phase I clinical trials. Methods based on toxicity. International Journal of Gynecological Cancer. (In press, 2003).

• Estey EH, Thall PF. New designs for phase II clinical trials. Blood. (In press, 2003).

• Cheung YK, Thall PF. Monitoring the rates of composite events with censored data in phase II clinical trials. Biometrics 2002; 58(1):89-97.

• Thall PF, Sung H-G, Estey EH. Selecting therapeutic strategies based on efficacy and death in multi-course clinical trials. Journal of the American Statistical Association 2002; 97:29-39.

• Inoue LYT, Thall PF, Berry DA. Seamlessly expanding a randomized phase II trial to phase III. Biometrics 2002; 58:823-831.

• Thall PF, Wathen JK, Bekele BN, Champlin RE, Baker LO, Benjamin RS. Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes. Statistics in Medicine. (2002, in press)

• Thall PF. Ethical issues in oncology biostatistics. Statistical Methods in Medical Research 2002; 11:429-448. (Invited)

• Thall PF, Inoue LYT, Martin T. Adaptive decision making in a lymphocyte infusion trial. Biometrics 2002; 58:560-568.

• Thall PF, Sung H-G, Estey EH. Multi-course treatment strategies in clinical trials of rapidly fatal diseases (with discussion). Invited paper, Case Studies in Bayesian Statistics VI, Carnegie Mellon University, 2002; 33-89.

• Stallard N, Thall PF. Decision-theoretic designs for pre-phase II screening trials in oncology. Biometrics 2001; 57(4):1089-1095.

• Thall PF, Sung, H-G, Choudhury A. Dose-finding based on feasibility and toxicity in T- cell infusion trials. Biometrics 2001; 57:914-921.

• Thall PF, Cheng SC. Optimal two-stage designs for clinical trials based on safety and efficacy. Statistics in Medicine 2001; 20:1023-1032.

• Staniswalis JG, Thall PF. An explanation of generalized profile likelihoods. Statistics and Computing 2001; 11:293-298.

• Thall PF. Bayesian clinical trial design in a cancer center. Chance 2001; 14:23-28.

• Thall PF, Millikan R, Sung H-G. Evaluating multiple treatment courses in clinical trials. Statistics in Medicine 2000; 19(8):1011-1028.

• Thall PF, Simon RM, Shen Y. Approximate Bayesian evaluation of multiple treatment effects. Biometrics 2000; 56(1):213-219.

• Stallard N, Thall PF, Whitehead J.  Decision theoretic designs for phase II clinical trials with multiple outcomes.  Biometrics 1999; 55:971-977.

• Thall PF, Cheng SC.  Treatment comparisons based on two-dimensional safety and efficacy alternatives in oncology trials. Biometrics 1999; 55:746-753.

• Thall PF, Estey EH, Sung H-G. A new statistical method for dose-finding based on efficacy and toxicity in early phase clinical trials. Investigational New Drugs 1999; 17(2):155-167.

• Thall PF, Lee JJ, Tseng C-H, Estey E. Accrual strategies for phase I trials with delayed patient outcome. Statistics in Medicine 1999; 18(10):1155-1169.

• Shen Y, Thall PF. Parametric likelihoods for multiple non-fatal competing risks and death. Statistics in Medicine 1998; 17:999-1016.

• Thall PF, Russell KT. A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 1998; 54:251-264.

• Thall PF, Sung HG. Some extensions and applications of a Bayesian strategy for monitoring multiple outcomes in clinical trials. Statistics in Medicine 1998; 17:1563-1580.

• Staniswalis JG, Thall PF, Salch J. Semiparametric regression analysis for recurrent event interval counts. Biometrics 1997; 53:1334-1353.

• Thall PF, Russell KT, Simon RM. Variable selection in regression via repeated data splitting. Journal of Computational and Graphical Statistics 1997; 6:416-434.

• Thall PF, Jacoby D, Zimmerman SO. Estimating genomic category probabilities from fluorescent in situ hybridization counts with misclassification. Applied Statistics 1996; 45:431-446.

• Thall PF, Simon RM, Estey EH. New statistical strategy for monitoring safety and efficacy in single-arm clinical trials. Journal of Clinical Oncology 1996; 14:296-303.

