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[分享] Design and Analysis of Clinical Trials for Predictive Medicine (2015)

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sampson2010 发表于 2015-5-29 12:57:14 | 只看该作者 回帖奖励 |倒序浏览 |阅读模式

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Title: Design and Analysis of Clinical Trials for Predictive Medicine
6 V9 ]' o' f。 h! E' NAuthor(s): Shigeyuki Matsui; Marc Buyse; Richard Simon7 f1 T1 b0 [* r, {
Series: Chapman & Hall/CRC biostatistics series9 h0 q$ Y7 K( x1 q8 D
Publisher: CRC Press% I, I& v7 A* }
City: Hoboken% v' o0 U- |/ h! m
Year: 2015       
/ M9 K  L: ~8 _& w1 cLanguage: English       
1 I  W& u0 |% j7 BPages: 394 p.7 W$ R; H- z2 c
ISBN: 9781466558168, 1466558164
4 V8 ~" S" Q1 D* KSize: 6 MB (6784770 bytes)        ' P$ F$ J$ \4 e6 @7 I2 {
Extension: pdf
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Features8 `. v2 f( P7 B2 }$ a9 v1 s2 x
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  • Provides statistical guidance for all stages of clinical trials for predictive medicine
  • Covers all of the main phases in clinical trials for developing molecular diagnostics and therapeutics
  • Presents the state of the art in biostatistics with suggestions for future research topics
  • Includes contributions from key researchers in clinical science and medicine% J& {- {5 U* V$ Q  K

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Summary
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Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics—from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.- _5 A- S% ?/ P( q, m9 n2 d

# ]# S& H" T; s# M# L, k4 `The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.% I( J& e# P7 j. U( Q
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This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.; o) F6 Q- d& u7 G6 p4 V% T% K
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Table of Contents
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5 E) T0 H" j/ l6 C6 r% wINTRODUCTORY OVERVIEW
3 `# B- i0 b0 B# cClinical Trials for Predictive Medicine: New Paradigms and Challenges% z! T! |% t+ G7 o, j5 S1 h
Richard Simon, Shigeyuki Matsui, and Marc Buyse% C+ X# ~  u+ ^( [3 W8 u6 |2 j
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An Industry Statistician’s Perspective on Personalized Health Care Drug Development
6 ?, ^2 P+ t& s! r1 F& E7 y% OJane Fridlyand, Ru-Fang Yeh, Howard Mackey, Thomas Bengtsson, Paul Delmar, Greg Spaniolo, and Grazyna Lieberman4 ^3 I2 A' J( ?2 }

" d1 j# u, f4 O/ b, s! b" a) lAnalytical Validation of In Vitro Diagnostic Tests
4 J% w. L) A8 KRobert Becker, Jr.
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2 j3 r- H7 {" A  }$ b/ sEARLY CLINICAL TRIALS USING BIOMARKERS
: \+ x5 Y8 }% {5 sPhase I Dose-Finding Designs and Their Applicability to Targeted Therapies% T' W& z9 N. j, @
Takashi Daimon, Akihiro Hirakawa, and Shigeyuki Matsui- [8 n! m7 M1 k3 G1 x8 r3 v0 }
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An Overview of Phase II Clinical Trial Designs with Biomarkers
) K# D# ~( |) yLisa McShane and Sally Hunsberger# A' r$ C8 E3 X3 ]
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Bayesian Adaptive Methods for Clinical Trials of Targeted Agents
9 q5 i8 c) }6 W% M' s7 EPeter Thall
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7 S3 |9 U+ Q' NOutcome-Adaptive Randomization in Early Clinical Trials% M7 ?) t# p& i& w
Edward Korn and Boris Freidlin2 ~) y) x4 o% X0 L. _1 a
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Challenges of Using Predictive Biomarkers in Clinical Trials5 C% p+ c2 @! \2 k
Sumithra Mandrekar and Daniel Sargent
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PHASE III RANDOMIZED CLINICAL TRIALS USING BIOMARKERS
3 L, X! X' P( f; ]" }4 zComparison of Randomized Clinical Trial Designs for Targeted Agents
5 @9 ~9 \% t) K0 o2 _Antje Hoering, Mike LeBlanc, and John Crowley) [& x0 Q8 Q  _2 F- b
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Phase III All-Comers Clinical Trials with a Predictive Biomarker+ N4 h( [" E7 K" n: i5 X: @8 ?
Shigeyuki Matsui, Yuki Choai, and Takahiro Nonaka
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% I7 V- I& ]& [" Q1 AEvaluation of Clinical Utility and Validation of Gene Signatures in Clinical Trials4 Z) {5 Y" F* W+ h
Stefan Michiels and Federico Rotolo
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6 N, K& H0 x) h8 o5 iANALYSIS OF HIGH-DIMENSIONAL DATA AND GENOMIC SIGNATURE DEVELOPMENTS  ?0 e+ L$ j( T
Statistical Issues in Clinical Development and Validation of Genomic Signatures
; j( t# ]6 O4 l8 y4 ~Shigeyuki Matsui
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: T4 A" Q- g' V2 i7 ~Univariate Analysis for Gene Screening: Beyond Multiple Testing0 e3 |; _6 o  J5 u
Hisashi Noma and Shigeyuki Matsui4 r4 A3 W/ Y! N7 J" l
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Statistical and Machine-Learning Methods for Class Prediction in High Dimension
5 I4 V- c* c& l, [* zOsamu Komori and Shinto Eguchi6 p" W/ u7 B" n. [+ D6 _$ E

