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p-Values and Replicability: A Commentary on "The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations".
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- Statistics in Biopharmaceutical Research, 2021, v. 13, n. 1, p. 36, doi. 10.1080/19466315.2020.1807404
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Statistical Considerations for Cardiovascular Outcome Trials in Patients with Type 2 Diabetes Mellitus.
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- Statistics in Biopharmaceutical Research, 2017, v. 9, n. 4, p. 347, doi. 10.1080/19466315.2017.1280411
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- Article
Integrated Data Analysis for Assessing Treatment Effect through Combining Information from All Sources.
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- Statistics in Biopharmaceutical Research, 2017, v. 9, n. 1, p. 52, doi. 10.1080/19466315.2016.1197150
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Practical Analysis and Visualization Tools for Benefit-Risk Assessment in Drug Development: A Review of Recent FDA Advisory Committee Meeting Packages.
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- Statistics in Biopharmaceutical Research, 2016, v. 8, n. 4, p. 409, doi. 10.1080/19466315.2016.1231077
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Considerations on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment of Medical Product.
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- Statistics in Biopharmaceutical Research, 2016, v. 8, n. 4, p. 417, doi. 10.1080/19466315.2016.1234974
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- Article
Perspective: Multiplicity and Subgroups in the Context of Benefit–Risk Assessment.
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- Statistics in Biopharmaceutical Research, 2016, v. 8, n. 4, p. 404, doi. 10.1080/19466315.2016.1226945
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Selecting and Integrating Data Sources in Benefit–Risk Assessment: Considerations and Future Directions.
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- Statistics in Biopharmaceutical Research, 2016, v. 8, n. 4, p. 394, doi. 10.1080/19466315.2016.1225596
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- Article
Evaluation and Review of Strategies to Assess Cardiovascular Risk in Clinical Trials in Patients with Type 2 Diabetes Mellitus.
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- Statistics in Biopharmaceutical Research, 2015, v. 7, n. 4, p. 253, doi. 10.1080/19466315.2015.1077724
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- Article
The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations.
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- Statistics in Biopharmaceutical Research, 2015, v. 7, n. 3, p. 174, doi. 10.1080/19466315.2015.1043395
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- Article
A Revisit of Sample Size Decisions in Confirmatory Trials.
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- Statistics in Biopharmaceutical Research, 2010, v. 2, n. 2, p. 239, doi. 10.1198/sbr.2009.0073
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Statisticians in the Pharmaceutical Industry: The 21st Century.
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- Statistics in Biopharmaceutical Research, 2010, v. 2, n. 2, p. 145, doi. 10.1198/sbr.2009.0036
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- Article
Celebrating the 175th Anniversary of ASA.
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- American Statistician, 2015, v. 69, n. 2, p. 64, doi. 10.1080/00031305.2015.1028765
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- Article
The Practice of Pre-Marketing Safety Assessment in Drug Development.
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- Journal of Biopharmaceutical Statistics, 2013, v. 23, n. 1, p. 3, doi. 10.1080/10543406.2013.736805
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Designing Studies to Find Early Signals of Efficacy.
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- Journal of Biopharmaceutical Statistics, 2012, v. 22, n. 6, p. 1097, doi. 10.1080/10543406.2011.570466
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Viewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group.
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- Journal of Biopharmaceutical Statistics, 2010, v. 20, n. 6, p. 1115, doi. 10.1080/10543406.2010.514452
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FDA Draft Guidance on Adaptive Design Clinical Trials: Pfizer's Perspective.
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- Journal of Biopharmaceutical Statistics, 2010, v. 20, n. 6, p. 1143, doi. 10.1080/10543406.2010.514456
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- Article
Determining a Minimum Clinically Important Difference Between Treatments for a Patient-Reported Outcome.
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- Journal of Biopharmaceutical Statistics, 2010, v. 20, n. 5, p. 1043, doi. 10.1080/10543400903315757
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Discussion of “Some Controversial Multiple Testing Problems in Regulatory Applications”.
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- Journal of Biopharmaceutical Statistics, 2009, v. 19, n. 1, p. 14, doi. 10.1080/10543400802541719
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Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group.
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- Journal of Biopharmaceutical Statistics, 2006, v. 16, n. 3, p. 275, doi. 10.1080/10543400600614742
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Rejoinder.
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- Journal of Biopharmaceutical Statistics, 2006, v. 16, n. 3, p. 311, doi. 10.1080/10543400600614775
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An Industry Survey on Current Practices in the Design and Analysis of Active Control Studies.
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- Journal of Biopharmaceutical Statistics, 2004, v. 14, n. 2, p. 349, doi. 10.1081/BIP-120037185
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Adaptivity in drug discovery and development.
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- Drug Development Research, 2009, v. 70, n. 3, p. 169, doi. 10.1002/ddr.20285
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Implementation of AMNOG: An industry perspective.
