Good practices for adaptive clinical trials in pharmaceutical product development

Drug Information Journal

Volumn 43, Issue 5, 2009, Pages 539-556

  Gaydos, Brenda ^a   Anderson, Keaven M ^b   Berry, Donald ^c   Burnham, Nancy ^d   Chuang Stein, Christy ^e   Dudinak, Jennifer ^f   Fardipour, Parvin ^g   Gallo, Paul ^h   Givens, Sam ^f   Lewis, Roger ⁱ   Maca, Jeff ^h   Pinheiro, José ^h   Pritchett, Yili ^j   Krams, Michael ^g  

^a ELI LILLY AND COMPANY   (United States)

^b Merck

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d Medtronic

^e Pfizer

^f ROCHE PRODUCTS LTD   (United Kingdom)

^g Wyeth ^*

^h NOVARTIS   (Switzerland)

ⁱ HARBOR UCLA MEDICAL CENTER   (United States)

^j ABBOTT LABORATORIES   (United States)

more..

Author keywords

Adaptive design; Best practices; Flexible design; Implementation; Planning

Indexed keywords

CLINICAL TRIAL; DATA ANALYSIS; DRUG DOSE REGIMEN; DRUG INDUSTRY; DRUG RESEARCH; FINANCIAL MANAGEMENT; GOOD CLINICAL PRACTICE; MONITORING; PRIORITY JOURNAL; PROCESS DESIGN; QUALITY CONTROL; REVIEW; SAMPLE SIZE; SIMULATION; STRATEGIC PLANNING;

EID: 70350139975     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150904300503     Document Type: Review

References (16)

1. Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J. Executive summary of the PhRMA Working Group on Adaptive Designs in Clinical Drug Development. J Biopharm Stat. 2006,16:275-283.
2. PhRMA Working Group on Adaptive Designs. Full white paper. Drug Inf J. 2006;40:421-484.
3. Quinlan JA, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Inf J. 2006;40:437-444. (Pubitemid 44721121)
4. Gaydos B, Krams M, Perevozskaya I, et al. Adaptive dose response studies. Drug Inf J. 2006;40:451-461.
5. Bornkamp B, Bretz F, Dmitrienko A, et al. Innovative approaches for designing and analyzing adaptive dose-ranging trials. J Biopharm Stat. 2007;17:965-995. Available at: http://biopharmnet.com/doc/doc12005.html. (Pubitemid 350135825)
6. Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M. Adaptive seamless phase II/III designs - background, operational aspects, and examples. Drug Inf J. 2006;4:463-473. (Pubitemid 44721124)
7. Gould AL, Shih WJ. Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance. Comm Stat. 1992;(A)21:2833-2853.
8. Sandvik L, Erikssen J, Mowinckel P, Rodland EA. A method for determining the size of internal pilot studies. Stat Med. 1996;15:1587-1590. (Pubitemid 26252620)
9. Chuang-Stein C, Anderson K, Gallo P, Collins S. Sample size reestimation: a review and recommendations. Drug Inf J. 2006;40:475-484. (Pubitemid 44721125)
10. Krams M, Lees KR, Hacke W, Grieve AP, Orgogozo J-M, Ford GA. Acute stroke therapy by inhibition of neutrophils (ASTIN): an adaptive dose response study of UK-279,276 in acute ischemic stroke. Stroke. 2003;34:2543-2548. (Pubitemid 37392736)
11. Berry DA, Müller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials. In Gatsonis C, Carlin B, Carriquiry A, eds., Case Studies in Bayesian Statistics V:99-181. New York: Springer-Verlag; 2001.
12. Berry DA. Bayesian clinical trials. Nature Rev Drug Discovery. 2006;5:27-36.
13. Gallo P, Chuang-Stein C. What should be the role of homogeneity testing in adaptive trials? Pharm Stat. 2009;8:1-4.
14. Posch M, Koenig F, Branson M, Brannath W, Dunger-Baldauf C, Bauer P. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Stat Med. 2005;24:3697-3714. (Pubitemid 43115726)
15. Brannath W, König F, Bauer P. Estimation in flexible two-stage designs. Stat Med. 2005;25:3366-3381.
16. Brannath W, Posch M, Bauer P. Recursive combination tests. J Am Stat Assoc. 2002;97:236-244.