* L" y1 V* K5 e/ `Survival Risk Prediction Using High-Dimensional Molecular Data
3 Q& T- i7 J2 q  ?/ @9 z3 ^0 hHarald Binder, Thomas Gerds, and Martin Schumacher4 M1 j' V0 t6 w
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RANDOMIZED TRIALS WITH BIOMARKER DEVELOPMENT AND VALIDATION" A3 l/ [1 a4 n
Adaptive Clinical Trial Designs with Biomarker Development and Validation" U$ N3 P: z( s7 F, l
Boris Freidlin and Richard Simon
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Development and Validation of Continuous Genomic Signatures in Randomized Clinical Trials
7 p5 O! j: H6 S) Q% c8 DShigeyuki Matsui) {. ]9 J# L: ]8 j9 x# a: \1 y7 U

/ i6 x& X# w! u& m6 LEVALUATION OF SURROGATE BIOMARKERS
: y; b5 {9 l$ V4 eBiomarker-Based Surrogate Endpoints: |  n; \  i. z5 R) F3 O
Marc Buyse, Tomasz Burzykowski, Geert Molenberghs, and Ariel Alonso, d! g! H  m& ^  q7 w* r

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Editor(s) Bio
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  r3 n$ ^: K  \- C  o. A/ YShigeyuki Matsui is a professor in the Department of Biostatistics at Nagoya University Graduate School of Medicine in Japan. He is also a visiting professor at the Institute of Statistical Mathematics. Dr. Matsui has served as council and nominating committee member of the International Biometric Society. He is currently council of the Biometric Society of Japan (BSJ) and editor-in-chief of the Japanese Journal of Biometrics. He is the recipient of the 2014 Award from the BSJ. Dr. Matsui is also a frequent reviewer commissioned by government and advisor to pharmaceutical companies in Japan. He holds degrees in engineering from the Tokyo University of Science in Japan.
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. U  V( |0 d  G  z  H6 G. G7 TMarc E. Buyse is the founder of the International Drug Development Institute in Louvain-la-Neuve, Belgium and of CluePoints Inc. in Cambridge, Massachusetts. He is also an associate professor of biostatistics at Hasselt University in Belgium. He was president of the International Society for Clinical Biostatistics, president of the Quetelet Society, and fellow of the Society for Clinical Trials. He worked at the European Organization for Research and Treatment of Cancer in Brussels and at the Dana Farber Cancer Institute in Boston. He holds degrees in engineering and statistics from Brussels University, management from the Cranfield School of Management in the UK, and a doctorate in biostatistics from Harvard University.! f8 ?0 M5 A9 w8 j8 N/ j9 ~

7 I4 Q2 `; ?# G' }) a, {Richard M. Simon is chief of the Biometric Research Branch at the National Cancer Institute in Bethesda, Maryland. He leads a multidisciplinary group of scientists developing and applying methods for the application of genomics to cancer therapeutics. Dr. Simon is the architect of BRB-ArrayTools software used for the analysis of microarray and digital expression, copy number, and methylation data. He is the recipient of the 2013 Karl E. Peace Award for Outstanding Statistical Contributions for the Betterment of Society and is the author or coauthor of more than 450 publications.+ ~! v) Q# ~, B; Z$ D
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Design and Analysis of Clinical Trials for Predictive Medicine (2015).pdf (6.47 MB, 下载次数: 64, 售价: 10 分钢镚) ) S0 o& R; {- T; y( G5 p  N% N

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