Model-Based Designs Considering Toxicity Alone

[1]  M. Sweeting,et al.  A Bayesian model‐free approach to combination therapy phase I trials using censored time‐to‐toxicity data , 2018, Journal of the Royal Statistical Society. Series C, Applied statistics.

[2]  Thomas M Braun,et al.  Motivating sample sizes in adaptive Phase I trials via Bayesian posterior credible intervals , 2018, Biometrics.

[3]  P. Thall,et al.  Subgroup‐specific dose finding in phase I clinical trials based on time to toxicity allowing adaptive subgroup combination , 2018, Pharmaceutical statistics.

[4]  S. Morita,et al.  Bayesian dose‐finding phase I trial design incorporating historical data from a preceding trial , 2018, Pharmaceutical statistics.

[5]  P. Thall,et al.  A simulation study of methods for selecting subgroup‐specific doses in phase 1 trials , 2017, Pharmaceutical statistics.

[6]  Ying Yuan,et al.  A default method to specify skeletons for Bayesian model averaging continual reassessment method for phase I clinical trials , 2017, Statistics in medicine.

[7]  Ying Yuan,et al.  BAYESIAN DATA AUGMENTATION DOSE FINDING WITH CONTINUAL REASSESSMENT METHOD AND DELAYED TOXICITY. , 2013, The annals of applied statistics.

[8]  Ying Kuen Cheung,et al.  Sample size formulae for the Bayesian continual reassessment method , 2013, Clinical trials.

[9]  Sarah Zohar,et al.  Using the continual reassessment method to estimate the minimum effective dose in phase II dose-finding studies: a case study , 2013, Clinical trials.

[10]  Donna P. Ankerst,et al.  Handbook of statistics in clinical oncology , 2012 .

[11]  N. Ishizuka,et al.  A Continual Reassessment Method that Adaptively Changes the Prior Distribution According to the Initial Cohort Observation , 2012 .

[12]  John O'Quigley,et al.  Continual Reassessment Method for Partial Ordering , 2011, Biometrics.

[13]  Ying Yuan,et al.  Robust EM Continual Reassessment Method in Oncology Dose Finding , 2011, Journal of the American Statistical Association.

[14]  Sarah Zohar,et al.  Incorporating lower grade toxicity information into dose finding designs , 2011, Clinical trials.

[15]  Ying Kuen Cheung,et al.  Calibration of prior variance in the Bayesian continual reassessment method , 2011, Statistics in medicine.

[16]  Alexia Iasonos,et al.  Continual reassessment and related designs in dose‐finding studies , 2011, Statistics in medicine.

[17]  D. Bandyopadhyay,et al.  Proportional odds model for dose‐finding clinical trial designs with ordinal toxicity grading , 2011, Statistics in medicine.

[18]  Alexia Iasonos,et al.  Estimating the dose–toxicity curve in completed phase I studies , 2011, Statistics in medicine.

[19]  Sarah Zohar,et al.  An approach to meta‐analysis of dose‐finding studies , 2011, Statistics in medicine.

[20]  John O'Quigley,et al.  Extended model‐based designs for more complex dose‐finding studies , 2011, Statistics in medicine.

[21]  Satoshi Morita,et al.  Application of the continual reassessment method to a phase I dose‐finding trial in Japanese patients: East meets West , 2011, Statistics in medicine.

[22]  M. Polley.  Practical modifications to the time‐to‐event continual reassessment method for phase I cancer trials with fast patient accrual and late‐onset toxicities , 2011, Statistics in medicine.

[23]  S Zohar,et al.  Dose‐finding approach for dose escalation with overdose control considering incomplete observations , 2011, Statistics in medicine.

[24]  J O'Quigley,et al.  Posterior maximization and averaging for Bayesian working model choice in the continual reassessment method , 2011, Statistics in medicine.

[25]  John O'Quigley,et al.  Dose-finding design for multi-drug combinations , 2011, Clinical trials.

[26]  T. Braun,et al.  Beyond the 3+3 method: expanded algorithms for dose- escalation in Phase I oncology trials of two agents , 2011, Clinical trials.

[27]  Jay Bartroff,et al.  Incorporating Individual and Collective Ethics into Phase I Cancer Trial Designs , 2011, Biometrics.

[28]  T. Braun,et al.  The superiority of the time-to-event continual reassessment method to the rolling six design in pediatric oncology Phase I trials , 2011, Clinical trials.

[29]  Ying Kuen Cheung,et al.  Continual reassessment method with multiple toxicity constraints. , 2011, Biostatistics.

