E L Korn

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. ncbi request reprint Abrogation of the hematological and biological activities of the interleukin-3/granulocyte-macrophage colony-stimulating factor fusion protein PIXY321 by neutralizing anti-PIXY321 antibodies in cancer patients receiving high-dose carboplatin
    L L Miller
    Frederick Cancer Research and Development Center, Biological Response Modifiers Program, National Cancer Institute, Frederick, MD, USA
    Blood 93:3250-8. 1999
  2. ncbi request reprint Conditional power calculations for clinical trials with historical controls
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    Stat Med 25:2922-31. 2006
  3. pmc Design issues in randomized phase II/III trials
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20852, USA
    J Clin Oncol 30:667-71. 2012
  4. pmc Overall survival as the outcome for randomized clinical trials with effective subsequent therapies
    Edward L Korn
    Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 29:2439-42. 2011
  5. ncbi request reprint Assessing surrogates as trial endpoints using mixed models
    Edward L Korn
    Biometric Research Branch, EPN 8128, National Cancer Institute, Bethesda, MD 20892, USA
    Stat Med 24:163-82. 2005
  6. ncbi request reprint Preliminary data release for randomized clinical trials of noninferiority: a new proposal
    Edward L Korn
    Biometric Research Branch and Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, EPN 8128, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 23:5831-6. 2005
  7. ncbi request reprint The likelihood as statistical evidence in multiple comparisons in clinical trials: no free lunch
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20892 7434, USA
    Biom J 48:346-55. 2006
  8. ncbi request reprint An investigation of two multivariate permutation methods for controlling the false discovery proportion
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, EPN 8129, Bethesda, MD 20892 7434, USA
    Stat Med 26:4428-40. 2007
  9. ncbi request reprint A posterior tale
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20892 7434, USA
    Biom J 49:346-50. 2007
  10. ncbi request reprint A note on controlling the number of false positives
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20852 7434, USA
    Biometrics 64:227-31. 2008

Detail Information

Publications52

  1. ncbi request reprint Abrogation of the hematological and biological activities of the interleukin-3/granulocyte-macrophage colony-stimulating factor fusion protein PIXY321 by neutralizing anti-PIXY321 antibodies in cancer patients receiving high-dose carboplatin
    L L Miller
    Frederick Cancer Research and Development Center, Biological Response Modifiers Program, National Cancer Institute, Frederick, MD, USA
    Blood 93:3250-8. 1999
    ..The immunogenicity of this fusion protein provides a cautionary warning that clinical development of bioengineered human molecules requires thorough testing for immune neutralization...
  2. ncbi request reprint Conditional power calculations for clinical trials with historical controls
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    Stat Med 25:2922-31. 2006
    ..We explain why a popular method for doing these calculations is wrong, and discuss alternative methods in the context of normal outcomes, binary outcomes, and time-to-event outcomes...
  3. pmc Design issues in randomized phase II/III trials
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20852, USA
    J Clin Oncol 30:667-71. 2012
    ..We discuss these phase II/III design parameters, give examples of phase II/III trials, and provide recommendations concerning efficient phase II/III trial designs...
  4. pmc Overall survival as the outcome for randomized clinical trials with effective subsequent therapies
    Edward L Korn
    Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 29:2439-42. 2011
    ....
  5. ncbi request reprint Assessing surrogates as trial endpoints using mixed models
    Edward L Korn
    Biometric Research Branch, EPN 8128, National Cancer Institute, Bethesda, MD 20892, USA
    Stat Med 24:163-82. 2005
    ..Graphical displays are also suggested. Two sets of trial results previously analysed for trial-level surrogacy are used as examples...
  6. ncbi request reprint Preliminary data release for randomized clinical trials of noninferiority: a new proposal
    Edward L Korn
    Biometric Research Branch and Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, EPN 8128, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 23:5831-6. 2005
    ..Examples are given demonstrating how the proposal would work, along with a discussion of possible objections to the proposal...
  7. ncbi request reprint The likelihood as statistical evidence in multiple comparisons in clinical trials: no free lunch
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20892 7434, USA
    Biom J 48:346-55. 2006
    ....
