000 03095nam a2200361| 4500
001 85969
005 20220308123207.0
010 _a978-4-431-55573-5
_dcompra
090 _a85969
100 _a20190128d2018 k||y0pory50 ba
101 0 _aeng
102 _aUS
200 1 _aModern dose-finding designs for cancer phase I trials
_bDocumento electrn̤ico
_edrug combinations and molecularly targeted agents
_fAkihiro Hirakawa, Hiroyuki Sato, Takashi Daimon, Shigeyuki Matsui
210 _aTokyo
_cSpringer Japan
_cSpringer
_d2018
215 _aXIII, 89 p.
_cil.
225 2 _aJSS Research Series in Statistics
300 _aColocaȯ̂: Online
303 _aThis book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of two agents. Development of dose-finding methods for two-agent combination trials requires reasonable models that can adequately capture joint toxicity probabilities for two agents, taking into consideration possible interactions of the two agents on toxicity probability such as synergistic or antagonistic effects. Another is clinical trials for evaluating both efficacy and toxicity outcomes in single- and two-agent combination trials. These methods are often applied to the phase I trials including MTAs because the toxicity and efficacy for a MTA does not monotonically increase with dose, but the efficacy often increases initially with the dose and then plateaus. Successful software implementations for several dose-finding methods are introduced in the book, and their operating characteristics in practice are discussed. Recent advance of the adaptive dose-finding methods in drug developments are also provided.
410 1 _x2364-0057
606 _93627
_aEstats̕tica
606 _91379
_aEstats̕tica matemt̀ica
606 _911537
_aMťodos estats̕ticos
680 _aQA276
700 _965670
_aHirakawa
_bAkihiro
702 _965671
_aAkihiro
_bHiroyuki
702 _965672
_aDaimon
_bTakashi
702 _964699
_aMatsui
_bShigeyuki
801 0 _gRPC
_aPT
856 _uhttps://doi.org/10.1007/978-4-431-55573-5
942 _2lcc
_cF
_n0