Research Topics
| Vance W BergerSummaryAffiliation: National Institutes of Health Country: USA Publications
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Detail Information
Publications
Improving the information content of categorical clinical trial endpointsVance W Berger
Biometry Research Group, National Cancer Institute, Bethesda, MD 20892 7354, USA
Control Clin Trials 23:502-14. 2002..We also point out that using composite endpoints allows sponsors the most discretion in selecting their primary between-group statistical analysis. We illustrate these ideas with examples from a variety of therapeutic areas...- On improving research methodology in clinical trialsVance W Berger
National Cancer Institute, University of Maryland, Baltimore, MD, USA
Stat Methods Med Res 17:231-42. 2008.... - Nonparametric adjustment techniques for binary covariatesVance W Berger
National Cancer Institute, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354, USA
Biom J 47:199-205. 2005..Each of these approaches is nonparametric and exact, and so it is the precise reason for adjusting that should dictate which would be used in any given situation... - Quantifying the magnitude of baseline covariate imbalances resulting from selection bias in randomized clinical trialsVance W Berger
Biometry Research Group, National Cancer Institute, Executive Plaza North, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354, USA
Biom J 47:119-27; discussion 128-39. 2005..We find that a binary covariate can, on average, be up to 50% unbalanced by third-order selection bias... - Refining the assessment of the sensitivity and specificity of diagnostic tests, with applications to prostate cancer screening and non-small cell lung cancer stagingVance W Berger
Biometry Research Group, National Cancer Institute/NIH, Executive Plaza North, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892-7354, USA
Rev Panam Salud Publica 18:64-70. 2005 - Analysis of trichotomous pharmaceutical endpointsVance W Berger
Biometry Research Group, National Cancer Institute, University of Maryland, Baltimore County, Maryland, USA
J Biopharm Stat 15:739-45. 2005..The purpose of this paper is to fill this gap by offering an objective approach for parameter selection, and to provide real data examples to illustrate the use of this objective approach... - The reverse propensity score to detect selection bias and correct for baseline imbalancesVance W Berger
National Cancer Institute, EPN, Bethesda, MD 20892 7354, USA
Stat Med 24:2777-87. 2005..We demonstrate how the reverse propensity score allows for both detection of and correction for selection bias, or systematic baseline imbalances... 
Intent-to-randomize corrections for missing data resulting from run-in selection bias in clinical trials for chronic conditionsVance W Berger
National Cancer Institute, Bethesda, Maryland, USA
J Biopharm Stat 21:263-70. 2011..We propose specific imputation methods for doing so...- Direct effect on validity of response run-in selection in clinical trialsVance W Berger
National Cancer Institute, Bethesda, MD 20892, USA
Control Clin Trials 24:156-66. 2003.... - On the generation and ownership of alpha in medical studiesVance W Berger
National Cancer Institute, University of Maryland Baltimore County, Biometry Research Group, Executive Plaza North, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354, USA
Control Clin Trials 25:613-9. 2004..05 to work with. We will address these inconsistencies, and ask more generally where alpha comes from, how it can be generated, and under what conditions it should be one-tailed or two-tailed... - Ensuring the comparability of comparison groups: is randomization enough?Vance W Berger
National Cancer Institute, EPN, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354, USA
Control Clin Trials 25:515-24. 2004..Nevertheless, there have been a few published reports that contain descriptions of either this type of selection bias or indicators that it may have occurred... - A note on the evaluation of BoNTA trial qualityVance W Berger
Biometry Research Group, National Cancer Institute, Executive Plaza North, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD, 20892 7354, USA
Inflammopharmacology 19:243-4. 2011..1, which they interpret as a testimony of the high quality of the studies included. Unfortunately, we cannot share the author's enthusiasm, as a perfect Jadad score of 5 is no guarantee that a study is of good quality... - Minimizing predictability while retaining balance through the use of less restrictive randomization proceduresVance W Berger
National Cancer Institute, EPN, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354, USA
Stat Med 22:3017-28. 2003..This feature makes the maximal procedure more resistant to selection bias than the randomized block procedure is... - The analysis of stratified 2 x 2 contingency tablesVance W Berger
University of Maryland Baltimore County and National Cancer Institute, Executive Plaza North, Suite 3131, Bethesda, MD 20892 7354, USA
Biom J 48:992-1007. 2006..We develop novel tests that are analogous to the Smirnov, modified Smirnov, convex hull, and adaptive tests that have been proposed for ordered categorical data... - Does the Prentice criterion validate surrogate endpoints?Vance W Berger
Biometry Research Group, National Cancer Institute at University of Maryland Baltimore County, National National Institutes of Health
Stat Med 23:1571-8. 2004.... 
