ASTIN: a Bayesian adaptive dose-response trial in acute stroke

被引：52

作者：

Grieve, AP ^{[1
]}

Krams, M

机构：

[1] Pfizer Global Res & Dev, Stat Res & Consulting Ctr, Sandwich CT13 9NJ, Kent, England

[2] Pfizer Inc, Clin CNS, Groton, CT 06340 USA

来源：

CLINICAL TRIALS | 2005年 / 2卷 / 04期

关键词：

D O I：

10.1191/1740774505cn094oa

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Understanding the dose-response is critical for successful drug development. We describe an adaptive design to efficiently learn about the dose-response and the ED(95). A dynamic termination rule allows for early discontinuation either for efficacy or futility. The design was deployed in ASTIN, a phase II proof-of-concept trial of the neuroprotectant, neutrophil inhibitory factor (NIF), in acute stroke. We discuss the learning from this trial.

引用

页码：340 / 351

页数：12

共 9 条

[1]

Berry D.A., 2002, Case Studies in Bayesian Statistics, V5, P99

[2] OUTCOME AND TIME-COURSE OF RECOVERY IN STROKE .1. OUTCOME - THE COPENHAGEN STROKE STUDY [J].

JORGENSEN, HS ;

NAKAYAMA, H ;

RAASCHOU, HO ;

VIVELARSEN, J ;

STOIER, M ;

OLSEN, TS .

ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION, 1995, 76 (05) :399-405

[3] Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN) - An adaptive dose-response study of UK-279,276 in acute ischemic stroke [J].

Krams, M ;

Lees, KR ;

Hacke, W ;

Grieve, AP ;

Orgogozo, JM ;

Ford, GA .

STROKE, 2003, 34 (11) :2543-2548

[4] UK-279,276, a neutrophil inhibitory glycoprotein, in acute stroke - Tolerability and pharmacokinetics [J].

Lees, KR ;

Diener, HC ;

Asplund, K ;

Krams, M .

STROKE, 2003, 34 (07) :1704-1709

[5] Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans [J].

Lesko, LJ ;

Rowland, M ;

Peck, CC ;

Blaschke, TF .

JOURNAL OF CLINICAL PHARMACOLOGY, 2000, 40 (08) :803-814

[6] CHOICE OF NUMBER OF DOSES FOR MAXIMUM-LIKELIHOOD-ESTIMATION OF THE ED50 FOR QUANTAL DOSE-RESPONSE DATA [J].

MULLER, HG ;

SCHMITT, T .

BIOMETRICS, 1990, 46 (01) :117-129

[7] Learning versus confirming in clinical drug development [J].

Sheiner, LB .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 1997, 61 (03) :275-291

[8]

TAMURA RN, J AM STAT ASS, V89, P768

[9]

West M., 2006, Bayesian forecasting and dynamic models

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