Innovative approaches for designing and analyzing adaptive dose-ranging trials

Journal of Biopharmaceutical Statistics

Volumn 17, Issue 6, 2007, Pages 965-995

  Bornkamp, Björn ^a   Bretz, Frank ^b   Dmitrienko, Alex ^c   Enas, Greg ^c   Gaydos, Brenda ^c   Hsu, Chyi Hung ^d   König, Franz ^e   Krams, Michael ^d   Liu, Qing ^f   Neuenschwander, Beat ^b   Parke, Tom ^g   Pinheiro, José ^b   Roy, Amit ^h   Sax, Rick ⁱ   Shen, Frank ^h  

^a TU DORTMUND UNIVERSITY   (Germany)

^b NOVARTIS PHARMA AG   (Switzerland)

^c ELI LILLY AND COMPANY   (United States)

^d PFIZER INC   (United States)

^e MEDICAL UNIVERSITY OF VIENNA   (Austria)

^f JOHNSON AND JOHNSON   (United States)

^g Johnson and Johnson PRD ^*  (United Kingdom)

^h BRISTOL MYERS SQUIBB   (United States)

ⁱ ASTRAZENECA   (United Kingdom)

Author keywords

Dose finding; Dose response; Flexible designs; Modeling; Phase II trials; Proof of concept; Target dose

Indexed keywords

ANALYSIS OF VARIANCE; CONFERENCE PAPER; DOSE CALCULATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG RESEARCH; PRIORITY JOURNAL; WESTERN HEMISPHERE;

CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INDUSTRY; HUMANS; RESEARCH DESIGN; SAMPLE SIZE;

EID: 36248961734     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400701643848     Document Type: Conference Paper

References (13)

1. Berry, D. A., Mueller, P., Grieve, A. P., Smith, M. K., Parke, T., Krams, M. (2002). Bayesian designs for dose-ranging drug trials. In: Gatsonis, C., Kass, R. E., Carlin, B., Carriquiry, A., Gelman, A., Verdinelli, I., West, M., eds. Case Studies in Bayesian Statistics. Vol. 5. New York: Springer-Verlag, pp. 99-181.
2. Bretz, F., Pinheiro, J., Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics 61:738-748.
3. Bretz, F., Schmidli, H., Koenig, F., Racine, A., Maurer, W. (2006). Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts. Biometrical Journal 48(4):623-634.
4. Capizzi, T., Survill, T. T., Heyse, J. F., Malani, H. (1992). An empirical and simulated comparison of some tests for detecting progressive of response with increasing doses of a compound. Biometrical Journal 34:275-289.
5. Dunnett, C. W. (1955). A multiple comparison procedure for comparing several treatments with a control. J. Amer. Statist. Assoc. 50:1096-1121.
6. Gallo, P. (2006). Confidentiality and trial integrity issues for adaptive designs. Drug Information Journal 40(6):445-450.
7. Krams, M., Lees, K. R., Hacke, W., Grieve, A. P., Orgogozo, J. M., Ford, G. A. for the ASTIN Study investigators. (2003). ASTIN: An adaptive dose-response study of UK-279,276 in acute ischemic stroke. Stroke 34:2543-2548.
8. Loader, C. (1999). Local Regression and Likelihood. New York: Springer.
9. Maca, J., Bhattacharya, S., Dragalin, V., Gallo, P., Krams, M. (2006). Adaptive seamless phase II/III designs - background, operational aspects, and examples. Drug Information Journal 40(4):463-473.
10. Quinlan, J. A., Krams, M. (2006). Implementing adaptive designs: Logistical and operational considerations. Drug Information Journal 40(6):437-444.
11. Stewart, W. H., Ruberg, S. J. (2000). Detecting dose response with contrasts. Statistics in Medicine 19:913-921.
12. Tukey, J. W., Ciminera, J. L., Heyse, J. F. (1985). Testing the statistical certainty of a response to increasing dose of a drug. Biometrics 41:295-301.
13. West, M., Harrison, P. J. (1997). Bayesian Forecasting and Dynamic Models. New York: Springer-Verlag.