B S Kramer

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. pmc Getting it right: being smarter about clinical trials
    Barnett S Kramer
    National Institutes of Health, Rockville, Maryland, USA
    PLoS Med 3:e144. 2006
  2. pmc The transitive fallacy for randomized trials: if A bests B and B bests C in separate trials, is A better than C?
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute
    BMC Med Res Methodol 2:13. 2002
  3. pmc Randomized trials, generalizability, and meta-analysis: graphical insights for binary outcomes
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, USA
    BMC Med Res Methodol 3:10. 2003
  4. pmc Estimating the cumulative risk of false positive cancer screenings
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA
    BMC Med Res Methodol 3:11. 2003
  5. pmc The fallacy of enrolling only high-risk subjects in cancer prevention trials: is there a "free lunch"?
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA
    BMC Med Res Methodol 4:24. 2004
  6. pmc Comparing breast cancer mortality rates before-and-after a change in availability of screening in different regions: extension of the paired availability design
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    BMC Med Res Methodol 4:12. 2004
  7. pmc Using observational data to estimate an upper bound on the reduction in cancer mortality due to periodic screening
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, USA
    BMC Med Res Methodol 3:4. 2003
  8. pmc A perfect correlate does not a surrogate make
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, USA
    BMC Med Res Methodol 3:16. 2003
  9. pmc Statistical issues in randomized trials of cancer screening
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    BMC Med Res Methodol 2:11. 2002
  10. pmc Paradoxes in carcinogenesis: new opportunities for research directions
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    BMC Cancer 7:151. 2007

Detail Information

Publications51

  1. pmc Getting it right: being smarter about clinical trials
    Barnett S Kramer
    National Institutes of Health, Rockville, Maryland, USA
    PLoS Med 3:e144. 2006
  2. pmc The transitive fallacy for randomized trials: if A bests B and B bests C in separate trials, is A better than C?
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute
    BMC Med Res Methodol 2:13. 2002
    ..On its surface, this would appear to be a straightforward application of the transitive principle of logic...
  3. pmc Randomized trials, generalizability, and meta-analysis: graphical insights for binary outcomes
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, USA
    BMC Med Res Methodol 3:10. 2003
    ..the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?"..
  4. pmc Estimating the cumulative risk of false positive cancer screenings
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA
    BMC Med Res Methodol 3:11. 2003
    ..A previous approach to estimate the probability of at least one false positive in n screenings unrealistically assumed that the probability of dropout does not depend on prior false positives...
  5. pmc The fallacy of enrolling only high-risk subjects in cancer prevention trials: is there a "free lunch"?
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA
    BMC Med Res Methodol 4:24. 2004
    ..We critically investigate the plausibility of these assumptions...
  6. pmc Comparing breast cancer mortality rates before-and-after a change in availability of screening in different regions: extension of the paired availability design
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    BMC Med Res Methodol 4:12. 2004
    ..The original formulation involved short-term outcomes; the challenge here is accommodating long-term outcomes...
  7. pmc Using observational data to estimate an upper bound on the reduction in cancer mortality due to periodic screening
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, USA
    BMC Med Res Methodol 3:4. 2003
    ....
  8. pmc A perfect correlate does not a surrogate make
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, USA
    BMC Med Res Methodol 3:16. 2003
    ..We investigate this belief when the potential surrogate and unobserved true endpoints are perfectly correlated within each randomization group...
  9. pmc Statistical issues in randomized trials of cancer screening
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    BMC Med Res Methodol 2:11. 2002
    ..Although some of these issues have been discussed previously, we present important recent and new methodologies...
  10. pmc Paradoxes in carcinogenesis: new opportunities for research directions
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    BMC Cancer 7:151. 2007
    ..These paradoxical aspects offer opportunities for new research directions that should not be ignored...
  11. pmc Plausibility of stromal initiation of epithelial cancers without a mutation in the epithelium: a computer simulation of morphostats
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, USA
    BMC Cancer 9:89. 2009
    ..These disrupted interactions are hypothesized to be mediated by molecules, termed morphostats, which diffuse through the tissue to determine cell phenotype and maintain tissue architecture...
  12. pmc Identifying genes that contribute most to good classification in microarrays
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    BMC Bioinformatics 7:407. 2006
    ..Our strategy is to search for classification rules that perform well with few genes and, if they are found, identify genes that occur relatively frequently under multiple random validation (random splits into training and test samples)...
