Importance of protocols for simulation studies in clinical drug development

Statistical Methods in Medical Research

Volumn 20, Issue 6, 2011, Pages 613-622

  Smith, Mike K ^a   Marshall, Andrea ^b  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

Clinical trial simulations; design; drug development; pharmaceutical; protocol; Simulation study

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL SIMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RESEARCH; HUMAN; MATHEMATICAL MODEL; METHODOLOGY; PEER REVIEW; PERFORMANCE; SIMULATION; CLINICAL PRACTICE; CLINICAL STUDY; DATA ANALYSIS; DECISION MAKING; DRUG DEVELOPMENT; MATHEMATICAL COMPUTING; PROBABILITY; STUDY DESIGN;

CLINICAL TRIALS AS TOPIC; DRUG DESIGN;

EID: 84555189354     PISSN: 09622802     EISSN: 14770334     Source Type: Journal    
DOI: 10.1177/0962280210378949     Document Type: Article

References (46)

1. Thall PF. Bayesian clinical trial design in a cancer centre. Chance. 2001 ; 14: 23-28
2. Lipkovich I, Duan YY, Ahmed S. Multiple imputation compared with restricted pseudo-likelihood and generalized estimating equations for analysis of binary repeated measures in clinical studies. Pharmaceutical Statistics. 2005 ; 4 (4). 267-285 (Pubitemid 43013601)
3. Somerville M, Wilson T, Koch G, Westfall P. Evaluation of a weighted multiple comparison procedure. Pharmaceutical Statistics. 2005 ; 4 (1). 7-13 (Pubitemid 40425991)
4. Guidance for industry: population pharmacokinetics. Rockville, MD: US Food and Drug Administration ; 1999 :
5. Critical path initiative white paper: innovation or stagnation? challenge and opportunity on the critical path to new medical products. US Food and Drug Administration Rockville, MD ; 2004 :
6. Lee PID, Lesko LJ Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). Kimko HC Duffull SB, ed. New York: Marcel Dekker ; 2003: 201-210.
7. Bonate P, Gillespie WR, Ludden T, Rubin DB, Stanski D Draft publication of the Centre for Drug Development Science (CDDS). Holford NHG Hale M Ko HC Steimer J-L Sheiner LB Peck CC, ed. San Francisco: University of California ; 1999: 1-18.
8. Lalonde RL, Kowalski KG, Hutmacher MM, et al. Model-based drug development. Clinical Pharmacology and Therapeutics. 2007 ; 82 (1). 21-32 (Pubitemid 46950619)
9. Morita S, Sakamoto J. Application of an adaptive design to a randomized phase II selection trial in gastric cancer: a report of the study design. Pharmaceutical Statistics. 2006 ; 5 (2). 109-118 (Pubitemid 43891294)
10. Smith MK, Jones I, Morris MF, Grieve AP, Tan K. Implementation of a Bayesian adaptive design in a proof of concept study. Pharmaceutical Statistics. 2006 ; 5 (1). 39-50 (Pubitemid 43380267)
11. Holford NHG, Kimko HC, Monteleone JPR, Peck CC. Simulation of clinical trials. Annual Review of Pharmacology and Toxicology. 2000 ; 40: 209-234 (Pubitemid 30340680)
12. Burton A, Altman DG, Royston P, Holder RL. The design of simulation studies in medical statistics. Statistics in Medicine. 2006 ; 25 (24). 4279-4292 (Pubitemid 46023772)
13. Riggs MM, Godfrey CJ, Gastanguay MR Pharmacometrics-the science of quantitative clinical pharmacology. Ette EI Williams PJ, ed. Chichester: Wiley ; 2007: 881-900.
14. Burman CF, Hamren B, Olsson P. Modelling and simulation to improve decision-making in clinical development. Pharmaceutical Statistics. 2005 ; 4 (1). 47-58 (Pubitemid 40425995)
15. Williams PJ, Ette EI Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). Kimko HC Duffull SB, ed. New York: Marcel Dekker ; 2003: 74-103.
16. Kowalski KG, French JL, Smith MK, Hutmacher MM. A model-based framework for quantitative decision making in drug development. ; 2008 ; 2008.
17. Smith MK, French J, Kowalski K, Ewy W. Enhanced quantitative decision making-reducing the likelihood of incorrect decisions. ; 2009 ; 2009.
18. Kowalski KG, Olson S, Remmers AE, Hutmacher MM. Modeling and simulation to support dose selection and clinical development of SC-75416, a selective COX-2 inhibitor for the treatment of acute and chronic pain. Clinical Pharmacology and Therapeutics. 2008 ; 83 (6). 857-866 (Pubitemid 351704916)
19. Kimko HC, Duffull SB Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). Kimko HC Duffull SB, ed. New York: Marcel Dekker ; 2003: 1-16.
