Design and Analysis of Oncology Clinical Trials

[1]  B. Storer.  Phase I Trials , 2005 .

[2]  S. Piantadosi.  Clinical Trials : A Methodologic Perspective , 2005 .

[3]  P. Thall,et al.  New designs for phase 2 clinical trials. , 2003, Blood.

[4]  Anastasia Ivanova,et al.  Improved up‐and‐down designs for phase I trials , 2003, Statistics in medicine.

[5]  Gary L Rosner,et al.  Randomized discontinuation design: application to cytostatic antineoplastic agents. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  M. Parmar,et al.  Designing randomised trials: both large and small trials are needed. , 2002, Annals of oncology : official journal of the European Society for Medical Oncology.

[7]  Katherine S Panageas,et al.  An optimal two-stage phase II design utilizing complete and partial response information separately. , 2002, Controlled clinical trials.

[8]  J. Karlawish,et al.  The continuing unethical conduct of underpowered clinical trials. , 2002, JAMA.

[9]  R. Schilsky,et al.  UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity , 2002, The Pharmacogenomics Journal.

[10]  D. Spiegelhalter,et al.  Monitoring of large randomised clinical trials: a new approach with Bayesian methods , 2001, The Lancet.

[11]  S H Jung,et al.  Graphical search for two-stage designs for phase II clinical trials. , 2001, Controlled clinical trials.

[12]  J. Pignon,et al.  Meta-analyses of randomised clinical trials in oncology. , 2001, The Lancet. Oncology.

[13]  D. Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. , 2001, Annals of internal medicine.

[14]  D. Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials , 2001, The Lancet.

[15]  D H Leung,et al.  Isotonic designs for phase I trials. , 2001, Controlled clinical trials.

[16]  R Simon,et al.  Clinical trial designs for cytostatic agents: are new approaches needed? , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[17]  J G Ibrahim,et al.  Longitudinal design for phase I clinical trials using the continual reassessment method. , 2000, Controlled clinical trials.

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

[19]  R. Simon,et al.  A model to select chemotherapy regimens for phase III trials for extensive-stage small-cell lung cancer. , 2000, Journal of the National Cancer Institute.

[20]  R J Carroll,et al.  Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. , 2000, Controlled clinical trials.

[21]  Geert Molenberghs,et al.  Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis , 2000, The Lancet.

[22]  M. van Glabbeke,et al.  New guidelines to evaluate the response to treatment in solid tumors , 2000, Journal of the National Cancer Institute.

[23]  T. Chen,et al.  Optimal two-stage designs for phase ii clinical trials with differentiation of complete and partial responses , 2000 .

[24]  B. Turnbull,et al.  Group Sequential Methods with Applications to Clinical Trials , 1999 .

[25]  S. Anderson,et al.  Sample size determination in complex clinical trials comparing more than two groups for survival endpoints. , 1998, Statistics in medicine.

[26]  Mike Clarke,et al.  Polychemotherapy for early breast cancer: an overview of the randomised trials , 1998, The Lancet.

[27]  Mike Clarke,et al.  Tamoxifen for early breast cancer: an overview of the randomised trials , 1998, The Lancet.

[28]  T. Chen,et al.  Optimal three-stage designs for phase II cancer clinical trials. , 1997, Statistics in medicine.

[29]  Stephanie Green,et al.  Clinical Trials in Oncology , 1997 .

[30]  D. Heitjan,et al.  Bayesian interim analysis of phase II cancer clinical trials. , 1997, Statistics in medicine.

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

[32]  R. Simon,et al.  Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[33]  M R Conaway,et al.  Designs for phase II trials allowing for a trade-off between response and toxicity. , 1996, Biometrics.

[34]  R Simon,et al.  Assessing whether to perform a confirmatory randomized clinical trial. , 1996, Journal of the National Cancer Institute.

[35]  D. Berry.  When is a confirmatory randomized clinical trial needed? , 1996, Journal of the National Cancer Institute.

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

[37]  J. Bryant,et al.  Incorporating toxicity considerations into the design of two-stage phase II clinical trials. , 1995, Biometrics.

[38]  J H Shih,et al.  Sample size calculation for complex clinical trials with survival endpoints. , 1995, Controlled clinical trials.

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

[40]  M R Conaway,et al.  Bivariate sequential designs for phase II trials. , 1995, Biometrics.

[41]  P. Thall,et al.  Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. , 1995, Statistics in medicine.