[30]  Ying Kuen Cheung,et al.  Dose Finding by the Continual Reassessment Method , 2011 .

[31]  John O'Quigley,et al.  Continual Reassessment and Related Dose-Finding Designs. , 2010, Statistical science : a review journal of the Institute of Mathematical Statistics.

[32]  Thomas M Braun,et al.  A Hierarchical Bayesian Design for Phase I Trials of Novel Combinations of Cancer Therapeutic Agents , 2010, Biometrics.

[33]  Mourad Tighiouart,et al.  A novel toxicity scoring system treating toxicity response as a quasi-continuous variable in Phase I clinical trials. , 2010, Contemporary clinical trials.

[34]  Sarah Zohar,et al.  Retrospective Robustness of the Continual Reassessment Method , 2010, Journal of biopharmaceutical statistics.

[35]  Yuan Ji,et al.  Risk‐Group‐Specific Dose Finding Based on an Average Toxicity Score , 2010, Biometrics.

[36]  Jay Bartroff,et al.  Approximate Dynamic Programming and Its Applications to the Design of Phase I Cancer Trials , 2010, 1011.6509.

[37]  Peter F Thall,et al.  Bayesian Models and Decision Algorithms for Complex Early Phase Clinical Trials. , 2010, Statistical science : a review journal of the Institute of Mathematical Statistics.

[38]  Arzu Onar-Thomas,et al.  A simulation-based comparison of the traditional method, Rolling-6 design and a frequentist version of the continual reassessment method with special attention to trial duration in pediatric Phase I oncology trials. , 2010, Contemporary clinical trials.

[39]  Ying Kuen Cheung,et al.  Stochastic Approximation and Modern Model-based Designs for Dose-Finding Clinical Trials. , 2010, Statistical science : a review journal of the Institute of Mathematical Statistics.

[40]  Mourad Tighiouart,et al.  Dose Finding with Escalation with Overdose Control (EWOC) in Cancer Clinical Trials , 2010, 1011.6479.

[41]  R. A. Bailey.  Author's Rejoinder to Commentaries on ‘Designs for dose‐escalation trials with quantitative responses’ , 2009 .

[42]  J. O'Quigley.  Commentary on ‘Designs for dose–escalation trials with quantitative responses’ , 2009, Statistics in medicine.

[43]  R. A. Bailey.  Designs for dose–escalation trials with quantitative responses , 2009, Statistics in medicine.

[44]  J. O'Quigley,et al.  Sensitivity of dose-finding studies to observation errors. , 2009, Contemporary clinical trials.

[45]  A Kramar,et al.  A comparison of model choices for the continual reassessment method in phase I cancer trials , 2009, Statistics in medicine.

[46]  J. Verweij,et al.  Phase I drug combination trial design: walking the tightrope. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[47]  Ying Yuan,et al.  Bayesian Model Averaging Continual Reassessment Method in Phase I Clinical Trials , 2009 .

[48]  Ying Yuan,et al.  A Latent Contingency Table Approach to Dose Finding for Combinations of Two Agents , 2009, Biometrics.

[49]  Shing M. Lee,et al.  Model calibration in the continual reassessment method , 2009, Clinical trials.

[50]  Ying Yuan,et al.  Bayesian dose finding in oncology for drug combinations by copula regression , 2009 .

[51]  Michael Branson,et al.  A Bayesian Case Study in Oncology Phase I Combination Dose-Finding Using Logistic Regression with Covariates , 2009, Journal of biopharmaceutical statistics.

[52]  Mehmet Kocak,et al.  Continual Reassessment Method vs. Traditional Empirically Based Design: Modifications Motivated by Phase I Trials in Pediatric Oncology by the Pediatric Brain Tumor Consortium , 2009, Journal of biopharmaceutical statistics.

[53]  A. Venook,et al.  Design Issues in Dose-Finding Phase I Trials for Combinations of Two Agents , 2009, Journal of biopharmaceutical statistics.

[54]  Anastasia Ivanova,et al.  Dose Finding for Continuous and Ordinal Outcomes with a Monotone Objective Function: A Unified Approach , 2009, Biometrics.

[55]  Weichung Joe Shih,et al.  Unifying CRM and EWOC designs for phase I cancer clinical trials , 2009 .

[56]  A. Ivanova,et al.  An Adaptive First in Man Dose-Escalation Study of NGX267: Statistical, Clinical, and Operational Considerations , 2009, Journal of biopharmaceutical statistics.