20. Bonate PL Pharmacometrics-the science of quantitative clinical pharmacology. Ette EI Williams PJ, ed. Chichester: Wiley ; 2007: 851-871.
21. Williams PJ, Lane JR Pharmacometrics-the science of quantitative clinical pharmacology. Ette EI Williams PJ, ed. Chichester: Wiley ; 2007: 873-880.
22. Kimko HC, Duffull SB Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). New York: Marcel Dekker ; 2003 :
23. Gelman A, Carlin JB, Stern HS, Rubin DB Bayesian data analysis. 20042. Florida, USA: Chapman & Hall/CRC. Florida, USA: Chapman & Hall/CRC ; 2004 :
24. Holford NGH Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). Kimko HC Duffull SB, ed. New York: Marcel Dekker ; 2003: 17-30.
25. Westfall PH, Tsai K, Ogenstad S, Tomoiaga A, Moseley S, Lu YG. Clinical trials simulation: a statistical approach. Journal of Biopharmaceutical Statistics. 2008 ; 18 (4). 611-630 (Pubitemid 351951535)
26. Little RJA, Rubin DB Statistical analysis with missing data. New York: John Wiley and Sons ; 1987 :
27. Girard P. Clinical trial simulation: a tool for understanding study failures and preventing them. Basic & Clinical Pharmacology & Toxicology. 2005 ; 96 (3). 228-234 (Pubitemid 40388000)
28. Hoffman D, Kringle R, Lockwood G, Turpault S, Yow E, Mathieu G. Nonlinear mixed effects modelling for estimation of steady state attainment. Pharmaceutical Statistics. 2005 ; 4 (1). 15-24 (Pubitemid 40425992)
29. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing ; 2004 :
30. Stroustrup B The C++ Programming Language (Special edn). Reading, MA: Addison-Wesley ; 2000 :
31. Smith MK, Pugh R, Francois R. MSToolkit-an R library for simulating and evaluating clinical trial designs and scenarios. ; 2009 ; 2009.
32. Chien JY, Friedrich S, Heathman MA, de Alwis DP, Sinha V. Pharmacokinetics/pharmacodynamics and the stages of drug development: role of modeling and simulation. The AAPS Journal. 2005 ; 7 (3). E544 - E559
33. O'Hagan A, Stevens JW, Campbell MJ. Assurance in clinical trial design. Pharmaceutical Statistics. 2005 ; 4 (3). 187-201 (Pubitemid 41358690)
34. Isukapalli SS, Roy A, Georgopoulos PG Pharmacometrics-the science of quantitative clinical pharmacology. Ette EI Williams PJ, ed. Chichester: Wiley ; 2007: 1069-1106.
35. Ette EI, Lockwood P, Miller R, Mandema J Applied statistics in the pharmaceutical industry. Millard SP Krause A, ed. New York: Springer ; 2001: 237-266.
36. Nestorov IA, Graham G, Duffull SB, Aarons L Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). Kimko HC Duffull SB, ed. New York: Marcel Dekker ; 2003: 313-325.
37. Mandema J, Wang W Simulation for designing clinical trials: a pharmacokinetic-pharmacodynamic modelling perspective (drugs & the pharmaceutical sciences). Kimko HC Duffull SB, ed. New York: Marcel Dekker ; 2003: 289-312.
38. Smith MK, Marshall S. A Bayesian design and analysis for dose-response using informative prior information. Journal of Biopharmaceutical Statisitics. 2006 ; 16 (5). 695-709 (Pubitemid 44844020)
39. Chan PLS, Nutt JG, Holford NHG. Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation. Pharmaceutical Research. 2007 ; 24 (4). 791-802 (Pubitemid 46411968)
40. Zhou YH, Lucini M. Gaining acceptability for the Bayesian decision-theoretic approach in dose-escalation studies. Pharmaceutical Statistics. 2005 ; 4 (3). 161-171 (Pubitemid 41358688)
41. Kong L, Koch G, Liu T, Wang H. Performance of some multiple testing procedures to compare three doses of a test drug and placebo. Pharmaceutical Statistics. 2005 ; 4 (1). 25-35 (Pubitemid 40425993)
42. Donner A, Hauck WW, Zou GY. The impact of missing values in the concentration-time curve on the assessment of bioequivalence. Pharmaceutical Statistics. 2005 ; 4 (2). 91-99 (Pubitemid 40895564)
43. Fedorov VV Theory of optimal experiments. New York: Academic Press ; 1972 :
44. Atkinson AC, Donev AN, Tobias R Optimum experimental designs, with SAS. Oxford: Oxford University Press ; 2007 :
45. Retout S, Duffull S, Mentre F. Development and implementation of the population Fisher information matrix for the evaluation of population pharmacokinetic designs. Computer Methods and Programs in Biomedicine. 2001 ; 65 (2). 141-151 (Pubitemid 32220157)
46. Parmigiani G Modeling in medical decision making: a Bayesian approach. Chichester: Wiley ; 2002 :