• Thall PF, Simon R, Estey EH. Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Statistics in Medicine 1995; 14:357-379.

• Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Statistics in Medicine 1994; 13:1727-1736.

• Simon R, Thall PF, Ellenberg SS. New designs for the selection of treatments to be tested in randomized clinical trials. Statistics in Medicine 1994; 13:417-429.

• Thall PF, Simon R. Practical Bayesian guidelines for phase IIB clinical trials. Biometrics 1994; 50:337-349.

• Thall PF, Simon RA Bayesian approach to establishing sample size and monitoring criteria for phase II clinical trials. Controlled Clinical Trials 1994; 15:463-481.

• Thall PF, Estey E. A Bayesian strategy for screening cancer treatments prior to Phase II clinical evaluation. Statistics in Medicine 1993; 12:1197-1211.

• Thall PF. Score tests in the two-way layout of counts. Communications in Statistics: Theory and Methods 1992; 21:3017-3036.

• Thall PF, Simon R, Grier DA. Test-based variable selection via cross-validation. Journal of Computational and Graphical Statistics 1992; 1:41-61.

• Thall PF, Simon R. Incorporating historical control data in planning Phase II clinical trials. Statistics in Medicine 1990; 9:215-228.

• Thall PF, Vail SC. Some covariance models for longitudinal count data with overdispersion. Biometrics 1990; 46:657-671.

• Halperin, M, Hamdy M, Thall PF. Distribution-free confidence intervals for a parameter of Wilcoxon-Mann-Whitney type for ordered categories and progressive censoring. Biometrics 1989; 45:509-521.

• Thall PF, Simon R, Ellenberg SS. A two-stage design for choosing among several experimental treatments and a control in clinical trials. Biometrics 1989; 45: 537-547.

• Thall PF. Mixed Poisson likelihood regression models for longitudinal interval count data. Biometrics 1988; 44: 197-209.

• Thall PF, Lachin JM. Analysis of recurrent events: nonparametric methods for random interval count data. Journal of the American Statistical Association 1988; 83: 339-347.

• Thall PF, Simon R, Ellenberg SS. Two-stage selection and testing designs for comparative clinical trials. Biometrika 1988; 75:303-310.

• Thall PF, Simon R, Ellenberg SS, Shrager R. Optimal two-stage designs for clinical trials with binary response. Statistics in Medicine 1988; 71:571-579.

• Thall PF, Lachin JM. Assessment of stratum-covariate interactions in Cox S proportional hazards regression model. Statistics in Medicine 1986; 5:73-83.

• Thall PF. A theorem on regular infinitely divisible Cox processes. Stochastic Processes and Their Applications 1983; 16:205-210.

• Kimeldorf G, Thall PF. A joint characterization of the multinomial distribution and the poisson process. Journal of Applied Probability 1981; 20:202-208.

• Thall PF. Cluster shock models. Journal of Applied Probability 1981; 18:104-111.

• Ammann LP, Thall PF. Count distributions, orderliness and invariance of poisson cluster processes. Journal of Applied Probability 1979; 16:261-273.

• Thall PF. Huber-sense robust M-estimation of a scale parameter with application to the exponential distribution. Journal of the American Statistical Association 1979; 74:147-152.

• Ammann LP, Thall PF. Random measures with aftereffects. Annals of Probability 1978; 6:216-230.

• Ammann LP, Thall PF. On the structure of regular infinitely divisible point processes. Stochastic Processes and Their Applications 1977; 6:87-94.

• Kullback S, Thall PF. An information-theoretic proof of the integral representation theorem. Journal of Combinatorics, Information and System Sciences 1977; 2:97-103.

Medical publications

• Daliani DD, Assikis V, Tu S-M, Papandreou N, Pagliaro LC, Holtkamp T, Wang X, Thall PF, Logothetis CJ. Phase II trial of cyclophosphamide, vincristine and dexmethasone in the treatment of androgen independent prostate cancer. Cancer (In press, 2003).

• Millikan R, Thall PF, Lee S-J, Jones D, Cannon MW, Kuebler JP, Wade III J, Logothetis CJ. Randomized multicenter phase II trial of two multicomponent regimens in androgen independent prostate cancer. Journal of Clinical Oncology. (In press, 2003).