  8. ncbi request reprint An investigation of two multivariate permutation methods for controlling the false discovery proportion
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, EPN 8129, Bethesda, MD 20892 7434, USA
    Stat Med 26:4428-40. 2007
    ..We find that the top-down MPT-based method probabilistically controls the FDP, whereas our implementation of the top-down SAM-based method does not. Bottom-up MPT-based or SAM-based methods can result in poor control of the FDP...
  9. ncbi request reprint A posterior tale
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20892 7434, USA
    Biom J 49:346-50. 2007
    ..The resolution of this apparent paradox is discussed as well as its relation to real-life problems involving data monitoring of clinical trials...
  10. ncbi request reprint A note on controlling the number of false positives
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20852 7434, USA
    Biometrics 64:227-31. 2008
    ..An example is given involving gene expression microarray data of breast cancer tumors...
  11. ncbi request reprint Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials
    Edward L Korn
    Biometric Research Branch, EPN 8129, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 26:527-34. 2008
    ....
  12. pmc Stopping or reporting early for positive results in randomized clinical trials: the National Cancer Institute Cooperative Group experience from 1990 to 2005
    Edward L Korn
    Biometric Research Branch and the Clinical Investigations Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    J Clin Oncol 27:1712-21. 2009
    ....
  13. pmc Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 28:5197-201. 2010
    ..We examine in detail the accrual experience of the Cooperative Group phase III trials...
  14. pmc Outcome--adaptive randomization: is it useful?
    Edward L Korn
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 29:771-6. 2011
    ....
  15. doi request reprint Inefficacy interim monitoring procedures in randomized clinical trials: the need to report
    Edward L Korn
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    Am J Bioeth 11:2-10. 2011
    ..A survey of two leading medical journals suggests that this is not current practice...
  16. ncbi request reprint Objective method of comparing DNA microarray image analysis systems
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
    Biotechniques 36:960-7. 2004
    ..We demonstrate the method with a comparison of cDNA microarray data generated by the UCSF Spot and the GenePix image processing systems...
  17. pmc Identifying pre-post chemotherapy differences in gene expression in breast tumours: a statistical method appropriate for this aim
    E L Korn
    Biometric Research Branch, EPN 8128, National Cancer Institute, National Institutes of Health, Bethesda MD 20892, USA
    Br J Cancer 86:1093-6. 2002
    ..These findings were not reported by the original investigators who analysed the data using cluster analysis techniques...
  18. ncbi request reprint Clinical trial designs for cytostatic agents: are new approaches needed?
    E L Korn
    Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 19:265-72. 2001
    ..Planned and ongoing trials will test the utility of some of these new approaches...
  19. doi request reprint Measurement error in the timing of events: effect on survival analyses in randomized clinical trials
    Edward L Korn
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    Clin Trials 7:626-33. 2010
    ....
  20. pmc Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?
    Lori E Dodd
    Division of Cancer Treatment and Diagnosis, Branches of Biometric Research, Investigational Drug, Cancer Investigations, and Diagnostic Imaging, National Cancer Institute, Rockville, MD 20892, USA
    J Clin Oncol 26:3791-6. 2008
    ..When such designs are not practical, BICR is not recommended as a general strategy for reducing bias. However, BICR may be useful as an auditing tool to assess the reliability of marginally positive results...
  21. ncbi request reprint Proposal for the use of progression-free survival in unblinded randomized trials
    Boris Freidlin
    Biometric Research Branch and the Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 25:2122-6. 2007
    ..This proposal, possibly combined with central review of progression scans for these two time points, essentially eliminates any bias, with little risk of major efficiency loss compared with using the reported progression times...
  22. ncbi request reprint Testing logistic regression coefficients with clustered data and few positive outcomes
    Sally Hunsberger
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, U S A
    Stat Med 27:1305-24. 2008
    ..The proposed method is also useful when testing goodness-of-fit of logistic regression models using deciles-of-risk tables...
  23. ncbi request reprint Lack of generalizability of sensitivity and specificity with treatment effects
    Lori E Dodd
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 6130 Executive Blvd, Bethesda, MD 20892, U S A
    Stat Med 27:1734-44. 2008
    ..These results demonstrate that evaluating sensitivity and specificity within treatment (or other covariate) groups is necessary even when simple proportional hazards models or the Prentice criterion holds...
  24. ncbi request reprint Randomized clinical trial design for assessing noninferiority when superiority is expected
    Boris Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 25:5019-23. 2007
    ..This hybrid design can naturally incorporate a formal test of superiority as well as noninferiority...