[57]  Sarah Zohar,et al.  Adaptive designs for dose-finding in non-cancer phase II trials: influence of early unexpected outcomes , 2008, Clinical trials.

[58]  Ying Yuan,et al.  Sequential continual reassessment method for two‐dimensional dose finding , 2008, Statistics in medicine.

[59]  O. Gerke,et al.  Authors' rejoinder to ‘Dose‐escalation designs in oncology: ADEPT and the CRM’ , 2008 .

[60]  Jianfen Shu,et al.  Dose‐escalation designs in oncology: ADEPT and the CRM , 2008, Statistics in medicine.

[61]  Oke Gerke,et al.  Optimal phase I dose‐escalation trial designs in oncology—A simulation study , 2008, Statistics in medicine.

[62]  B. Vidakovic,et al.  Patient-Specific Dose Adjustment in the Cancer Clinical Trial Setting , 2008, Pharmaceutical Medicine.

[63]  Alexia Iasonos,et al.  A Comprehensive Comparison of the Continual Reassessment Method to the Standard 3 + 3 Dose Escalation Scheme in Phase I Dose-Finding Studies , 2008, Clinical trials.

[64]  Peter F Thall,et al.  Monitoring late-onset toxicities in phase I trials using predicted risks. , 2008, Biostatistics.

[65]  Michael Branson,et al.  Critical aspects of the Bayesian approach to phase I cancer trials , 2008, Statistics in medicine.

[66]  P. Müller,et al.  Determining the Effective Sample Size of a Parametric Prior , 2008, Biometrics.

[67]  R. Chappell,et al.  Three‐dose–cohort designs in cancer phase I trials , 2008, Statistics in medicine.

[68]  Jeffrey S Barrett,et al.  Shortening the timeline of pediatric phase I trials: the rolling six design. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[69]  John Whitehead,et al.  A Bayesian Approach for Dose-Escalation in a Phase I Clinical Trial Incorporating Pharmacodynamic Endpoints , 2007, Journal of biopharmaceutical statistics.

[70]  Peter F Thall,et al.  Simultaneously optimizing dose and schedule of a new cytotoxic agent , 2007, Clinical trials.

[71]  R. Chappell,et al.  The Continual Reassessment Method for Multiple Toxicity Grades: A Bayesian Quasi‐Likelihood Approach , 2007, Biometrics.

[72]  Anastasia Ivanova,et al.  Escalation, group and A + B designs for dose‐finding trials , 2006, Statistics in medicine.

[73]  Xavier Paoletti,et al.  Using the continual reassessment method: lessons learned from an EORTC phase I dose finding study. , 2006, European journal of cancer.

[74]  Anastasia Ivanova,et al.  Bivariate isotonic design for dose‐finding with ordered groups , 2006, Statistics in medicine.

[75]  Thomas M Braun,et al.  Generalizing the TITE‐CRM to adapt for early‐ and late‐onset toxicities , 2006, Statistics in medicine.

[76]  John O'Quigley,et al.  Theoretical study of the continual reassessment method , 2006 .

[77]  Elizabeth Garrett-Mayer,et al.  The continual reassessment method for dose-finding studies: a tutorial , 2006, Clinical trials.

[78]  J. O'Quigley.  Phase I and Phase I/II Dose Finding Algorithms Using Continual Reassessment Method , 2005 .

[79]  Satoshi Morita,et al.  Practical Implementation of the Continual Reassessment Method , 2005 .

[80]  Ying Kuen Cheung,et al.  Coherence principles in dose-finding studies , 2005 .

[81]  John O'Quigley,et al.  Retrospective Analysis of Sequential Dose‐Finding Designs , 2005, Biometrics.

[82]  J. Babb,et al.  Flexible Bayesian methods for cancer phase I clinical trials. Dose escalation with overdose control , 2005, Statistics in medicine.

[83]  Yinghui Zhou,et al.  Gaining acceptability for the Bayesian decision‐theoretic approach in dose‐escalation studies , 2005 .

[84]  Peter F Thall,et al.  Determining a Maximum‐Tolerated Schedule of a Cytotoxic Agent , 2005, Biometrics.

[85]  Yinghui Zhou,et al.  Choosing the Number of Doses and the Cohort Size for Phase 1 Dose-Escalation Studies , 2005 .

[86]  Anastasia Ivanova,et al.  Two‐Dimensional Dose Finding in Discrete Dose Space , 2005, Biometrics.

[87]  Zhilong Yuan,et al.  Isotonic designs for phase I cancer clinical trials with multiple risk groups , 2004, Clinical trials.