• Weiner JR, Windham TC, Estrella VC, Parikh NU, Thall PF, Deavers MT, Bast RC, Mills GB, Gallick GE. Activated src protein tyrosine kinase is overexpressed in late-stage human ovarian cancers. Gynecologic Oncology. (In press, 2003).

• Faderl S, Thall PF, Estrov Z. Time to platelet recovery predicts outcome of patients with de novo acute lymphoblastic leukemia who have achieved a complete remission. British Journal of Hematology 2002; 117:869-874.

• Estey EH, Thall PF, Wang X, et al. Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated AML and high-risk MDS: comparison with idarubicin + continuous-infusion high-dose cytosine arabinoside. Blood 2002; 99:4343-4349.

• Daliani DD, Papandreou CN, Thall PF, Wang X, Perez C, Oliva R, Pagliaro L, Amato R. A pilot study of thalidomide in patients with advanced metastatic renal cell carcinoma. Cancer 2002; 95:758-765.

• Papandreou CN, Daliani DD, Thall PF, Tu S-M, Wang X, Pagliaro L, Troncoso P, Logothetis CJ. Results of a phase II study with doxorubicin, etoposide and cisplatin in patients with fully characterized small cell carcinoma of the prostate. Journal of Clinical Oncology 2002; 20:3072-3080.

• Andersson BS, Thall PF, Madden T, Couriel D, Wang X, Tran HT, Anderlini P, deLima M, Gajewski J, Champlin RE. Busulfan systemic exposure relative to regimen-related toxicity and acute graft vs. host disease; defining a therapeutic window for IVBuCy2 in Chronic Myelogenous Leukemia. Biology of Blood and Marrow Transplantation 2002; 8:477-485.

• Tseng J, Glisson B, Khuri F, Shin D, Myers J, El-Naggar A, Roach J, Ginsberg L, Thall PF, Wang X, Teddy S, Lawhorn K, Zentgraf R, Steinhaus G, Abbruzzese J, Hong WK, Herbst R. Phase II study of the anti-angiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer 2001; 92(9):2364-2373.

• Estey E, Thall PF, Cortes JE, Giles FJ, O'Brien S, Pierce SA, Wang X, Kantarjian HM, Beran M. Comparison of idarubicin + ara-C, fludarabine + ara-C, and topotecan + ara-C-based regimens in treatment of newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts. Blood 2001; 98(13):3575-3583.

• Giralt S, Thall PF, et al. Melphalan and purine analog-containing preparative regimens: reduced-intensity conditioning for patients with hematologic malignancies undergoing allogeneic progenitor cell transplantation. Blood 2001; 97(3):631-637.

• Dougherty TB, Porsche VH, Thall PF. Maximum tolerated dose of nalmefene in patients receiving epidural fentanyl and dilute bupivacaine for postoperative analgesia. Anesthesiology 2000; 92(4):1010-1016.

• Estey EH, Shen Y, Thall PF. Effect of time to complete remission on subsequent survival and disease-free survival time in AML, RAEB-t, and RAEB. Blood 2000; 95(1):72-77.

• Seong C-M, Giralt S, Kantarjian H, Xu J, Swantkowski J, Hayes K, Glassman AB, Khouri I, Korbling M, Thall P, Siciliano MJ, Champlin RE. Early detection of relapse by hypermetaphase FISH after allogeneic bone marrow transplantation for chronic myelogenous leukemia. Journal of Clinical Oncology 2000; 18(9):1831-1836.

• Albitar M, Dong Q, Saunder D, Lucas L, Kaabi L, Zaldivar E, Thall PF. Evaluation of automated leukocyte differential counts in a cancer center. Laboratory Hematology 1999; 5:10-14.

• Estey E, Thall PF, Pierce S. Randomized phase II study of fludarabine +cytosine arabinoside+ idarubicin +/- all trans retinoic acid +/- granulocyte-colony stimulating factor in poor prognosis newly diagnosed acute myeloid leukemia and myelodysplastic syndrome. Blood 1999; 93(8):2478-2484.

• Estey EH, Thall PF, Reed P, Dong Q, Kantarjian H, Pierce S, Keating M. Treatment of newly diagnosed AML, RAEB-t or RAEB with lisofylline or placebo in addition to chemotherapy. Leukemia 1999; 13(6):850-854.

