A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information

Statistics in Medicine

Volumn 29, Issue 9, 2010, Pages 959-971

  Stallard, Nigel ^a  

^a UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

Group sequential stopping boundary; Surrogate endpoint; Treatment selection

Indexed keywords

ARTICLE; CLINICAL STUDY; MEDICAL INFORMATION; METHODOLOGY; STATISTICAL ANALYSIS; STATISTICAL MODEL;

BIOSTATISTICS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, STATISTICAL; REGRESSION ANALYSIS; SAMPLE SIZE; TIME FACTORS;

EID: 77950912779     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3863     Document Type: Article

References (19)

1. Bretz F, Schmidli H, König F, Racine A, Maurer W. Confirmatory seamless phase II/ III clinical trials with hypotheses selection at interim: general concepts. Biometrical Journal 2006; 48:623-634. (Pubitemid 44367905)
2. Schmidli H, Bretz F, Racine A, Maurer W. Confirmatory seamless phase II/ III clinical trials with hypotheses selection at interim: general concepts. Biometrical Journal 2006; 48:635-649. (Pubitemid 44367905)
3. Thall PF, Simon R, Ellenberg SS. Two-stage selection and testing designs for comparative clinical trials. Biometrika 1988; 75:303-310.
4. Thall PF, Simon R, Ellenberg SS. A two-stage design for choosing among several experimental treatments and a control in clinical trials. Biometrics 1989; 45:537-547. (Pubitemid 19165264)
5. Stallard N, Todd S. Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine 2003; 22:689-703. (Pubitemid 36266961)
6. Engel B, Walstra P. Increasing precision or reducing expense in regression experiments by using information from a concomitant variable. Biometrics 1991; 47:13-20.
7. Galbraith S, Marschner IC. Interim analysis of continuous long-term endpoints in clinical trials with longitudinal outcomes. Statistics in Medicine 2003; 22:1787-1805. (Pubitemid 36603554)
8. Jennison C, Turnbull BW. Group-sequential analysis incorporating covariate information. Journal of the American Statistical Association 1997; 92:1330-1341. (Pubitemid 127387238)
9. Slud EV, Wei LJ. Two-sample repeated significance tests based on the modified Wilcoxon statistics. Journal of the American Statistical Association 1982; 77:862-868.
10. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70:659-663.
11. Jennison C, Turnbull BW. Confirmatory seamless phase II/ III clinical trials with hypotheses selection at interim: opportunities and limitations. Biometrical Journal 2006; 48:650-655. (Pubitemid 44367908)
12. Stallard N, Friede T. Flexible designs for treatment selection. Statistics in Medicine 2008; 27:6209-6227.
13. Whitehead J. The Design and Analysis of Sequential Clinical Trials. Wiley: Chichester, 1997.
14. Whitehead J. Overruning and underrunning in sequential clinical trials. Controlled Clinical Trials 1992; 13:106-121.
15. Wilkinson D, Murray J. Galantamine: a randomized, double-blind, dose comparison in patients with Alzheimer's disease. International Journal of Geriatric Psychiatry 2001; 16:852-857. (Pubitemid 32926767)
16. Bauer P, Posch M. Letter to the editor. Statistics in Medicine 2004; 23:1333-1334.
17. Todd S, Stallard N. A new clinical trial design combining phases II and III: sequential designs with treatment selection and a change of endpoint. Drug Information Journal 2005; 39:109-118. (Pubitemid 40647117)
18. Julious SA, Mullee MA. Issues with using baseline in last observation carried forward analysis. Pharmaceutical Statistics 2008; 7:142-146.
19. Friede T, Stallard N. A comparison of methods for adaptive treatment selection. Biometrical Journal 2008; 50:767-781.