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- Biometrical Journal, 2016, v. 58, n. 1, p. 76, doi. 10.1002/bimj.201300256
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A Cautionary Note on Design Implications when the Primary Analysis is a Stratified Analysis of a Binary Endpoint.
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- Biometrical Journal, 2006, v. 48, n. 6, p. 978, doi. 10.1002/bimj.200610291
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- Article
The Acute Stroke Therapy by Inhibition of Neutrophils study – Key features and impact.
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- Pharmaceutical Statistics, 2022, v. 21, n. 4, p. 720, doi. 10.1002/pst.2218
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Lessons from meta‐analyses of randomized clinical trials for analysis of distributed networks of observational databases.
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- Pharmaceutical Statistics, 2019, v. 18, n. 1, p. 65, doi. 10.1002/pst.1908
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A comparison of five approaches to decision-making for a first clinical trial of efficacy.
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- Pharmaceutical Statistics, 2017, v. 16, n. 1, p. 37, doi. 10.1002/pst.1775
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The shrinking or disappearing observed treatment effect.
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- Pharmaceutical Statistics, 2014, v. 13, n. 5, p. 277, doi. 10.1002/pst.1633
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Subgroup analyses in cost-effectiveness analyses to support health technology assessments.
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- Pharmaceutical Statistics, 2014, v. 13, n. 4, p. 265, doi. 10.1002/pst.1626
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Strong control over multiple endpoints: are we adding value to the assessment of medicines?
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- Pharmaceutical Statistics, 2013, v. 12, n. 4, p. 189, doi. 10.1002/pst.1574
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Subgroup analyses of clinical effectiveness to support health technology assessments.
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- Pharmaceutical Statistics, 2011, v. 10, n. 6, p. 532, doi. 10.1002/pst.531
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The role of the minimum clinically important difference and its impact on designing a trial.
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- Pharmaceutical Statistics, 2011, v. 10, n. 3, p. 250, doi. 10.1002/pst.459
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Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies.
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- Pharmaceutical Statistics, 2011, v. 10, n. 1, p. 3, doi. 10.1002/pst.397
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What should be the role of homogeneity testing in adaptive trials?
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- Pharmaceutical Statistics, 2009, v. 8, n. 1, p. 1, doi. 10.1002/pst.342
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A case study comparing a randomized withdrawal trial and a double-blind long-term trial for assessing the long-term efficacy of an antidepressant.
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- Pharmaceutical Statistics, 2007, v. 6, n. 1, p. 9, doi. 10.1002/pst.234
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Sample size and the probability of a successful trial.
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- Pharmaceutical Statistics, 2006, v. 5, n. 4, p. 305, doi. 10.1002/pst.232
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Editorial.
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- Pharmaceutical Statistics, 2005, v. 4, n. 4, p. 231, doi. 10.1002/pst.196
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Four case studies to highlight some opportunities and challenges in developing anti-bacterial and anti-fungal agents.
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- Pharmaceutical Statistics, 2005, v. 4, n. 4, p. 253, doi. 10.1002/pst.184
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Editorial.
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- Pharmaceutical Statistics, 2005, v. 4, n. 3, p. 153, doi. 10.1002/pst.187
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Editorial.
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- Pharmaceutical Statistics, 2005, v. 4, n. 2, p. 85, doi. 10.1002/pst.171
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Editorial.
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- Pharmaceutical Statistics, 2005, v. 4, n. 1, p. 1, doi. 10.1002/pst.163
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Editorial.
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- Pharmaceutical Statistics, 2004, v. 3, n. 4, p. 235, doi. 10.1002/pst.150
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Editorial.
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- Pharmaceutical Statistics, 2004, v. 3, n. 3, p. 155, doi. 10.1002/pst.134
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Seize the opportunities.
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- Pharmaceutical Statistics, 2004, v. 3, n. 3, p. 157, doi. 10.1002/pst.133
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Editorial.
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- Pharmaceutical Statistics, 2004, v. 3, n. 2, p. 75, doi. 10.1002/pst.122
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Editorial.
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- Pharmaceutical Statistics, 2004, v. 3, n. 1, p. 1, doi. 10.1002/pst.102
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Type I error and power in trials with one interim futility analysis.
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- Pharmaceutical Statistics, 2004, v. 3, n. 1, p. 51, doi. 10.1002/pst.93
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Editorial.
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- Pharmaceutical Statistics, 2003, v. 2, n. 4, p. 237, doi. 10.1002/pst.94
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Editorial.
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- Pharmaceutical Statistics, 2003, v. 2, n. 3, p. 159, doi. 10.1002/pst.79
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Editorial.
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- Pharmaceutical Statistics, 2003, v. 2, n. 1, p. 1, doi. 10.1002/pst.46
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- Article