• Faderl S, Thall PF, Kantarjian HM, Talpaz M, Pierce S, Harris D, Van Q, Estrov Z. Caspase 2 and caspase 3 as predictors of complete remission survival in adults with acute lymphoblastic leukemia. Clinical Cancer Research 1999; 5(12):4041-4047.

• Gershenson DM, Morris M, Burke TW, Levenback C, Wolf J, Lee J J, Thall PF, Atkinson EN, Silva EG, Wharton JT. A phase I trial of intravenous melphalan, paclitaxel, and cisplatin plus granulocyte colony-stimulating factor in patients with suboptimal advanced epithelial ovarian cancer or peritoneal cancer. Cancer 1999; 86(11):2291-2300.

• Kornblau S, Thall PF, Estrov Z, et al. The prognostic impact of BCL2 protein expression in acute myelogenous leukemia varies with cytogenetics. Clinical Cancer Research 1999; 5(7):1758-1766.

• Przepiorka D, Khouri I, Thall PF, Mehra R, Lee M-S, Ippoliti C, Giralt S, Gajewski J, van Besien K, Andersson B, Korbling M, Deisseroth A, Champlin R. Thiotepa, busulfan and cyclophosphamide as a preparative regimen for allogeneic transplantation for advanced chronic myelogenous leukemia. Bone Marrow Transplantation 1999; 23:977-981.

• Estrov Z, Thall PF, Talpaz M, Estey EH, Kantarjian HM, Andreeff M, Harris D, Van Q, Walterscheid M, Kornblau SM. Caspase 2 and caspase 3 protein levels as predictors of survival in acute myelogenous leukemia. Blood 1998; 92(9):3090-3097.

• Price KJ, Thall PF, Kish SK, Shannon VR, Andersson BS. Prognostic indicators for blood and marrow transplant patients admitted to an intensive care unit. American Journal of Respiratory and Critical Care Medicine 1998; 158(3):876-884.

• Seong D, Thall P, Kantarjian H, Talpaz M, Swantkowski J, Xu J, Shen Y, Glassman A, Ramagli L, Siciliano M. Philadelphia chromosome-positive myeloid cells in the peripheral blood of chronic myelogenous leukemia patients: comparison with the frequency detected in cycling cells of the bone marrow. Clinical Cancer Research 1998; 4:861-867.

• Wright-Browne V, Schnee AM, Jenkins MA, Thall PF, Aggarwal BB, Talpaz M, Estrov Z. Serum cytokine levels in infectious mononucleosis at diagnosis and convalescence. Leukemia and Lymphoma 1998; 30:583-589.

• Estey E, Thall PF, Beran M, Kantarjian H, Pierce S, Keating M. Effect of diagnosis (RAEB, RAEB-t, or AML) on outcome of AML-type chemotherapy. Blood 1997; 90:2969-2977.

• Estey EH, Thall PF, Pierce S, Kantarjian H, Keating M. Treatment of newly diagnosed acute promyelocytic leukemia without cytarabine. Journal of Clinical Oncology 1997; 15:483-490.

• Estey E, Thall PF, Pierce S, Kantarjian H, Keating M, Freireich E. Association between increased body mass index and a diagnosis of acute promyelocytic leukemia in patients with acute myeloid leukemia. Leukemia 1997; 11:1661-1664.

• O’Brien S, Thall PF, Siciliano MJ. Cytogenetics of CML. Baillier S Clinical Hematology 1997; 10:259-276.

• Przepiorka D, Anderlini P, Ippoliti C, Khouri I, Fietz T, Thall PF, et al. Allogeneic blood stem cell transplantation in advanced hematologic cancers. Bone Marrow Transplantation 1997; 19:455-460.

• Van Besien K, Thall PF, et al. Allogeneic transplantation for recurrent or refractory non-Hodgkin’s lymphoma with poor prognostic features after conditioning with thiotepa, busulfan, cyclophosphamide. Experience in 42 consecutive patients. Biology of Blood and Marrow Transplantation 1997; 3:150-156.

• Estey E, Thall P, Mehta K, Rosenblum M, Cabanillas F, Kurzrock R, Lopez-Berestein, G. Alterations in tretinoin pharmacokinetics following administration of liposomal all-trans retinoic acid. Blood 1996; 87:3650-3654.

