SennS. Statistical issues in drug development20082. Chichester, England: Wiley.
2.
JuliousSA. An introduction to statistics in early phase trial2010; Chichester, England: Wiley.
3.
BanerjeeATsiatisAA. Adaptive two-stage designs in phase II clinical trials. Stat Med2006; 25(19)3382–3395.
4.
StallardNToddS. Sequential designs for phase III clinical trials incorporating treatment selection. Stat Med2003; 22(5)689–703.
5.
WhiteheadJ. The Design and Analysis of Sequential Clinical Trials19972. Chichester: Wiley.
6.
WhiteheadJ. Group sequential trials revisited: Simple implementation using SAS. Stat Methods Med Res2011; 20(6): 635–656.
7.
StallardNToddS. Seamless phase II/III designs. Stat Methods Med Res; 20(6): 623–634.
8.
FernandesNStoneA. Multiplicity adjustments in trials with two correlated comparisons of interest. Stat Methods Med Res2011; 20(6): 579–594.
9.
BurtonAAltmanDGRoystonPHolderRL. The design of simulation studies in medical statistics. Stat Med2006; 25(24)4279–4292.
10.
SmithMKMarshallA. Importance of protocols for simulation studies in clinical drug development. Stat Methods Med Res2011; 20(6): 613–622.
11.
FDA Guidance for Industry, Non-Inferiority Clinical Trials (draft). March2010.
12.
Julious and Wang. Issues with indirect comparisons in clinical trials particularly with respect to non-inferiority trials. DIJ2008; 42(6)625–6331.
13.
JuliousOwen. A comparison of methods for sample size estimation for non-inferiority studies with binary outcomes. Stat Methods Med Res2011; 20(6): 595–612.
14.
JuliousS. Sample sizes for clinical trials. Chapman and Hall, London, England2009.
15.
SennSJuliousS. Measurement in clinical trials: a neglected issue for statisticians?Stat Med2009; 28: 3189–3209.
16.
SennSRolfeKJuliousSA. Investigating variability in patient response to treatment: a case study from a replicate cross-over study. Stat Methods Med Res2011; 20(6): 657–666.