[88]  Shyamal D Peddada,et al.  Designs for Single‐ or Multiple‐Agent Phase I Trials , 2004, Biometrics.

[89]  B. Nebiyou Bekele,et al.  Dose-Finding Based on Multiple Toxicities in a Soft Tissue Sarcoma Trial , 2004 .

[90]  Xavier Paoletti,et al.  Design efficiency in dose finding studies , 2004, Comput. Stat. Data Anal..

[91]  T. Braun,et al.  Determining a maximum tolerated cumulative dose: dose reassignment within the TITE-CRM. , 2003, Controlled clinical trials.

[92]  L. Haines,et al.  Bayesian Optimal Designs for Phase I Clinical Trials , 2003, Biometrics.

[93]  Peter F Thall,et al.  Dose‐Finding with Two Agents in Phase I Oncology Trials , 2003, Biometrics.

[94]  L. Natarajan,et al.  Interval estimates of the probability of toxicity at the maximum tolerated dose for small samples , 2003, Statistics in medicine.

[95]  John O'Quigley,et al.  Continual Reassessment Method for Ordered Groups , 2003, Biometrics.

[96]  Yinghui Zhou,et al.  Practical Implementation of Bayesian Dose-Escalation Procedures , 2003 .

[97]  Ying Kuen Cheung,et al.  A Simple Technique to Evaluate Model Sensitivity in the Continual Reassessment Method , 2002, Biometrics.

[98]  Douglas M Potter,et al.  Adaptive dose finding for phase I clinical trials of drugs used for chemotherapy of cancer , 2002, Statistics in medicine.

[99]  John Whitehead,et al.  Heterogeneity in phase I clinical trials: prior elicitation and computation using the continual reassessment method by A. Legedza and J. G. Ibrahim, Statistics in Medicine 2001; 20: 867–882 , 2002, Statistics in medicine.

[100]  John O'Quigley,et al.  Curve‐Free and Model‐Based Continual Reassessment Method Designs , 2002, Biometrics.

[101]  John O'Quigley,et al.  Non-parametric optimal design in dose finding studies. , 2002, Biostatistics.

[102]  Ying Kuen Cheung,et al.  On the Use of Nonparametric Curves in Phase I Trials with Low Toxicity Tolerance , 2002, Biometrics.

[103]  You-Gan Wang,et al.  An extension of the continual reassessment method using decision theory , 2002, Statistics in medicine.

[104]  W Sauerwein,et al.  A scheme for a dose‐escalation study when the event is lagged , 2001, Statistics in medicine.

[105]  N. Ishizuka,et al.  The continual reassessment method and its applications: a Bayesian methodology for phase I cancer clinical trials , 2001, Statistics in medicine.

[106]  A Rogatko,et al.  Patient specific dosing in a cancer phase I clinical trial , 2001, Statistics in medicine.

[107]  J G Ibrahim,et al.  Heterogeneity in phase I clinical trials: prior elicitation and computation using the continual reassessment method , 2001, Statistics in medicine.

[108]  J Whitehead,et al.  Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers. , 2001, Biostatistics.

[109]  Y K Cheung,et al.  Sequential Designs for Phase I Clinical Trials with Late‐Onset Toxicities , 2000, Biometrics.

[110]  O. Wang,et al.  A TWO-STAGE DOSE SELECTION STRATEGY IN PHASE I TRIALS WITH WIDE DOSE RANGES , 2000, Journal of biopharmaceutical statistics.

[111]  Jeffrey R. Eisele,et al.  A Curve‐Free Method for Phase I Clinical Trials , 2000, Biometrics.

[112]  Chinying J. Wang,et al.  Designs foe phase i cancer clinical trials with differentiation of graded toxicity , 2000 .

[113]  J O'Quigley,et al.  Another look at two phase I clinical trial designs. , 1999, Statistics in medicine.

[114]  A Kramar,et al.  Continual reassessment methods in phase I trials of the combination of two drugs in oncology. , 1999, Statistics in medicine.

[115]  P F Thall,et al.  Accrual strategies for phase I trials with delayed patient outcome. , 1999, Statistics in medicine.

[116]  J O'Quigley,et al.  Two-sample continual reassessment method. , 1999, Journal of biopharmaceutical statistics.

[117]  C. Ahn,et al.  An evaluation of phase I cancer clinical trial designs , 1998 .

[118]  S Zacks,et al.  Cancer phase I clinical trials: efficient dose escalation with overdose control. , 1998, Statistics in medicine.

