​Presentations

• To FDA Division Directors on "Strengthening the interpretation of clinical trial data" Talk begins around the 1 hour, 13 min mark. https://collaboration.fda.gov/p3ekvx9g6zsc/ 

• Joint UCSF presentation on "Estimating benefit-risk, handling missing data, and a universal sample size formula for clinical trials" https://www.youtube.com/watch?v=LkcyvC9HhoA

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Publications by topic (solo and co-authored)

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 Trial Efficiency

• Improving the operational efficiency of Phase 2 and 3 trials. Trials, 2016. 

• Sponsor-unblinded Phase 1 trials: Challenging the double-blind paradigm. Drug Information Journal, 2010.

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Trial Design and Reporting​​

• A new way to address missing data in late-stage clinical trials. Contemporary Clinical Trials, 2024

• Variable duration trial as an alternative design for continuous endpoints. Pharmaceutical Statistics, 2024. 

• Improving the standards of reporting of clinical trial data.  Therapeutic Innovation and Regulatory Science, 2019.

• Non-inferiority vs superiority drug claims: the (not so) subtle distinction. Trials, 2017.

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Sample Size

• Sample size for a win ratio endpoint. Statistics in Medicine, 2022. (One of the 2022-23 top cited papers in the journal) 

• Size of trials. Book chapter, “Clinical Trials Handbook” Publisher: Wiley, 2009.

• Sample size for equivalence trials: A case study from a vaccine lot consistency trial. Statistics in Medicine, 2008.

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Robust Analysis

• Robust inference with multiple statistics via permutations. Pharmaceutical Statistics, 2013

• The potential for increased power from combining p-values testing the same hypothesis. Stat Methods Med Res, 2014.

• Robust inference for group sequential trials. Pharmaceutical Statistics, 2017.

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Randomization

• Randomized and random run order experiments. J. Stat Planning and Inference, 2005

• Detecting randomization restriction caused by factors. J. Stat Planning and Inference, 1999.

 

Covariates, Stratification and Blinding

• Some unexamined aspects of analysis of covariance in pretest-posttest studies. Biometrics, 2004. 

• Inference from blinded data in randomized clinical trials. Clinical Trials, 2013.

• The benefit of stratification in clinical trials reexamined. Statistics in Medicine, 2011.

• A method to estimate the variance of an endpoint from an on-going blinded trial. Statistics in Medicine, 2005.

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