B Freidlin

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. 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
  2. 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
  3. doi request reprint Borrowing information across subgroups in phase II trials: is it useful?
    Boris Freidlin
    Biometric Research Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda 20892, Maryland, USA
    Clin Cancer Res 19:1326-34. 2013
  4. pmc Randomized phase II trial designs with biomarkers
    Boris Freidlin
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20852, USA
    J Clin Oncol 30:3304-9. 2012
  5. 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
  6. 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
  7. 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
  8. doi 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
  9. 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
  10. doi request reprint The cross-validated adaptive signature design
    Boris Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 16:691-8. 2010

Detail Information

Publications52

  1. 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...
  2. 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...
  3. doi request reprint Borrowing information across subgroups in phase II trials: is it useful?
    Boris Freidlin
    Biometric Research Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda 20892, Maryland, USA
    Clin Cancer Res 19:1326-34. 2013
    ..When there is strong rationale for expecting a uniform level of activity across the subgroups, approaches using simple pooling of information across subgroups may be useful...
  4. pmc Randomized phase II trial designs with biomarkers
    Boris Freidlin
    Biometric Research Branch, EPN 8129, National Cancer Institute, Bethesda, MD 20852, USA
    J Clin Oncol 30:3304-9. 2012
    ..Evaluations of the proposed trial design using simulations and published data demonstrate that it works well in providing recommendations for phase III trial design...
  5. 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...
  6. 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...
  7. 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
    ....
  8. doi 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...
  9. 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...
  10. doi request reprint The cross-validated adaptive signature design
    Boris Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 16:691-8. 2010
    ..However, due to the high-dimensional nature of the genomic data, developing a reliable classifier by the time the definitive phase III trail is designed may not be feasible...
  11. 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...
  12. 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...
  13. ncbi request reprint Evaluation of randomized discontinuation design
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892 7434, USA
    J Clin Oncol 23:5094-8. 2005
    ..Single-arm phase II trials may not be appropriate for testing cytostatic agents. We evaluate two kinds of randomized designs for the early development of target-based cytostatic agents...
  14. 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...
  15. ncbi request reprint Efficiency robust tests for survival or ordered categorical data
    B Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892, USA
    Biometrics 55:883-6. 1999
    ..The second procedure, called the MX, uses the maximum of the optimal statistics. Both approaches yield efficiency robust procedures for survival analysis and ordinal categorical data. Guidelines for choosing between them are provided...
  16. 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...
  17. ncbi request reprint Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
    Boris Freidlin
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    Clin Cancer Res 11:7872-8. 2005
    ..Thus, there is a need for development of novel statistical methodology for rapid evaluation of these agents...
  18. ncbi request reprint Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect
    Wenyu Jiang
    Biometric Research Branch, Division of Cancer Treatment and Diagnosis, EPN 8122, National Cancer Institute, Bethesda, MD 20892, USA
    J Natl Cancer Inst 99:1036-43. 2007
    ..We propose a statistically rigorous biomarker-adaptive threshold phase III design for settings in which a putative biomarker to identify patients who are sensitive to the new agent is measured on a continuous or graded scale...
  19. ncbi request reprint Targeting epidermal growth factor receptor--are we missing the mark?
    Janet E Dancey
    Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, USA
    Lancet 362:62-4. 2003
    ..Appropriately designed clinical trials are required to define the optimum dose, schedule, and sequence for these agents in combination with conventional therapies and other targeted agents...
  20. ncbi request reprint A model to select regimens for phase III trials for patients with advanced-stage non-small cell lung cancer
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    Clin Cancer Res 9:917-22. 2003
    ....
  21. ncbi request reprint Unconditional versions of several tests commonly used in the analysis of contingency tables
    B Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892 7434, USA
    Biometrics 55:264-7. 1999
    ..The unconditional procedures are compared to the conditional ones by reanalyzing some published biomedical data...
  22. ncbi request reprint Robust TDT-type candidate-gene association tests
    G Zheng
    National Heart Lung and Blood Institute, Bethesda, MD 20892, USA
    Ann Hum Genet 66:145-55. 2002
    ..g. dominant through additive) a simple linear combination also performs well. In general, the MAX has better power properties than the TDT for the study of candidate genes when the mode of inheritance is unknown...
  23. ncbi request reprint On power and efficiency robust linkage tests for affected sibs
    J L Gastwirth
    Division of Cancer Genetics and Epidemiology, National Cancer Institute, Bethesda, MD 20892, USA
    Ann Hum Genet 64:443-53. 2000
