Adaptive approaches in clinical drug development: Opportunities and challenges in design and implementation

Pharmaceutical Medicine

Volumn 23, Issue 3, 2009, Pages 139-148

  Krams, Michael ^a   Sharma, Amarnath ^a   Dragalin, Vlad ^a   Burns, Daniel D ^a   Fardipour, Parvin ^a   Padmanabhan, S Krishna ^a   Perevozskaya, Inna ^a   Littman, Gary ^b   Maguire, Robert ^a  

^a PFIZER INC   (United States)

^b Applied Clinical Intelligence   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; UNCLASSIFIED DRUG;

CLINICAL RESEARCH; CLINICAL TRIAL; DRUG DESIGN; DRUG DOSE ESCALATION; DRUG RESEARCH; HEALTH CARE PLANNING; HUMAN; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SIMULATION;

EID: 69249144477     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/bf03256762     Document Type: Review

References (19)

1. Gallo P, Chuang-SteinC, Dragalin V, et al. Executive Summary of the PhRMA Working Group on Adaptive Designs in Clinical Drug Development. J Biopharm Stat 2006; 16: 275-283
2. Committee forMedicinal Products for Human Use (CHMP). Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. CHMP/EWP/2459/02 [online]. Available from URL: http://www. emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf [Accessed 2009 Jun 4]
3. Dragalin V. Terminology and classification of adaptive designs. Drug Info J 2006; 40: 425-435
4. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990; 46: 33-48 (Pubitemid 20245604)
5. Haines LM, Perevozskaya I, Rosenberger WF. Bayesian optimal designs for phase I clinical trials. Biometrics 2003; 59: 561-600 (Pubitemid 37093398)
6. Dragalin V, Fedorov V. Adaptive designs for dose-finding based on efficacytoxicity response. J Stat Plan Inference 2006; 136 (6): 1800-1823 (Pubitemid 43193550)
7. Gaydos B, Krams M, Perevozskaya I, et al. Adaptive dose-response studies. Drug Info J 2006; 40: 451-461
8. Bornkamp B, Bretz F, Dmitrienko A, et al. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies: innovative approaches for designing and analyzing adaptive dose-ranging trials. J Biopharm Stat 2007; 17: 965-995
9. Grieve AP, KramsM. ASTIN: a Bayesian adaptive dose-response trial in acute stroke. Clin Trials 2005; 2: 340-351
10. Maca J, Bhattacharya S, Dragalin V, et al. Adaptive seamless phase II/III designs-background, operational aspects, and examples. Drug Info J 2006; 4: 463-473 (Pubitemid 44721124)
11. Jennison C, Turnbull BW. Group sequential methods with applications to clinical trials. New York: Chapman and Hall/CRC Press, 2000
12. Chuang-Stein C, AndersonK, Gallo P, et al. Sample size reestimation: a review and recommendations. Drug Info J 2006; 40: 475-484 (Pubitemid 44721125)
13. Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997; 61: 275-291 (Pubitemid 27145429)
14. Quinlan JA, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Info J 2006; 40: 437-444 (Pubitemid 44721121)
15. Dragalin V. Designing, monitoring, and modifying an adaptive trial. Am Pharm Outsourcing 2008; 9 (5): 12-16
16. Gaydos B, AndersonK, Berry DA, et al. Good adaptive practices. Drug Info J. In press
17. Enas G, Anderson K, Bedding A, et al. Global harmonization of standards for adaptive clinical trial designs. Regul Focus 2008; 13 (8): 8-17
18. Chuang-Stein C, Bretz F, Komiyama O, et al. Interactions with regulatory agencies to enhance the understanding and acceptance of adaptive designs. Regul Focus 2009; 14: 36-42
19. Lindley D. Prospects for the future: the next 50 years. J Royal Stat Soc Ser A 1984; 147: 359-367