Practical and statistical considerations in designing an early phase II osteoarthritis clinical trial: A case study

Communications in Statistics - Theory and Methods

Volumn 38, Issue 18, 2009, Pages 3282-3296

  Ting, Naitee ^a  

^a PFIZER INC   (United States)

Author keywords

Dose response; Osteoarthritis; Phase II; Proof of concept

Indexed keywords

ANTI-INFLAMMATORY AGENTS; CLINICAL TRIAL; DOSE RESPONSE; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG SAFETY; MINIMUM EFFECTIVE DOSE; OSTEOARTHRITIS; PHASE II; PROOF OF CONCEPT; ROFECOXIB;

DRUG PRODUCTS;

RESEARCH;

EID: 70349638233     PISSN: 03610926     EISSN: 1532415X     Source Type: Journal    
DOI: 10.1080/03610920802382619     Document Type: Article

References (14)

1. Bellamy, N., Campbell, J., Stevens, J., Pilch, L., Stewart, C., Mahmood, Z. (1997). Validation study of a computerized version of the Western Ontario and Mcmaster Universities VA 3.0 Osteoarthritis Index. J. Rheumatol. 24:2413-2415.
2. Chang, M., Chow, S. C. (2006). Power and sample size for dose-response studies. Dose Finding in Drug Development. New York: Springer, pp. 220-241.
3. Dmitrienko, A., Weins, B., Westfall, P. (2006). Fallback tests in dose-response clinical trials. J. Biopharmaceut. Statist. 16(5):745-755.
4. Hamlett, A., Ting, N., Hanumara, C., Finman, J. (2002). Dose spacing in early dose response clinical trial designs. Drug Inform. J. 36(4):855-864.
5. Hochberg, Y. (1988). A sharper Bonferroni procedure for multiple tests of signi.cance. Biometrika 75:800-802.
6. ICH-E4 Harmonized Tripartite Guideline. (1996). Dose-Response Information to Support Drug Registration.
7. Pinheiro, J. C., Bretz, F., Branson, M. (2006). Analysis of dose-response studies - modeling approaches. Dose Finding in Drug Development. New York: Springer, pp. 146-171.
8. Potter, D. (2006). Phase I studies of chemotherapeutic agents in cancer patients: a review of the designs. J. Biopharmaceut. Statist. 16(5):579-604.
9. Robertson, T., Wright, F., Dykstra, R. (1988). Order Restricted Inference. New York: Wiley.
10. Ruberg, S. J. (1995). Dose response studies I. Some design considerations. J. Biopharmaceut. Statist. 5(1):1-14.
11. Smith, M. K., Marshall, S. (2006). A Bayesian design and analysis for dose-response using informative prior information. J. Biopharmaceut. Statist. 16(5):695-709.
12. Ting, N. (2003a). Dose Response Study Design, Encyclopedia of Biopharmaceutical Statistics. 2nd ed. London: Marcel Dekker, pp. 304-310.
13. Ting, N. (2003b). Drug Development, Encyclopedia of Biopharmaceutical Statistics. 2nd ed. London: Marcel Dekker, pp. 317-324.
14. Wong, W. K., Lachenbruch, P. A. (1996). Tutorial in biostatistics: designing studies for dose response. Statist. Med. 15:343-359.