• Hammoud MA, Sawaya R., Shi W, Thall PF, Leeds NE. Prognostic significance of preoperative MRI scans in glioblastoma multiforme. Journal of NeuroOncology 1996; 27:65-73.

• Kornblau SM, Thall PF, Huh YO, Estey EH, Andreeff M. Analysis of CD7 expression in acute myelogenous leukemia: Martingale residual plots combined with 'optimal' cutpoint analysis reveals absence of prognostic significance. Leukemia 1995; 9:1735-1741.

• Levin VA, Thall PF, et al. Phase II study of accelerated fractionation radiation therapy with carboplatin followed by PCV chemotherapy for the treatment of glioblastoma multiforme. International Journal of Radiation Oncology, Biology, nad Physics 1995; 33:257-364.

• Estey E, Thall P, et al. Use of G-CSF before, during, and after fludarabine + ara-C induction therapy of newly-diagnosed AML or MDS: comparison with fludarabine + ara-C without G-CSF. Journal of Clinical Oncology 1994; 12:671-678.

• Estey E, Thall PF, et al. Treatment of newly diagnosed acute myelogenous leukemia with GM-CSF prior to and during continuous-infusion high dose ARA-C (CHDAC) + daunorubicin: Comparison to patients without GM-CSF. Blood 1992; 79:2246-2255.

Book Chapters:

• Thall PF, Estey E. Graphical methods for evaluating covariate effects in the Cox model. In: J. Crowley (ed.), Handbook of Statistics in Clinical Oncology, pp. 411-432, New York: Marcel-Dekker, 2001.

• Millikan R, Thall PF. Statistical considerations in the phase II evaluation of new therapies. In: M. Droller (ed.), Current Clinical Urology: Bladder Cancer: Current Diagnosis and Treatment: 423-438, Totowa, NJ: Humana Press, 2001.

• Simon R, Thall PF. Phase II clinical trials. In: P. Armitage, T. Colton, (eds.), Encyclopedia of Biostatistics; Vol. 4:3370-3376, United Kingdom; John Wiley & Sons Ltd., 1998.

• Thall PF, Simon R. Recent developments in the design of phase II clinical trials. In: P. Thall (ed.), Recent Advances in the Design and Analysis of Clinical Trials: 49-71, Kluwer: Norwell, Massachusetts, 1995.

Papers in Proceedings:

• Thall PF. Bayesian methods in early phase clinical trial design. Proceedings of the Section on Bayesian Statistical Science, American Statistical Association, Joint Statistical Meetings, Indianapolis, Indiana, pp. 30-39, 2000.

• Staniswalis JG, Thall PF. An explanation of generalized profile likelihoods. Proceedings of the 29th Symposium on the Interface: Computing Science and Statistics, Houston, TX, 1997; 29(1):233-239.

• Thall PF, Simon R. Bayesian design and monitoring of Phase II clinical trials. Proceedings of the XVIth International Biometric Conference, Hamilton, New Zealand, pp.205-220, 1992.

Book Review:

• Thall PF. A review of: Lamperti J. Stochastic processes: a survey of the mathematical theory. Journal of the American Statistical Association, Springer-Verlag 1979; 74: 245-246.

Book Edited:

• Thall PF. Recent Advances in Clinical Trial Design and Analysis. Boston: Kluwer Academic Publishers, 1995.

Submitted for Publication:

• Bekele BN, Thall PF. Dose-finding based on multiple ordinal toxicities in phase I oncology trials. (2002)

• Khuri FR, Glisson BS, Kim ES, Thall PF, Meyers ML, Herbst RS, Munden RF, Zaknoen S, Baum C, Zhu Y, Statkevich P, Bangert S, Thompson E, Lu C, Wang X, Shin DM, Papadimitrakopoulou, Fossells FV, Bishop WR, Hong WK. Phase I study of the farnesyl transferase inhibitor (FTI) SCH66336 with paclitaxel in solid tumors.

• Shaw PH, Gilligan D, Wang X, Thall PF, Corey SJ. Ex vivo expansion of megakaryocyte precursors from umbilical cord blood CD34+ cells in a closed liquid culture system. (2002)

• Thall PF, Millikan RE, Müller P, Lee S-J. Dose-finding with two agents in phase I oncology trials.