  25. doi request reprint Multi-arm clinical trials of new agents: some design considerations
    Boris Freidlin
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA
    Clin Cancer Res 14:4368-71. 2008
    ..Relative to conducting separate RCTs for each experimental agent, this multi-arm design is shown to require a lower total sample size than multiple two-arm trials...
  26. pmc Monitoring for lack of benefit: a critical component of a randomized clinical trial
    Boris Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 27:629-33. 2009
    ..On the other hand, we caution that some commonly used monitoring guidelines may result in stopping for lack of benefit even when a nontrivial beneficial effect is observed...
  27. doi request reprint Stopping clinical trials early for benefit: impact on estimation
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, MD, USA
    Clin Trials 6:119-25. 2009
    ..It has been suggested in the literature that the well-known bias of treatment-effect estimators due to the possibility of early stopping for positive results is a major concern with interim monitoring...
  28. pmc Randomized clinical trials with biomarkers: design issues
    Boris Freidlin
    Biometric Research Branch, EPN 8122, National Cancer Institute, Bethesda, MD 20892, USA
    J Natl Cancer Inst 102:152-60. 2010
    ..We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility...
  29. ncbi request reprint A comment on futility monitoring
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    Control Clin Trials 23:355-66. 2002
    ..Thus, aggressive monitoring rules may fail to provide sufficiently convincing evidence to influence clinical practice or to establish a standard of treatment...
  30. ncbi request reprint Release of data from an ongoing randomized clinical trial for sample size adjustment or planning
    Boris Freidlin
    Biometric Research Branch, EPN 8122, National Cancer Institute, Bethesda, MD 20892 7434, USA
    Stat Med 26:4074-82. 2007
    ..A simple approach to minimizing the effect of the data release is suggested...
  31. ncbi request reprint Correcting log ratios for signal saturation in cDNA microarrays
    Lori E Dodd
    Biometric Research Branch, DCTD, National Cancer Institute, Bethesda, MD 20892 7434, USA
    Bioinformatics 20:2685-93. 2004
    ..In practice, spots with saturated pixels are discarded or the biased value is used. Neither of these approaches is appealing, particularly the former approach when a highly expressed gene is discarded because of saturation...
  32. ncbi request reprint A testing procedure for survival data with few responders
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, 6130 Executive Blvd EPN 8122, MSC 7434, Bethesda, MD 20892 7434, USA
    Stat Med 21:65-78. 2002
    ..Use of the procedure is illustrated with data from two published randomized studies...
  33. ncbi request reprint Chromosome transfer induced aneuploidy results in complex dysregulation of the cellular transcriptome in immortalized and cancer cells
    Madhvi B Upender
    Genetics Branch and Laboratory for Biosystems and Cancer, Center for Cancer Research and Biometric Research Branch, National Cancer Institute NIH, Bethesda, Maryland 20892 8010, USA
    Cancer Res 64:6941-9. 2004
    ..We therefore postulate that the genomic imbalances observed in cancer cells exert their effect through a complex pattern of transcriptional dysregulation...
  34. ncbi request reprint A general inefficacy interim monitoring rule for randomized clinical trials
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, MD, USA
    Clin Trials 7:197-208. 2010
    ..To balance patient interests against the need for acquiring evidence it is desirable to stop a study for inefficacy as soon as convincing evidence that the new therapy is not beneficial becomes available...
  35. ncbi request reprint Testing treatment effects in the presence of competing risks
    Boris Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 6130 Executive Blvd EPN 8122, MSC 7434, Bethesda, MD 20892 7434, USA
    Stat Med 24:1703-12. 2005
    ....
  36. ncbi request reprint Dose escalation trial designs based on a molecularly targeted endpoint
    Sally Hunsberger
    Biometrics Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
    Stat Med 24:2171-81. 2005
    ..A limited simulation study is performed and the designs are compared with respect to the dose level at the end of escalation and the number of patients treated on study...
  37. ncbi request reprint Design issues of randomized phase II trials and a proposal for phase II screening trials
    Lawrence V Rubinstein
    Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA
    J Clin Oncol 23:7199-206. 2005
    ....
  38. ncbi request reprint Design of a binary biomarker study from the results of a pilot study
    Paul S Albert
    Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892 7434, USA
    Biometrics 58:576-85. 2002
    ..We illustrate the methodology with data from a study assessing the reproducibility of p53 immunohistochemistry in bladder tumors...