A general framework for the evaluation of clinical trial qualityVance W Berger
National Institutes of Health National Cancer Institute, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354 USA
Rev Recent Clin Trials 4:79-88. 2009..We will demonstrate that current evaluations fall well short of these ideals...- Evaluating research training outcomes: experience from the cancer prevention fellowship program at the National Cancer InstituteGraca M Dores
Office of Preventive Oncology, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20892 7361, USA
Acad Med 81:535-41. 2006.... - Sensitivity designs for preventing bias replication in randomized clinical trialsVance W Berger
NIH, Bethesda, MD 20892 7354, USA
Stat Methods Med Res 19:415-24. 2010..This of course makes the attribution of the results to the treatments much more plausible and makes the findings much more robust to violations of assumptions... - When can a clinical trial be called 'randomized'?Vance W Berger
National Cancer Institute, EPN, Suite 3131, 6130 Executive Boulevard, MSC 7354, Bethesda, MD 20892 7354, USA
Vaccine 21:468-72. 2003..After reviewing the benefits of randomization, paying particular attention to the specific aspects of randomization that confer each benefit, we will explore the issue of what constitutes a randomized study... - Opposing systematic reviews: the effects of two quality rating instruments on evidence regarding t'ai chi and bone mineral density in postmenopausal womenSunny Y Alperson
National Institute of Nursing Research, and NIH Clinical Center, National Institutes of Health, 10 Center Drive, Bethesda, MD 20892, USA
J Altern Complement Med 17:389-95. 2011..The aim is to examine how chosen quality rating instruments can impact systematic reviews of TC literature... - A review of methods for ensuring the comparability of comparison groups in randomized clinical trialsVance W Berger
National Cancer Institute, Biometry Research Group, Bethesda, MD 20892 7354, USA
Rev Recent Clin Trials 1:81-6. 2006.... - What does biostatistics mean to usVance W Berger
National Cancer Institute Bethesda, MD, USA
Mens Sana Monogr 4:89-103. 2006.... - The Decameron of poor researchVance W Berger
Biometry Research Group, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
BMJ 329:1436-40. 2004 - Adjusting for observable selection bias in block randomized trialsAnastasia Ivanova
Department of Biostatistics, The University of North Carolina at Chapel Hill, NC 27599, USA
Stat Med 24:1537-46. 2005..The method allows not only testing for the presence of observable selection bias, but also testing for a difference in treatment effects, adjusting for possible selection bias... - Misguided precedent is not a reason to use permuted blocksVance W Berger
Headache 46:1210-2. 2006 - Varying the block size does not conceal the allocationVance W Berger
J Crit Care 21:229; author reply 229-30. 2006 - Response to Klassen et al: Missing data should be more heartily penalizedVance W Berger
J Clin Epidemiol 59:759-60. 2006 - Critical appraisal of individual trials?Vance W Berger
Am J Gastroenterol 101:1156-7; author reply 1157. 2006 - Preventing fungal infections in chronic granulomatous diseaseVance W Berger
N Engl J Med 349:1190-1; author reply 1190-1. 2003 - Do not use blocked randomizationVance W Berger
Headache 46:343; author reply 343-5. 2006