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- Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine. Statistics in Medicine 2017. 36:92-104 .
- Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials. Statistics in Medicine 2016. 35:5561-5578 .
- Joint modeling of survival and longitudinal non-survival data: current methods and issues. Report of the DIA Bayesian joint modeling working group. Statistics in Medicine 2015. 34:2181-2195 .
- Responses to discussants of ‘Joint modeling of survival and longitudinal non-survival data: current methods and issues. report of the DIA Bayesian joint modeling working group’. Statistics in Medicine 2015. 34:2202-2203 .
- Bayesian adaptive determination of the sample size required to assure acceptably low adverse event risk. Statistics in Medicine 2014. 33:940-957 .
- Notes on the calculation of posterior probabilities related to outcomes from 2 X 2 matched pair tables. Model Assisted Statistics and Applications: An International Journal 2012. 7:245-250 .
- Detecting potential safety issues in clinical trials by Bayesian screening. Biometrical Journal 2008. 50:837-851 .
- Detecting potential safety issues in clinical trials by Bayesian screening. Biometrical Journal 2008. 50:837-851 .
- Accounting for Multiplicity in the Evaluation of “Signals” Obtained by Data Mining from Spontaneous Report Adverse Event Databases. Biometrical Journal 2007. 49:151-165 .
- A triage approach to evaluating safety incorporating frequentist and Bayesian methods. .
- Accounting for multiplicity in the evaluation of ''signals'' obtained by data mining by spontaneous report adverse event databases. Biometrical Journal 2007. 49:151-165 .
- How Practical are Adaptive Designs Likely to be for Confirmatory Trials?. Biometrical Journal 2006. 48:- .
- A triage approach to evaluating safety incorporating frequentist and Bayesian methods. .
- Timing of futility analyses for ‘proof of concept’ trials. Statistics in Medicine 2005. 24:1815-1835 .
- On the inappropriateness of an EM algorithm based procedure for blinded sample size re-estimation by T. Friede and M. Kieser, Statistics in Medicine 2002; 21:165--176. Statistics in Medicine 2005. 24:147-154 .
- Treatment comparisons for a partially categorical outcome applied to a biomarker with assay limit. Statistics in Medicine 2005. 24:211-228 .
- Comment on ``On the inappropriateness of an EM algorithm based procedure for blinded sample size re-estimation'' (2002V21 p165-176) (Pkg: p147-156). Statistics in Medicine 2005. 24:147-154 .
- Statistical decision theory approach to trial monitoring. .
- Industry, government, and academic panel discussion on multiple comparisons in a ``real'' phase three clinical trial. Journal of Biopharmaceutical Statistics 2003. 13:691-701 .
- A new approach for evaluating IVIVC that does not require common measurement times for dissolution and absorption. .
- Effect of within-household reinfestation on design sensitivity. Journal of Biopharmaceutical Statistics 2003. 13:327-336 .
- Using order statistics in clinical trial safety evaluation. .
- Substantial evidence of effect. Journal of Biopharmaceutical Statistics 2002. 12:53-77 .
- Comparison of alternative strategies for analysis of longitudinal trials with dropouts. Journal of Biopharmaceutical Statistics 2002. 12:207-226 .
- Biopharmaceutical statistics beyond 2000. Journal of Biopharmaceutical Statistics 2001. 11:1-8 .
- Sample size re-estimation: recent developments and practical considerations. Statistics in Medicine 2001. 20:2625-2643 .
- A practical approach for evaluating population and individual bioequivalence. Statistics in Medicine 2000. 19:2721-2740 .
- Mixed effects models. .
- Comment on ``Providing evidence of efficacy for a new drug''. Statistics in Medicine 1998. 17:1825-1827 .
- Multi-centre trial analysis revisited. Statistics in Medicine 1998. 17:- .
- Multi-centre trial analysis revisited (Pkg: p1753-1800). Statistics in Medicine 1998. 17:1779-1797 .
- Comment on papers on ``Assessment of the US FDA draft guidance on statistical procedures for bioequivalence studies'' (Pkg: p8-19). .
- Comment on ``Surrogate endpoints in AIDS drug development: Current status''. Drug Information Journal 1998. 32:453-456 .
- Modifying the design of ongoing trials without unblinding. Statistics in Medicine 1998. 17:89-100 .
- Issues in blinded sample size re-estimation. Communications in Statistics: Simulation and Computation 1997. 26:1229-1239 .
- Managing multiplicity in (bio)equivalence trials. .
- Comment on ``Individual bioequivalence -- A regulatory update''. Journal of Biopharmaceutical Statistics 1997. 7:23-29 .
- Re-evaluating design specifications of longitudinal clinical trials without unblinding when the key response is rate of change. Statistics in Medicine 1995. 14:2239-2248 .
- $P$-values for group sequential testing. Biometrika 1995. 82:650-654 .
- Planning and revising the sample size for a trial (Disc: p1053-1055). Statistics in Medicine 1995. 14:1039-1051 .
- PLANNING AND REVISING THE SAMPLE SIZE FOR A TRIAL. Statistics in Medicine 1995. 14:1039-1051 .
- Sample sizes for event rate equivalence trials using prior information. Statistics in Medicine 1993. 12:2009-2023 .
- Monitoring of clinical trials and interim analyses from a drug Sponsor's point of view. Statistics in Medicine 1993. 12:481-492 .
- Comment on ``Bayes/empirical Bayes modelling''. Statistics in Medicine 1992. 11:2017-2023 .
- Sample sizes for equivalence trials using prior information. .
- Discussion of papers of session 3: Bayes/empirical bayes. Statistics in Medicine 1992. 11:2017-2023 .
- Interim analyses for monitoring clinical trials that do not materially affect the type I error rate. Statistics in Medicine 1992. 11:55-66 .
- Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance. Communications in Statistics: Theory and Methods 1992. 21:2833-2853 .
- Another view of active-controlled trials. Controlled Clinical Trials 1991. 12:474-485 .
- Applying survival methodology to adverse experience occurrences in controlled clinical trials. Journal of Biopharmaceutical Statistics 1991. 1:57-66 .
- The analysis of titration studies in phase III clinical trials. Statistics in Medicine 1989. 8:583-591 .
- Applications of interval inference. .
- Scheduling interim analyses in group sequential trials. .
- Placebo comparisons in active-controlled trials. .
- Would the active treatment have differed from placebo?. .
- Sample sizes required for binomial trials when the true response rates are estimated. Journal of Statistical Planning and Inference 1983. 8:51-58 .
- Abandoning lost causes (early termination of unproductive clinical trials). .
- Group sequential methods for clinical trials allowing early acceptance of $H_0$ and incorporating costs. Biometrika 1982. 69:75-80 .
- A new approach to the analysis of clinical drug trials with withdrawals. Biometrics 1980. 36:721-727 .
- An APL file management system for processing large data files and directing output to remote printers. .
- Multivariate multiple comparisons using SAS. .
- A regression technique for angular variates. Biometrics 1969. 25:683-700 .
- Some relationships between the normal and von Mises distribution. Biometrika 1967. 54:684-687 .