Modelling in Drug Development

Simplicity, Complexity and Modelling

Volumn , Issue , 2011, Pages 35-49

  Senn, Stephen ^a  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

Drug development; Linear models; Non linear models; Phase III trials; Statistical modelling

Indexed keywords

DRUG DEVELOPMENT; NON-LINEAR MODEL; PHASE III TRIALS; STATISTICAL MODELLING;

EID: 84876322544     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781119951445.ch3     Document Type: Chapter

References (28)

1. Anisimov, V.V. and Fedorov, V.V. (2007) Modelling, prediction and adaptive adjustment of recruitment in multicentre trials. Statistics in Medicine, 26(27), 4958-4975.
2. Burman, C.F., Grieve, A. and Senn, S. (2007) Decision analysis in drug development. In A. Dmitrienko, C. Chuang-Stein and R. D'Agostino (eds), Pharmaceutical Statistics Using SAS: A Practical Guide. Cary, NC: SAS Institute.
3. Chen, J., Zhong, J. and Nie, L. (2008) Bayesian hierarchical modeling of drug stability data. Statistics in Medicine, 27(13), 2361-2380.
4. Cox, D.R. (1972) Regression models and life-tables (with Discussion). Journal of the Royal Statistical Society, Series B, 34(2), 187-220.
5. Cox, D.R. and McCullagh, P. (1982) Some aspects of analysis of covariance. Biometrics, 38(3), 541-561.
6. Fedorov, V. and Jones, B. (2005) The design of multicentre trials. Statistical Methods in Medical Research, 14(3), 205-248.
7. Ford, I., Norrie, J. and Ahmadi, S. (1995) Model inconsistency, illustrated by the Cox proportional hazards model. Statistics in Medicine, 14, 735-746.
8. Gail, M.H., Wieand, S. and Piantadosi, S. (1984) Biased estimates of treatment effect in randomized experiments with nonlinear regressions and omitted covariates. Biometrika, 71(3), 431-444.
9. Holford, N.H. and Sheiner, L.B. (1981) Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clinical Pharmacokinetics, 6(6), 429-453.
10. International Conference on Harmonisation (1999) Statistical principles for clinical trials (ICH E9). Statistics in Medicine, 18(15), 1905-1942.
11. Jesus de Almeida, J.L. et al. (2002) MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet, 360, 7-22.
12. Keene, O.N., Jones, M.R. Lane, P.W. a nd Anderson, J. (2007) Analysis of exacerbation rates in asthma and chronic obstructive pulmonary disease: example from the TRISTAN study. Pharmaceutical Statistics, 6(2), 89-97.
13. Keene, O.N., Calverley, P.M.A., Jones, P.W., Vestbo, J. and Anderson, J.A. (2008) Statistical analysis of exacerbation rates in COPD: TRISTAN and ISOLDE revisited. European Respiratory Journal, 32(1), 17-24.
14. Lee, Y. and Nelder, J.A. (2004) Conditional and marginal models: Another view. Statistical Science, 19, 219-228.
15. Lesaffre, E. and Senn, S. (2003) A note on non-parametric ANCOVA for covariate adjustment in randomized clinical trials. Statistics in Medicine, 22(23), 3583-3596.
16. Moore, K.L. and van der Laan, M.J. (2009) Covariate adjustment in randomized trials with binary outcomes: targeted maximum likelihood estimation. Statistics in Medicine, 28(1), 39-64.
17. O'Quigley, J., Pepe, M., and Fisher, L. (1990) Continual reassessment method: a practical design for phase1 clinical trials in cancer. Biometrics, 46, 33-48.
18. Racine, A., Grieve, A.P., Fluhler, H. and Smith, A.F.M. (1986) Bayesian methods in practice: experiences in the pharmaceutical industry. Applied Statistics, 35, 93-150.
19. Robinson, L.D. and Jewell, N.P. (1991) Some surprising results about covariate adjustment in logistic regression models. International Statistical Review , 59(2), 227-240.
20. Senn, S. (1989) Covariate imbalance and random allocation in clinical trials. Statistics in Medicine, 8, 1339-1350.
21. Senn, S. (1994) Testing for baseline balance in clinical trials. Statistics in Medicine, 13, 1715- 1726.
22. Senn, S. (2004a) Added values: Controversies concerning randomization and additivity in clinical trials. Statistics in Medicine, 23(24), 3729-3753.
23. Senn, S. (2004b) [Conditional and marginal models: another view]: Comment. Statistical Science, 19(2), 228-230.
24. Senn, S., Amin, D., Bailey, R.A., Bird, S.M., Bogacka, B., Colman, P., Garrett, A., Grieve, A. and Lachmann, P. (2007) Statistical issues in first-in-man studies. Journal of the R oyal Statistical Society, Series A, 170(3), 517-580.
25. Shaffer, J.P. (1991) The Gauss-Markov theorem and random regressors. American Statistician, 45(4), 269-273.
26. Suissa, S. (2006) Statistical treatment of exacerbations in therapeutic trials of chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine, 173(8), 842-846.
27. Tashkin, D.P., Celli, B., Senn, S., Burkhart, D., Kesten, S., Menjoge, S., Decramer, M. and UPLIFT Study Investigators (2008) A 4-year trial of tiotropium in chronic obstructive pulmonary disease. New England Journal of Medicine, 359(15), 1543-1554.
28. Tukey, J.W. (1993) Tightening the clinical trial. Controlled Clinical Trials, 14(4), 266-285.