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[分享] Clinical Trial Methodology (2010)

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sampson2010 发表于 2015-5-29 12:42:00 | 显示全部楼层 |阅读模式

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Title: Clinical Trial Methodology. V  @& k. m5 k% v) t$ l7 m$ p
Author(s): Karl E. Peace, Din Chen8 e, h, w6 G/ P
Series: Biostatistics Series        * _4 E5 t% X8 u
Publisher: Chapman & Hall CRC9 _0 |! ~1 o0 E& a* G. j
Year: 2010       
5 V% {2 Z) n  J, i6 O" gEdition: 1  o8 Q# E0 @# ~
Language: English
  g$ F& x6 p6 YPages: 420( z* ~1 a  m" U
ISBN: 1584889179, 9781584889175, 1584889187, 9781584889182
5 ~' a2 @: d8 B8 ySize: 3 MB (2647392 bytes)
3 W9 Q# D: f4 n; W; Z5 ZExtension: pdf

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Features. |6 b: @. ]' M7 X5 `

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  • Reviews legislation pertinent to the clinical development of drugs
  • Discusses the processes of drug research and development within the context of a typical pharmaceutical company
  • Presents general biostatistical principles of clinical trials, including protocol development and statistical analysis plan development
  • Provides case studies of clinical trials for the development of drugs to treat panic attacks, duodenal ulcers, and Alzheimer’s disease; to reduce coronary heart disease risk; and to prevent gastric ulcers and angina2 j9 N  O4 {; l1 s3 ?  }7 b
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Summary
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Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors’ courses on the subject as well as the first author’s more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research.
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  H% v  O0 {7 s; r1 m! y1 u- ]From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors’ own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer’s disease.* B$ H! x( N/ J' V" f$ `. z
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Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence.0 g$ f/ S, R# V* I$ ?# ~) |
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Table of Contents
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& o6 u# _6 P% ^# P+ N. f1 [+ DOverview of Clinical Trial Methodology - w. P0 u5 \* P/ n& e' c3 ?' h
Clinical Trials
6 [# _. f$ a0 m( l  {Clinical Trial Methodology5 J% P! R! n. e9 H
Summary of Clinical Trial Methodology2 K" ~6 y5 S; Z( S  J
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Overview of the Drug Development Process and Regulation of Clinical Trials
$ t! |: q$ d5 W6 {, ]" CIntroduction5 C! Q& [4 r4 c$ A
The Drug Development Process% q8 b' \7 ], y: [- P, }: B  `% p
History of Drug Regulation3 B7 F3 c8 i/ w0 o6 M1 }' |. [
Principles of Adequate and Controlled Investigations& D/ m& l3 K% p/ K
Content and Format of the IND& D' x- Z& v2 `6 ~1 ]  D. b
Content and Format of the NDA- N/ M  ^' [; C, {0 u0 S7 b
Organizational Structure of the FDA1 K4 ^' E* L3 @2 E
The FDA Review Process 2 ]  t2 a/ k7 X% J1 a
Labeling and the Package Insert
- A/ O* N1 D6 @3 @6 yPharmaceutical Company Organization and Role of the Biostatistician
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8 V- a0 w0 N4 ?( ~  @0 K8 x1 BEthical Considerations in the Design and Conduct of Clinical Trials
# I. T; _/ y, S6 B. W' t  IIntroduction
3 [! N9 j! q5 AHistory and Evolution of Ethical Considerations in Clinical Trials: Key Milestones
5 y4 }2 I# u6 v8 P& i7 |Independent Review Boards
5 z' e+ B# b9 Z1 L$ X. _Clinical Trial Ethics: Who Should Practice?
6 C& s' C) n5 F0 X, o$ q4 qInformed Consent, Sample Size, and Power
# ?- n2 D# E) ~' T( DCommon Ethical Principles of Various Codes and Regulations: y" A+ ?! o; I/ x9 W
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Sample Size Considerations in Clinical Trials Pre-Market Approval . o8 k; |, w. o
Introduction. \( L( k! m) h
Phases of Clinical Trials and Objectives 9 c; w* e. B( H
The Clinical Development Plan: Pre-Market Approval3 |- T; c; G& K+ W
Sample Size Requirements
* W0 I3 r7 O8 T# h% V& NExamples
0 A7 i& s& a: q& uPhilosophical Issues  b1 [% ?2 V1 P

