Research Topics
| A Lawrence GouldSummaryAffiliation: Merck Research Laboratories Country: USA Publications
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Detail Information
Publications
Effects of sources of variability on sample sizes required for RCTs, applied to trials of lipid-altering therapies on carotid artery intima-media thicknessA Lawrence Gould
Merck Research Laboratories, Rahway, NJ, USA
Clin Trials 6:305-19. 2009....
Timing of futility analyses for 'proof of concept' trialsA Lawrence Gould
Merck Research Laboratories, West Point, PA 19486, USA
Stat Med 24:1815-35. 2005....- A 1-step Bayesian predictive approach for evaluating in vitro in vivo correlation (IVIVC)A Lawrence Gould
Merck Research Laboratories, North Wales, PA 19454, USA
Biopharm Drug Dispos 30:366-88. 2009.... - Practical pharmacovigilance analysis strategiesA Lawrence Gould
Merck Research Laboratories, BL3 2 West Point, PA 19486, USA
Pharmacoepidemiol Drug Saf 12:559-74. 2003..To compare two recently proposed Bayesian methods for quantitative pharmacovigilance with respect to assumptions and results, and to describe some practical strategies for their use... - Cholesterol reduction yields clinical benefits: meta-analysis including recent trialsA Lawrence Gould
Merck Research Laboratories, West Point, PA 19486, USA
Clin Ther 29:778-94. 2007..Previous meta-analyses reported by Gould et al found significant decreases of 15% in the risk for coronary heart disease (CHD)-related mortality and 11 % in risk for all-cause mortality per decrease of 10% in total cholesterol (TC) level... - Substantial evidence of effectA Lawrence Gould
Merck Research Laboratories, West Point, PA 19486, USA
J Biopharm Stat 12:53-77. 2002.... - Sample size re-estimation: recent developments and practical considerationsA L Gould
Merck Research Laboratories, West Point, PA 19486, U S A
Stat Med 20:2625-43. 2001..In such cases, it may be better to estimate the sample size conservatively and introduce an interim efficacy evaluation... - A practical approach for evaluating population and individual bioequivalenceA L Gould
Merck Research Laboratories, West Point, PA, USA
Stat Med 19:2721-40. 2000..In the cases where the conclusions do not match, the new approach appears to be more consistent with the data... - Cholesterol reduction yields clinical benefit: impact of statin trialsA L Gould
Merck Research Laboratories, West Point, PA 19486, USA
Circulation 97:946-52. 1998.... - Generating and confirming hypothesesA Lawrence Gould
Merck Research Laboratories, North Wales, PA 19454, USA
Pharmacoepidemiol Drug Saf 19:533-6. 2010..Walker's assertion. The key conclusion is that what constitutes 'independent' data has to be considered carefully, and that hypothesis-generating and test data from the same data source generally can not be considered 'independent'... - An evaluation of computer-aided disproportionality analysis for post-marketing signal detectionH P Lehman
Merck and Co Inc, West Point, PA, USA
Clin Pharmacol Ther 82:173-80. 2007..DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods... - How practical are adaptive designs likely to be for confirmatory trials?A Lawrence Gould
Merck Research Laboratories, West Point, PA 19486, USA
Biom J 48:644-9; discussion 660-2. 2006.... - Treatment comparisons for a partially categorical outcome applied to a biomarker with assay limitY H Joshua Chen
Merck Research Laboratories, Blue Bell, PA 19422, USA
Stat Med 24:211-28. 2005..An example is used to illustrate this approach and a simulation study is used to compare this approach with other methods... - Effect of within-household reinfestation on design sensitivityCong Chen
Merck Research Laboratories, West Point, Pennsylvania 19486, USA
J Biopharm Stat 13:327-36. 2003..The results from the study were consistent with theoretical expectations. This seeming contradiction to the blocking principle demonstrates the need to check whether all conditions are met before applying standard design principles... - Comparison of alternative strategies for analysis of longitudinal trials with dropoutsGuanghan Liu
Merck Research Laboratories, Pennsylvania, USA
J Biopharm Stat 12:207-26. 2002.... - Bayesian analysis of multicentre trial outcomesA Lawrence Gould
Merck Research Laboratories, BL3 2, West Point, PA 19486, USA
Stat Methods Med Res 14:249-80. 2005..The Bayesian methods provided some insights useful for model checking and also provided a way to explore some important quantitative aspects about the magnitude of treatment effects... - A predictive Bayesian approach to the design and analysis of bridging studiesA Lawrence Gould
Merck Research Laboratories, Merck and Co, Inc, North Wales, PA 19454, USA
J Biopharm Stat 22:916-34. 2012..Supplemental materials are available for this article. Go to the Publisher's online edition of the Journal of Biopharmaceutical Statistics for the following free supplemental resource: Appendix 2: R code for Calculations.]... - Accounting for multiplicity in the evaluation of "signals" obtained by data mining from spontaneous report adverse event databasesA Lawrence Gould
Merck Sharp and Dohme Research Laboratories, West Point, PA 19486, USA
Biom J 49:151-65. 2007..The Bayesian approach appears to have attractive diagnostic properties in addition to being easy to interpret and implement computationally... - Detecting potential safety issues in clinical trials by Bayesian screeningA Lawrence Gould
Merck Research Laboratories, UG1D 88, 351 North Sumneytown Pike, North Wales, PA 19454, USA
Biom J 50:837-51. 2008..Application of the method to findings from a vaccine trial yield results similar to those found by methods using a false discovery rate argument and using a hierarchical Bayes approach... - Cholesterol reduction yields clinical benefit. A new look at old dataA L Gould
Merck Research Laboratories, West Point, PA 19486, USA
Circulation 91:2274-82. 1995....