Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies

被引：24

作者：

Pinheiro, Jose ^{[1
]}

Sax, Frederic ^{[2
]}

Antonijevic, Zoran ^{[3
]}

Bornkamp, Bjorn ^{[4
]}

Bretz, Frank ^{[5
]}

Chuang-Stein, Christy ^{[6
]}

Dragalin, Vladimir ^{[7
]}

Fardipour, Parvin ^{[7
]}

Gallo, Paul ^{[1
]}

Gillespie, William ^{[8
]}

Hsu, Chyi-Hung ^{[1
]}

Miller, Frank ^{[9
]}

Padmanabhan, S. Krishna ^{[7
]}

Patel, Nitin ^{[10
]}

Perevozskaya, Inna ^{[7
]}

Roy, Amit ^{[11
]}

Sanil, Ashish ^{[12
]}

Smith, Jonathan R. ^{[13
]}

机构：

[1] Novartis Pharmaceut, E Hanover, NJ USA

[2] AstraZeneca, Wilmington, DE USA

[3] Quintiles Inc, Morrisville, NC USA

[4] TU Dortmund Univ, Dortmund, Germany

[5] Novartis AG, Basel, Switzerland

[6] Pfizer, Kalamazoo, MI USA

[7] Wyeth Res, Collegeville, PA USA

[8] Metrum Inst, Augusta, ME USA

[9] AstraZeneca, Sodertalje, Sweden

[10] Cytel, Cambridge, MA USA

[11] Bristol Myers Squibb Co, Princeton, NJ USA

[12] Berry Consultants, College Stn, TX USA

[13] Adapt Plus LLC, Durham, NC USA

来源：

STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2010年 / 2卷 / 04期

关键词：

Dose-finding; Dose-response; Exposure-response; Minimum effective dose; Net present value; PK/PD; Response-adaptive; Target dose; OPTIMAL DESIGNS;

D O I：

10.1198/sbr.2010.09054

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Poor dose-regimen selection remains a key cause of the high attrition rate of investigational drugs in confirmatory trials, being directly related to the escalating costs of drug development. This article is a follow-up to the first white paper put forward by the PhRMA Working Group (WG) on Adaptive Dose-Ranging Studies (Bornkamp et al. 2007). It presents results and conclusions from a new round of simulation-based evaluations conducted by the WG, proposing a new set of recommendations to improve the accuracy and efficiency of dose-finding in clinical drug development.

引用

页码：435 / 454

页数：20

共 10 条

[1]

[Anonymous], 2004, CHALL OPP CRIT PATH

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