A Lawrence Gould

Summary

Affiliation: Merck Research Laboratories
Country: USA

Publications

  1. doi request reprint Detecting potential safety issues in large clinical or observational trials by Bayesian screening when event counts arise from poisson distributions
    A Lawrence Gould
    Merck Research Laboratories, Merck and Co, Inc, North Wales, PA 19038, USA
    J Biopharm Stat 23:829-47. 2013
  2. ncbi request reprint Cholesterol reduction yields clinical benefits: meta-analysis including recent trials
    A Lawrence Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    Clin Ther 29:778-94. 2007
  3. ncbi request reprint Timing of futility analyses for 'proof of concept' trials
    A Lawrence Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    Stat Med 24:1815-35. 2005
  4. doi request reprint Effects of sources of variability on sample sizes required for RCTs, applied to trials of lipid-altering therapies on carotid artery intima-media thickness
    A Lawrence Gould
    Merck Research Laboratories, Rahway, NJ, USA
    Clin Trials 6:305-19. 2009
  5. ncbi request reprint Practical pharmacovigilance analysis strategies
    A Lawrence Gould
    Merck Research Laboratories, BL3 2 West Point, PA 19486, USA
    Pharmacoepidemiol Drug Saf 12:559-74. 2003
  6. doi request reprint 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
  7. doi request reprint Generating and confirming hypotheses
    A Lawrence Gould
    Merck Research Laboratories, North Wales, PA 19454, USA
    Pharmacoepidemiol Drug Saf 19:533-6. 2010
  8. ncbi request reprint Substantial evidence of effect
    A Lawrence Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    J Biopharm Stat 12:53-77. 2002
  9. ncbi request reprint Sample size re-estimation: recent developments and practical considerations
    A L Gould
    Merck Research Laboratories, West Point, PA 19486, U S A
    Stat Med 20:2625-43. 2001
  10. ncbi request reprint A practical approach for evaluating population and individual bioequivalence
    A L Gould
    Merck Research Laboratories, West Point, PA, USA
    Stat Med 19:2721-40. 2000

Collaborators

Detail Information

Publications21

  1. doi request reprint Detecting potential safety issues in large clinical or observational trials by Bayesian screening when event counts arise from poisson distributions
    A Lawrence Gould
    Merck Research Laboratories, Merck and Co, Inc, North Wales, PA 19038, USA
    J Biopharm Stat 23:829-47. 2013
    ..Supplemental materials are available for this article. Go to the publisher's online edition of Journal of Biopharmaceutical Statistics for the following free supplemental resource: Appendix R: Code for calculations.]. ..
  2. ncbi request reprint Cholesterol reduction yields clinical benefits: meta-analysis including recent trials
    A 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...
  3. ncbi request reprint Timing of futility analyses for 'proof of concept' trials
    A Lawrence Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    Stat Med 24:1815-35. 2005
    ....
  4. doi request reprint Effects of sources of variability on sample sizes required for RCTs, applied to trials of lipid-altering therapies on carotid artery intima-media thickness
    A Lawrence Gould
    Merck Research Laboratories, Rahway, NJ, USA
    Clin Trials 6:305-19. 2009
    ....
  5. ncbi request reprint Practical pharmacovigilance analysis strategies
    A 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...
  6. doi request reprint 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
    ....
  7. doi request reprint Generating and confirming hypotheses
    A 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'...
  8. ncbi request reprint Substantial evidence of effect
    A Lawrence Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    J Biopharm Stat 12:53-77. 2002
    ....
  9. ncbi request reprint Sample size re-estimation: recent developments and practical considerations
    A 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...
  10. ncbi request reprint A practical approach for evaluating population and individual bioequivalence
    A 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...
  11. ncbi request reprint Cholesterol reduction yields clinical benefit: impact of statin trials
    A L Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    Circulation 97:946-52. 1998
    ....
  12. ncbi request reprint An evaluation of computer-aided disproportionality analysis for post-marketing signal detection
    H 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...
  13. ncbi request reprint 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
    ....
  14. ncbi request reprint Bayesian analysis of multicentre trial outcomes
    A 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...
  15. ncbi request reprint Treatment comparisons for a partially categorical outcome applied to a biomarker with assay limit
    Y 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...
  16. ncbi request reprint Effect of within-household reinfestation on design sensitivity
    Cong 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...
  17. ncbi request reprint Comparison of alternative strategies for analysis of longitudinal trials with dropouts
    Guanghan Liu
    Merck Research Laboratories, Pennsylvania, USA
    J Biopharm Stat 12:207-26. 2002
    ....
  18. ncbi request reprint A predictive Bayesian approach to the design and analysis of bridging studies
    A 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.]...
  19. ncbi request reprint Accounting for multiplicity in the evaluation of "signals" obtained by data mining from spontaneous report adverse event databases
    A 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...
  20. doi request reprint Detecting potential safety issues in clinical trials by Bayesian screening
    A 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...
  21. ncbi request reprint Cholesterol reduction yields clinical benefit. A new look at old data
    A L Gould
    Merck Research Laboratories, West Point, PA 19486, USA
    Circulation 91:2274-82. 1995
    ....