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- Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials. Biometrical Journal 2010. 52:- .
- Adaptive patient enrichment designs in therapeutic trials. Biometrical Journal 2009. 51:358-374 .
- Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharmaceutical Statistics 2007. 6:227-244 .
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- Adapting the sample size planning of a phase III trial based on phase II data†. Pharmaceutical Statistics 2006. 5:- .
- Adapting the sample size planning of a phase III trial based on phase II data. Pharmaceutical Statistics 2006. 5:85-97 .
- Methodological issues with adaptation of clinical trial design. Pharmaceutical Statistics 2006. 5:99-107 .
- Methodological issues with adaptation of clinical trial design†. Pharmaceutical Statistics 2006. 5:- .
- A regulatory view on adaptive/flexible clinical trial design. Biometrical Journal 2006. 48:565-573 .
- Rejoinder†. Biometrical Journal 2006. 48:496-499 .
- A Regulatory View on Adaptive/Flexible Clinical Trial Design†. Biometrical Journal 2006. 48:- .
- A Tribute to Joachim Röhmel upon his retirement from the Federal Institute of Drugs. Biometrical Journal 2005. 47:- .
- A tribute to Joachim R\”ohmel upon his retirement from the federal institute of drugs. Biometrical Journal 2005. 47:10-11 .
- Independence of the statistician who analyses unblinded data. Statistics in Medicine 2004. 23:1527-1529 .
- Independence of the statistician who analyses unblinded data†. Statistics in Medicine 2004. 23:1527-1529 .
- Uncertainty in planning phase iII trial based on Phase II data: Sample size. .
- Sam Greenhouse: his contributions as a consultant to the Food and Drug Administration†. Statistics in Medicine 2003. 22:- .
- Utilities of the P-value Distribution Associated with Effect Size in Clinical Trials†. Biometrical Journal 2003. 45:659-669 .
- Utilities of the $P$-value distribution associated with effect size in clinical trials. Biometrical Journal 2003. 45:659-669 .
- Sam Greenhouse: His contributions as a consultant to the Food and Drug Administration. Statistics in Medicine 2003. 22:3285-3289 .
- Regulatory perspectives on data monitoring. Statistics in Medicine 2002. 21:2831-2842 .
- Regulatory perspectives on data monitoring†. Statistics in Medicine 2002. 21:- .
- Some fundamental issues with Non-inferiority testing in active controlled trials. .
- Commentary on ‘Alpha calculus in clinical trials: considerations and commentary for the new millennium’†‡. Statistics in Medicine 2000. 19:785-793 .
- Comment on ``Consensus and controversy in pharmaceutical statistics'' (Pkg: p135-176). Journal of the Royal Statistical Society, Series D: The Statistician 2000. 49:170-170 .
- Comment on ``Alpha calculus in clinical trials: Considerations and commentary for the new millennium'' (p767-779). Statistics in Medicine 2000. 19:785-793 .
- Comment on ``Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system''. The American Statistician 1999. 53:190-196 .
- Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies. Statistics in Medicine 1998. 17:- .
- Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: Linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies (Pkg: p1839-1862). Statistics in Medicine 1998. 17:1851-1858 .
- The behavior of the $P$-value when the alternative hypothesis is true. Biometrics 1997. 53:11-22 .
- Efficacy evaluation for monotherapies in two-by-two factorial trials. Biometrics 1995. 51:1483-1493 .
- Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: Issues of international harmonization. Statistics in Medicine 1995. 14:1117-1127 .
- The behavior of the $p$-value when the alternative hypothesis is true.. .
- Application of a vote-counting statistic in the analysis of treatment effect homogeneity in a multicenter clinical trial. .
- Conclusions. 2. Statistics in Medicine 1994. 13:1493-1499 .
- Training the next generation of biostatisticians. The American Statistician 1994. 48:280-284 .
- Conclusions. 2: Early stopping rules. Statistics in Medicine 1994. 13:1493-1499 .
- Efficacy evaluation for monotherapies in two-by-two factorial trials. .
- Some FDA perspectives on data monitoring in clinical trials in drug development (Disc: p609-614). Statistics in Medicine 1993. 12:601-608 .
- Some FDA perspectives on data monitoring in clinical trials in drug development. Statistics in Medicine 1993. 12:601-608 .
- Comment on ``Statistical issues arising in AIDS clinical trials''. Journal of the American Statistical Association 1992. 87:579-581 .
- Challenges of the future for statisticians in the biopharmaceutical field. .
- On sample sizes to estimate the protective efficacy of a vaccine. Statistics in Medicine 1988. 7:1279-1288 .
- Assessment of safety. .
- Statistical assessment of combination drugs: A regulatory view. .
- Sampling to a prespecified precision of the log odds ratio estimator: A sequential approach. .
- Sample sizes for estimation of the odds ratio in unmatched case-control studies. American Journal of Epidemiology 1984. 120:145-153 .
- Case-control studies: A sequential approach. American Journal of Epidemiology 1978. 108:415-424 .