[42]  D A Berry.  Decision analysis and Bayesian methods in clinical trials. , 1995, Cancer treatment and research.

[43]  Peter F. Thall,et al.  Recent Advances in Clinical Trial Design and Analysis , 1995, Cancer Treatment and Research.

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

[45]  P F Thall,et al.  An optimal three-stage design for phase II clinical trials. , 1994, Statistics in medicine.

[46]  S L George,et al.  Stopping a clinical trial early: frequentist and Bayesian approaches applied to a CALGB trial in non-small-cell lung cancer. , 1994, Statistics in medicine.

[47]  D J Spiegelhalter,et al.  The CHART trials: Bayesian design and monitoring in practice. CHART Steering Committee. , 1994, Statistics in medicine.

[48]  P F Thall,et al.  Practical Bayesian guidelines for phase IIB clinical trials. , 1994, Biometrics.

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

[50]  B E Storer,et al.  Small-sample confidence sets for the MTD in a phase I clinical trial. , 1993, Biometrics.

[51]  P Y Liu,et al.  Selection designs for pilot studies based on survival. , 1993, Biometrics.

[52]  T M Therneau,et al.  How many stratification factors are "too many" to use in a randomization plan? , 1993, Controlled clinical trials.

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

[54]  S Hellman,et al.  Of mice but not men. Problems of the randomized clinical trial. , 1991, The New England journal of medicine.

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

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

[57]  R. Simon,et al.  Optimal two-stage designs for phase II clinical trials. , 1989, Controlled clinical trials.

[58]  R. Wittes,et al.  Research Methods in Clinical Oncology , 1988 .

[59]  E. Lakatos,et al.  Sample sizes based on the log-rank statistic in complex clinical trials. , 1988, Biometrics.

[60]  H. Rockette,et al.  Limitations and advantages of meta-analysis in clinical trials. , 1988, Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer.

[61]  J M Lachin,et al.  Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. , 1986, Biometrics.

[62]  E. Marubini,et al.  The use of historical controls in breast cancer. An assessment in three consecutive trials. , 1985, Controlled clinical trials.

[63]  S S Ellenberg,et al.  Randomized phase II clinical trials. , 1985, Cancer treatment reports.

[64]  W. Dupont.  Randomized vs. historical clinical trials. Are the benefits worth the cost? , 1985, American journal of epidemiology.

[65]  Gail Mh.  Eligibility exclusions, losses to follow-up, removal of randomized patients, and uncounted events in cancer clinical trials. , 1985 .

[66]  M. Buyse,et al.  Cancer Clinical Trials: Methods and Practice. , 1985 .

[67]  C. Moertel.  Improving the efficiency of clinical trials: a medical perspective. , 1984, Statistics in medicine.

[68]  E. Gehan,et al.  The evaluation of therapies: historical control studies. , 1984, Statistics in Medicine.

[69]  C. Redmond,et al.  The methodologic dilemma in retrospectively correlating the amount of chemotherapy received in adjuvant therapy protocols with disease-free survival. , 1983, Cancer treatment reports.

[70]  D. Harrington.  A class of rank test procedures for censored survival data , 1982 .

[71]  T R Fleming,et al.  One-sample multiple testing procedure for phase II clinical trials. , 1982, Biometrics.

[72]  L. Freedman.  Tables of the number of patients required in clinical trials using the logrank test. , 1982, Statistics in medicine.

[73]  D. Byar.  Why data bases should not replace randomized clinical trials. , 1980, Biometrics.

[74]  R. Prentice.  Linear rank tests with right censored data , 1978 .

[75]  S. Pocock,et al.  Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. , 1975, Biometrics.

[76]  I. Todd,et al.  The Design of Clinical Trials in Cancer Therapy , 1972, British Journal of Cancer.

[77]  J. Peto,et al.  Asymptotically Efficient Rank Invariant Test Procedures , 1972 .

[78]  David R. Cox,et al.  Regression models and life tables (with discussion , 1972 .

[79]  N. Mantel.  Evaluation of survival data and two new rank order statistics arising in its consideration. , 1966, Cancer chemotherapy reports.

[80]  E. Gehan.  A GENERALIZED WILCOXON TEST FOR COMPARING ARBITRARILY SINGLY-CENSORED SAMPLES. , 1965, Biometrika.

[81]  E. Gehan,et al.  The determinatio of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. , 1961, Journal of chronic diseases.

[82]  E. Kaplan,et al.  Nonparametric Estimation from Incomplete Observations , 1958 .