  13. pmc The paired availability design for historical controls
    S G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    BMC Med Res Methodol 1:9. 2001
    ..One alternative, an observational cohort study, can give biased results if it is not possible to adjust for all relevant risk factors...
  14. pmc Cumulative incidence of false-positive results in repeated, multimodal cancer screening
    Jennifer Miller Croswell
    Office of the Director, Office of Disease Prevention, National Institutes of Health, 6100 Executive Blvd, Suite 2B 03, Bethesda, MD 20892, USA
    Ann Fam Med 7:212-22. 2009
    ..We sought to determine the cumulative risk of a false-positive screening result and the resulting risk of a diagnostic procedure for an individual participating in a multimodal cancer screening program...
  15. ncbi request reprint Repeat prostate biopsy in the prostate, lung, colorectal and ovarian cancer screening trial
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, NIH, DHHS, Bethesda, MD, USA
    BJU Int 99:775-9. 2007
    ..To determine patterns of repeat prostate biopsy in a cohort of men undergoing prostate cancer screening who have a negative initial biopsy...
  16. ncbi request reprint Prostate-specific antigen velocity and prostate cancer gleason grade and stage
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland 20892, USA
    Cancer 109:1689-95. 2007
    ..The authors evaluated the relation between PSAV, biopsy Gleason score, and pathologic stage in men who were enrolled in a prostate cancer screening trial...
  17. ncbi request reprint Prostate biopsy following a positive screen in the prostate, lung, colorectal and ovarian cancer screening trial
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA
    J Urol 173:746-50; discussion 750-1. 2005
    ..Followup of positive screens in PLCO is done by subject personal physicians and it is outside of trial control. We describe the pattern of prostate biopsy in men with positive screens in PLCO...
  18. ncbi request reprint Randomized trials for the real world: making as few and as reasonable assumptions as possible
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    Stat Methods Med Res 17:243-52. 2008
    ....
  19. doi request reprint Estimating the cumulative risk of a false-positive under a regimen involving various types of cancer screening tests
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd MSC 7354, Bethesda, MD 20892 7354, USA
    J Med Screen 15:18-22. 2008
    ..Previous methods for estimating cumulative risk of FPs with a single type of test are not directly applicable, so a new approach was developed...
  20. pmc Using microarrays to study the microenvironment in tumor biology: the crucial role of statistics
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    Semin Cancer Biol 18:305-10. 2008
    ..Using these examples we critically discuss three types of analyses: differential gene expression, cluster analysis, and class prediction. We also discuss design issues...
  21. pmc Principles of cancer screening: lessons from history and study design issues
    Jennifer M Croswell
    Office of Medical Applications of Research, National Institutes of Health, Bethesda, MD 20892, USA
    Semin Oncol 37:202-15. 2010
    ....
  22. doi request reprint Assessing contamination and compliance in the prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
    Clin Trials 7:303-11. 2010
    ..An issue of concern was the substantial level of 'contamination', or use of PSA and DRE in control arm men...
  23. doi request reprint Cancer screening: the clash of science and intuition
    Barnett S Kramer
    Office of Disease Prevention, Office of the Director, National Institutes of Health, Bethesda, Maryland 20892, USA
    Annu Rev Med 60:125-37. 2009
    ..This article explains these biases and other common confounders in cancer screening. The most direct and reliable way to avoid being led astray by intuitions is through the use of randomized controlled trials...
  24. pmc Early reporting for cancer screening trials
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    J Med Screen 15:122-9. 2008
    ....
  25. doi request reprint Clinical trial design and evidence-based outcomes in the study of liver diseases
    Jennifer M Croswell
    National Institutes of Health, Office of Disease Prevention, 6100 Executive Blvd, Suite 2B 03 Bethesda, MD 20892, USA
    J Hepatol 50:817-26. 2009
    ....
  26. doi request reprint Cumulative incidence of false-positive test results in lung cancer screening: a randomized trial
    Jennifer M Croswell
    National Institutes of Health, National Cancer Institute, Bethesda, and Information Management Services, Rockville, Maryland 20892, USA
    Ann Intern Med 152:505-12, W176-80. 2010
    ..However, screening exposes healthy persons to potential harms, and cumulative false-positive rates for low-dose CT have never been formally reported...