  39. ncbi request reprint Stage-specific alterations of the genome, transcriptome, and proteome during colorectal carcinogenesis
    Jens K Habermann
    Genetics Branch, National Cancer Institute, NIH, Bethesda, MD 20892 8010, USA
    Genes Chromosomes Cancer 46:10-26. 2007
    ..The identification of novel genes and proteins might deliver molecular targets for diagnostic and therapeutic interventions...
  40. ncbi request reprint Selecting drug combinations based on total equivalent dose (dose intensity)
    R Simon
    Biometric Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892
    J Natl Cancer Inst 82:1469-76. 1990
    ..The method described here offers one approach to identifying combinations worthy of evaluation in prospective trials...
  41. ncbi request reprint Predictive margins with survey data
    B I Graubard
    Biostatistics Branch, National Cancer Institute, Bethesda, Maryland 20892, USA
    Biometrics 55:652-9. 1999
    ..Applications are given using data from the 1992 National Health Interview Survey (NHIS) and the Epidemiologic Followup Study to the first National Health and Nutrition Examination Survey (NHANES I)...
  42. ncbi request reprint A prospective randomized phase II trial of GM-CSF priming to prevent topotecan-induced neutropenia in chemotherapy-naive patients with malignant melanoma or renal cell carcinoma
    J E Janik
    Frederick Cancer Research and Development Center, Biological Response Modifiers Program, National Cancer Institute, National Institutes of Health, Frederick, MD, USA
    Blood 97:1942-6. 2001
    ..One partial response was seen in a patient with melanoma, and one patient with renal cell cancer had complete regression of pulmonary metastases and was rendered disease-free by nephrectomy. (Blood. 2001;97:1942-1946)..
  43. pmc Breast cancer classification and prognosis based on gene expression profiles from a population-based study
    Christos Sotiriou
    Division of Clinical Sciences, National Cancer Institute, Advanced Technology Center, 8717 Grovemont Circle, Gaithersburg, MD 20877, USA
    Proc Natl Acad Sci U S A 100:10393-8. 2003
    ..When taken together with other array studies, our results highlight the consistent biological and clinical associations with gene expression profiles...
  44. doi request reprint Assessing causal relationships between treatments and clinical outcomes: always read the fine print
    B Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 6130 Executive Plaza, Bethesda, MD 20892, USA
    Bone Marrow Transplant 47:626-32. 2012
    ..At the same time, we illustrate how careful application of special statistical methods for assessment of treatment-outcome causation can be instrumental in complementing existing randomized evidence and guiding design of future research...
  45. ncbi request reprint Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute
    M A Smith
    Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 15:2736-43. 1997
    ..To describe the rationale for independent data monitoring committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III cooperative group clinical trials...
  46. ncbi request reprint Multinomial phase II trial designs
    Boris Freidlin
    J Clin Oncol 20:599. 2002
  47. ncbi request reprint Early average change in tumor size in a phase 2 trial: efficient endpoint or false promise?
    Larry V Rubinstein
    J Natl Cancer Inst 99:1422-3. 2007
  48. ncbi request reprint Data monitoring and large apparent treatment effects
    Edward L Korn
    Control Clin Trials 25:67-9; author reply 71-2. 2004
  49. ncbi request reprint Strength of accumulating evidence and data monitoring committee decision making
    Stephen L George
    Department of Biostatistics and Bioinformatics, Box 3958, Duke University Medical Center, Durham, NC 27710, USA
    Stat Med 23:2659-72. 2004
    ..In this paper we present results of a survey of 21 DMC members conducted to investigate how they evaluate accumulating evidence. The results indicate that some DMC members may be over-interpreting developing trends in the data...
  50. ncbi request reprint A testing procedure for survival data with few responders
    Boris Freidlin
    Stat Med 23:1818-23. 2004
  51. ncbi request reprint Erythropoietin to treat anaemia in patients with head and neck cancer
    Boris Freidlin
    Lancet 363:81; author reply 81-2. 2004
  52. ncbi request reprint Nontoxicity endpoints in phase I trial designs for targeted, non-cytotoxic agents
    Edward L Korn
    J Natl Cancer Inst 96:977-8. 2004