[119]  R Simon,et al.  Accelerated titration designs for phase I clinical trials in oncology. , 1997, Journal of the National Cancer Institute.

[120]  S. Walker,et al.  A bayesian nonparametric approach to determining a maximum tolerated dose , 1997 .

[121]  S. Piantadosi,et al.  Improved designs for dose escalation studies using pharmacokinetic measurements. , 1996, Statistics in medicine.

[122]  J O'Quigley,et al.  Continual reassessment method: a likelihood approach. , 1996, Biometrics.

[123]  John O'Quigley,et al.  Consistency of continual reassessment method under model misspecification , 1996 .

[124]  S. Piantadosi,et al.  Dose-response models with covariates. , 1995, Biometrics.

[125]  S. Goodman,et al.  Some practical improvements in the continual reassessment method for phase I studies. , 1995, Statistics in medicine.

[126]  J Whitehead,et al.  Bayesian decision procedures for dose determining experiments. , 1995, Statistics in medicine.

[127]  S. Møller,et al.  An extension of the continual reassessment methods using a preliminary up-and-down design in a dose finding study in cancer patients, in order to investigate a greater range of doses. , 1995, Statistics in medicine.

[128]  M. Christian,et al.  The limited precision of phase I trials. , 1994, Journal of the National Cancer Institute.

[129]  L V Rubinstein,et al.  A comparison of two phase I trial designs. , 1994, Statistics in medicine.

[130]  J. O'Quigley,et al.  Integral evaluation for continual reassessment method. , 1994, Computer methods and programs in biomedicine.

[131]  C. Genest,et al.  Statistical Inference Procedures for Bivariate Archimedean Copulas , 1993 .

[132]  S Chevret,et al.  The continual reassessment method in cancer phase I clinical trials: a simulation study. , 1993, Statistics in medicine.

[133]  R Simon,et al.  Using the tolerable-dose diagram in the design of phase I combination chemotherapy trials. , 1993, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[134]  J O'Quigley,et al.  Estimating the probability of toxicity at the recommended dose following a phase I clinical trial in cancer. , 1992, Biometrics.

[135]  S. Chevret,et al.  Methods for dose finding studies in cancer clinical trials: a review and results of a Monte Carlo study. , 1991, Statistics in medicine.

[136]  R Simon,et al.  Selecting drug combinations based on total equivalent dose (dose intensity) , 1990, Journal of the National Cancer Institute.

[137]  J O'Quigley,et al.  Continual reassessment method: a practical design for phase 1 clinical trials in cancer. , 1990, Biometrics.

[138]  B E Storer,et al.  Design and analysis of phase I clinical trials. , 1989, Biometrics.

[139]  P. Hougaard.  A class of multivanate failure time distributions , 1986 .

[140]  M. Silvapulle.  On the Existence of Maximum Likelihood Estimators for the Binomial Response Models , 1981 .

[141]  D. Clayton.  A model for association in bivariate life tables and its application in epidemiological studies of familial tendency in chronic disease incidence , 1978 .

[142]  H. Robbins.  A Stochastic Approximation Method , 1951 .

[143]  Zheng Su.  A two-stage algorithm for designing phase I cancer clinical trials for two new molecular entities. , 2010, Contemporary clinical trials.

[144]  J Whitehead,et al.  Bayesian decision procedures based on logistic regression models for dose-finding studies. , 1998, Journal of biopharmaceutical statistics.

[145]  S. Piantadosi,et al.  Practical implementation of a modified continual reassessment method for dose-finding trials , 1998, Cancer Chemotherapy and Pharmacology.

[146]  J R Murphy,et al.  A logistic dose-ranging method for phase I clinical investigations trials. , 1997, Journal of biopharmaceutical statistics.

[147]  J. Whitehead,et al.  Bayesian decision procedures with application to dose-finding studies , 1997 .

[148]  D. Faries,et al.  Practical modifications of the continual reassessment method for phase I cancer clinical trials. , 1994, Journal of biopharmaceutical statistics.

[149]  J B Greenhouse,et al.  Bayesian methods for phase I clinical trials. , 1992, Statistics in medicine.

[150]  R. Simon,et al.  Selecting combinations of chemotherapeutic drugs to maximize dose intensity. , 1991, Journal of biopharmaceutical statistics.

[151]  Lloyd D. Fisher,et al.  Bivariate binary models of efficacy and toxicity in dose-ranging trials , 1990 .

[152]  B. Chabner,et al.  Potential roles for preclinical pharmacology in phase I clinical trials. , 1986, Cancer treatment reports.