Clinical Trial Methodology

Proschan MA, Shaw PA. Diagnosing Fraudulent Baseline Data in Clinical Trials. PLoS ONE 2020;15(9):e0239121. [PDF]

Shaw PA. Use of composite outcomes to assess risk-benefit in clinical trials. Clinical Trials, 2018;15(4):352-8. [PDF]

Xu R, Mehrotra D, Shaw PA. Hazard ratio inference in stratified clinical trials with time-to-event endpoints and limited sample size. Pharmaceutical Statistics, 2019 May; 8(3):366-376. [PDF]

Xu R, Mehrotra D, Shaw PA. Incorporating baseline measurement into the analysis of crossover trials with time-to-event endpoints. Statistics in Medicine, 2018 Oct; 37 (23): 3280-3292. [PDF]

Xu R, Shaw PA, Mehrotra DV: Hazard ratio estimation in small samples. Statistics in Biopharmaceutical Research 10(2): 139-149, 2018.

Oyama M, Shaw PA, and Ellenberg S.: Considerations for analysis of time-to-event outcomes subject to competing risks in veterinary clinical studies. Journal of Veterinary Cardiology, 20(3): 143-153, Jun 2018. [PDF]

Oyama MA, Ellenberg SS, Shaw PA. Clinical trials in veterinary medicine: A new era brings new challenges. Journal of Veterinary Internal Medicine 2017 Jul;31(4):970-978. [PDF]

Shaw PA, Fay MP: A rank test for bivariate event time outcomes when one event is a surrogate. Statistics in Medicine, 2016 Aug 30; 35(19):3413-23.

Anderson GL, Burns CJ, Larsen J, Shaw PA. Use of administrative data to increase the practicality of clinical trials: Insights from the Women’s Health Initiative. Clinical Trials, 2016 Oct; 13(5):519-26. [PDF]

Shepherd B, Shaw PA and Dodd L. Using audit Information to adjust parameter estimates for data errors in clinical trials. Clinical Trials, 2012 Dec; 9(6): 721-729. [PDF]