  27. pmc Transparency and reproducibility in data analysis: the Prostate Cancer Prevention Trial
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, 6130 Executive Boulevard, Bethesda, MD 20892 7354, USA
    Biostatistics 11:413-8. 2010
    ..With such an important result at stake, a transparent analysis was important...
  28. pmc National Children's Study: update in 2010
    Steven Hirschfeld
    Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA
    Mt Sinai J Med 78:119-25. 2011
    ..Three different recruitment strategies are under evaluation to determine what approach to use for the Main Study. The organization of National Children's Study operations is currently based on a new decentralized business model...
  29. ncbi request reprint Development tracks for cancer prevention markers
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    Dis Markers 20:97-102. 2004
    ..We provide a general framework for describing various roles for biomarkers in cancer prevention research (early detection, surrogate endpoint, and cohort identification for primary prevention) and the phases in their evaluation...
  30. ncbi request reprint Simple adjustments for randomized trials with nonrandomly missing or censored outcomes arising from informative covariates
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    Biostatistics 7:29-40. 2006
    ..We discuss the computations for univariate, survival, and longitudinal outcomes, and present an application involving a randomized study of dual versus triple combinations of HIV-1 reverse transcriptase inhibitors...
  31. ncbi request reprint Simple maximum likelihood estimates of efficacy in randomized trials and before-and-after studies, with implications for meta-analysis
    Stuart G Baker
    Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892 7354, USA
    Stat Methods Med Res 14:349-67. 2005
    ..Particular attention is paid to estimating efficacy in meta-analysis, where the interpretation is much more straightforward than with intent-to-treat analyses...
  32. ncbi request reprint The science of early detection
    Barnett S Kramer
    National Institutes of Health, Department of Health and Human Services, Office of Disease Prevention, OD, 6100 Executive Boulevard, Room 2B03, Bethesda, MD 20892 2802, USA
    Urol Oncol 22:344-7. 2004
    ..This article will discuss those biases, review methods to avoid them, and provide useful resources to the clinician or health scientist...
  33. ncbi request reprint Diagnostic procedures after a positive spiral computed tomography lung carcinoma screen
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA
    Cancer 103:157-63. 2005
    ....
  34. pmc Markers for early detection of cancer: statistical guidelines for nested case-control studies
    Stuart G Baker
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
    BMC Med Res Methodol 2:4. 2002
    ..This has spurred nested case-control studies that involve testing some specimens for various markers that might predict cancer. Until now there has been little guidance in statistical design and analysis of these studies...
  35. ncbi request reprint Evaluating markers for the early detection of cancer: overview of study designs and methods
    Stuart G Baker
    National Institutes of Health, Bethesda, MD, USA
    Clin Trials 3:43-56. 2006
    ..New developments both in the biologic and statistical realms are providing increasing opportunities for evaluation of markers for both early detection and diagnosis of cancer...
  36. ncbi request reprint Reported family history of cancer in the prostate, lung, colorectal, and ovarian cancer screening trial
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892, USA
    Am J Epidemiol 157:792-9. 2003
    ..7. Liver, bone, stomach, and brain cancer had greater-than-average reported:expected ratios, while lymphoma, bladder cancer, melanoma, and testicular cancer had lower-than-average ratios...
  37. ncbi request reprint Prostate volume and prostate-specific antigen levels in men enrolled in a large screening trial
    Paul F Pinsky
    Division of Cancer Prevention, National Cancer Institute, Bethedsa, Maryland, USA
    Urology 68:352-6. 2006
    ..Here we examine the relationship between prostate volume and PSA level in a large, geographically diverse sample of men undergoing prostate cancer screening...
  38. ncbi request reprint Estimating the cumulative risk of a false-positive test in a repeated screening program
    Jian Lun Xu
    Biometry Research Group, National Cancer Institute, Bethesda, Maryland 20892 7354, USA
    Biometrics 60:651-60. 2004
    ..The extension of the new model by incorporating covariate information is also considered. We apply our testing method and the new model to data from the breast cancer screening trial of the Health Insurance Plan of Greater New York...
  39. pmc Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline
    Barnett S Kramer
    National Institutes of Health, Bethesda, MD, USA
    J Clin Oncol 27:1502-16. 2009
    ..No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI...
  40. doi request reprint Use of 5alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline
    Barnett S Kramer
    National Institutes of Health, Bethesda, MD, USA
    J Urol 181:1642-57. 2009
    ..To develop an evidence-based guideline on the use of 5-alpha-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention...