    ..When the minimal correlation is less than 0.5, an alternate robust procedure is proposed. The methods apply to combining data from sibships of different sizes...
  24. ncbi request reprint Secondary leukemia or myelodysplastic syndrome after treatment with epipodophyllotoxins
    M A Smith
    National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 17:569-77. 1999
    ..The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) has developed a monitoring plan to obtain reliable estimates of the risk of secondary leukemia after epipodophyllotoxin treatment...
  25. 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
    ....
  26. 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...
  27. 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...
  28. 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
    ....
  29. 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...
  30. 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...
  31. 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
    ....
  32. 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
    ....
  33. ncbi request reprint Methods for assessing reproducibility of clustering patterns observed in analyses of microarray data
    Lisa M McShane
    National Cancer Institute, Biometric Research Branch, DCTD, NIH, Bethesda, MD 20892 7434, USA
    Bioinformatics 18:1462-9. 2002
    ..However, clustering algorithms always detect clusters, even on random data, and it is easy to misinterpret the results without some objective measure of the reproducibility of the clusters...
  34. ncbi request reprint Genomic control for association studies under various genetic models
    Gang Zheng
    Office of Biostatistics Research, DECA, National Heart, Lung and Blood Institute, 6701 Rockledge Drive, MSC 7938, Bethesda, Maryland 20892 7938, USA
    Biometrics 61:186-92. 2005
    ....
  35. 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...
  36. 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
    ....
  37. pmc Robust genomic control for association studies
    Gang Zheng
    Office of Biostatistics Research, Division of Epidemiology and Clinical Applications, National Heart, Lung and Blood Institute, Bethesda, MD 20892, USA
    Am J Hum Genet 78:350-6. 2006
    ..The properties of this robust genomic control test with 2 df are examined by simulation. This genomic control-adjusted 2-df test has control of type I error and achieves reasonable power, relative to the optimal tests for each model...
  38. 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...
  39. 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...
  40. ncbi request reprint Efficiency robust tests for mapping quantitative trait loci using extremely discordant sib pairs
    Boris Freidlin
    Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA
    Hum Hered 55:117-24. 2003
    ..The additional linkage information contained in the trait values can be incorporated by combining the Haseman-Elston regression method and a robust allele sharing test...
  41. 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...
  42. ncbi request reprint Trend tests for case-control studies of genetic markers: power, sample size and robustness
    B Freidlin
    Biometric Research Branch, National Cancer Institute, Rockville, MD 20892, USA
    Hum Hered 53:146-52. 2002
    ..Simulation results of the robustness of these two tests indicate that the more computationally involved MAX test is preferable...
  43. pmc Clustering of non-major histocompatibility complex susceptibility candidate loci in human autoimmune diseases
    K G Becker
    Cancer Genetics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, USA
    Proc Natl Acad Sci U S A 95:9979-84. 1998
    ..This nonrandom clustering supports a hypothesis that, in some cases, clinically distinct autoimmune diseases may be controlled by a common set of susceptibility genes...
  44. ncbi request reprint Trends in reported incidence of primary malignant brain tumors in children in the United States
    M A Smith
    Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA
    J Natl Cancer Inst 90:1269-77. 1998
    ....
  45. ncbi request reprint Second malignancies as a consequence of nucleoside analog therapy for chronic lymphoid leukemias
    B D Cheson
    The Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    J Clin Oncol 17:2454-60. 1999
    ..The purpose of the present study was to assess the frequency of second tumors in patients with CLL who are treated with fludarabine and in patients with HCL who are treated with DCF and CdA...
  46. ncbi request reprint Twenty-five years of clinical research for patients with limited-stage small cell lung carcinoma in North America
    Pasi A Janne
    Lowe Center for Thoracic Oncology, Department of Adult Oncology, Dana Farber Cancer Institute, Boston, Massachusetts 02115, USA
    Cancer 95:1528-38. 2002
    ..To determine the changes in clinical trials and outcomes of patients with limited-stage small cell lung carcinoma (SCLC) treated on Phase III randomized trials initiated in North America between 1972 and 1992...
  47. ncbi request reprint Data monitoring and large apparent treatment effects
    Edward L Korn
    Control Clin Trials 25:67-9; author reply 71-2. 2004
  48. ncbi request reprint A testing procedure for survival data with few responders
    Boris Freidlin
    Stat Med 23:1818-23. 2004
  49. ncbi request reprint Multinomial phase II trial designs
    Boris Freidlin
    J Clin Oncol 20:599. 2002
  50. 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...
  51. ncbi request reprint A note on appropriate use of statistical tests of mutation rates from ordered groups
    Joseph L Gastwirth
    Department of Statistics, George Washington University, Washington, DC 20052, USA
    Genet Test 8:437-40. 2004
    ..In particular, the p value of the trend test on their data is noticeably lower (0.003) than 0.012 found by the standard test, providing stronger evidence for a relationship between allele frequency and Polish descent...
  52. ncbi request reprint Erythropoietin to treat anaemia in patients with head and neck cancer
    Boris Freidlin
    Lancet 363:81; author reply 81-2. 2004