  41. ncbi request reprint Cancer prevention and the American Society of Clinical Oncology
    Scott M Lippman
    The University of Texas M D Anderson Cancer Center, Houston, USA
    J Clin Oncol 22:3848-51. 2004
  42. ncbi request reprint General keynote: cancer screening: translation of principles into practice
    Barnett S Kramer
    Division of Cancer Prevention, National Cancer Institute, USA
    Gynecol Oncol 88:S71-4; discussion S80-3. 2003
  43. ncbi request reprint Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology
    Robert F Ozols
    American Society of Clinical Oncology, Alexandria, VA 22314, USA
    J Clin Oncol 25:146-62. 2007
    ..This report demonstrates the essential role of clinical cancer research in finding new and better ways to treat, diagnose, and prevent a group of diseases that strike half of men and one-third of women in the United States...
  44. ncbi request reprint Final results of the Lung Screening Study, a randomized feasibility study of spiral CT versus chest X-ray screening for lung cancer
    John K Gohagan
    Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd, EPN 3064, Bethesda, MD 20892, USA
    Lung Cancer 47:9-15. 2005
    ..A total of 16 stage III-IV cancers were observed in the LDCT arm versus nine in the CXR arm. The LSS has established the feasibility of a RCT comparing annual spiral CT to chest X-ray for lung cancer screening...
  45. ncbi request reprint Cancer screening in theory and in practice
    Otis W Brawley
    Georgia Cancer Center, Glenn Memorial Bldg, 69 Jesse Hill Jr Drive, Atlanta, GA 30303, USA
    J Clin Oncol 23:293-300. 2005
    ..A screening test is done on asymptomatic individuals who receive the test principally because they are of the age or sex at risk for the cancer. A diagnostic test is done on an individual because of clinical suspicion of disease...
  46. ncbi request reprint Prostate Cancer Screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: findings from the initial screening round of a randomized trial
    Gerald L Andriole
    Division of Urologic Surgery, Washington University School of Medicine, St Louis, MO 63110, USA
    J Natl Cancer Inst 97:433-8. 2005
    ..We describe the population enrolled in the PLCO trial, their baseline PSA and DRE screening results, and diagnostic follow-up results during the first year of follow-up...
  47. ncbi request reprint Overstating the evidence for lung cancer screening: the International Early Lung Cancer Action Program (I-ELCAP) study
    H Gilbert Welch
    VA Outcomes Group, White River Junction VA Medical Center, 215 N Main St, VA Outcomes Group, 11B, White River Junction, VT 05009, USA
    Arch Intern Med 167:2289-95. 2007
    ....
  48. ncbi request reprint Prostate specific antigen changes as related to the initial prostate specific antigen: data from the prostate, lung, colorectal and ovarian cancer screening trial
    E David Crawford
    Department of Urologic Oncology, University of Colorado Health Sciences Center, Denver, Colorado, Washington, DC, USA
    J Urol 175:1286-90; discussion 1290. 2006
    ..A large fraction of screened men have low (less than 2 ng/ml) initial PSA. The yield over time of positive PSA screens (ie more than 4 ng/ml) in these men has not been well characterized in large cohorts in the United States...
  49. ncbi request reprint Screening for prostate cancer: current status and future prospects
    Nima Sharifi
    Medical Oncology Branch, National Cancer Institute, Bethesda, MD, USA
    Am J Med 120:743-5. 2007
  50. doi request reprint Design and endpoints of clinical trials in hepatocellular carcinoma
    Josep M Llovet
    HCC Translational Research Lab, Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic, CIBERehd, Institute for Biomedical Investigations August Pi Sunyer, Villarroel 170, 08036 Barcelona, Catalonia, Spain
    J Natl Cancer Inst 100:698-711. 2008
    ..These surrogate markers may help to enrich study populations and maximize the cost-benefit ratio of trial execution. Design and conduct of phase 3 trials should be coordinated by centers with appropriate expertise in HCC...
  51. ncbi request reprint Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology
    Julie Gralow
    American Society of Clinical Oncology, 1900 Duke St, Suite 200, Alexandria, VA 22314, USA
    J Clin Oncol 26:313-25. 2008
    ..I hope you find it useful. Sincerely, Nancy E. Davidson, MD President American Society of Clinical Oncology...