0 P8 b1 y, G9 ^  BSequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials . d6 u* j/ h4 w3 k
Introduction
) K% n* |2 h* F" ^" eSequential Procedures# K( J" P- [+ ?9 `- G9 z
Group Sequential Procedures
7 w8 S  A0 k: a: P0 k; N" a) ]. r! oStochastic Curtailment1 o8 Q+ _  c, v, e, o- E
Adaptively Designed Clinical Trials8 `- H# F' P/ C9 t2 C

" l- X% \  w6 J0 u8 eBiostatistical Aspects of the Protocol 3 }/ ^9 D5 ^% \3 R  n
The Background or Rationale # F) w; l4 T, m  r2 E& H. Y" h
Objective
1 ^: [; e  B& NPlan of Study
% Q# h( P- M: I  H) `+ iStatistical Analysis Section
5 A" {- p( T5 t  K' w0 Z( b! pAdministration
& }9 _5 c& L" j$ E# ]Protocol References Section
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The Statistical Analysis Plan + g! w9 F" _: b
Introduction2 k3 n* i' J' q  O( q4 y0 S% a0 ]% B
Protocol Objective
+ x1 w5 R: _3 a4 ^# Y" HEfficacy Data Collected and Protocol Schema   _8 x& F. d: d
Primary and Secondary Efficacy Endpoints
" M: V4 ?4 ~5 v* X" FObjectives, Translated as Statistical Hypotheses: |6 }" T+ J5 ]
Protocol Design Features
1 G/ E  k0 n2 S+ a" pStatistical Analyses$ d7 t* M  J! m" e

6 k6 g, f+ r# e$ R8 \- k* [; r, A2 w+ jPooling of Data from Multicenter Clinical Trials
) d4 @' Z; M, q. PIntroduction) h7 |* B* _, L# P' K5 L8 |2 X
Multicenter Clinical Trial Experimental Setting
( T8 i. e( ~) n- G9 s( wPre-Study Planning
& y' A8 E5 i8 y3 {) R( Z2 o6 xMulticenter Clinical Trial Conduct # M5 B; C' K8 `8 R' r% A
Biostatistical Analysis% d$ S* O" i1 `- Q& [) q* O

" j$ t0 u2 K+ T' v$ c4 M5 SValidity of Statistical Inference) K7 m0 K' q4 ?8 _: I8 J
Introduction
+ N# I, M" l9 X! ?* M/ ePlanning the Investigation" w/ m7 u" Z; O9 b: E
Conducting the Investigation
' E- M( y& \9 e  _1 KStatistical Analyses, Interpretation, and Inference ' \6 H6 U# q: [( o( T. F% ]
Reporting Results of Investigations0 ~5 J4 u* Z+ ?( s& B; Q, u
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Bioequivalence Clinical Trials 6 B- @/ d. B: X2 @4 p  n
Introduction
* r: [6 q* [0 j+ l. @: Z& D1 F' Y$ gAbsorption, Distribution, Metabolism, and Excretion (ADME) % }. y9 ~$ Q4 s: y( B; O
Bioavailability 4 v) T3 S* a  z" m
Factors That Affect Bioavailability
4 T* V: I  Y" l& eBlood Level Clinical Trials
. N1 A& X3 g5 t& W- U- s. _Bioequivalence
2 Y4 N6 O7 X+ ^/ D- L; B" v6 \Design of Bioequivalence Trials
+ u6 \# M6 V" U5 h: HAnalysis of Bioequivalence Trials % Z) _! C5 F* x0 k8 ~7 i3 [
Analysis of Ratios3 e# h& @( N% u1 b5 l
Pharmacokinetic Models : c1 r2 I' Q8 f% ?, G
Support of Bioequivalence Trials in the Pharmaceutical Industry
% v9 O4 w9 T  n2 Y' w# OExamples( @/ }9 a. ]$ ?* B8 o9 T+ G" S' D
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Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina * O/ i4 O0 R' s# t1 n" w" L% e
Introduction9 C# ?6 v% L; I7 m
Overview of Response Surface Methodology
3 [: \% e3 e8 x# _5 BFull Quadratic Response Surface Model
9 N: f8 D2 r+ {3 c. H3 }9 UPhase II Clinical Trial Program in Stress Test-Induced Angina: r" \* y" \% d4 y1 ]
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Confirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial
) Y1 V8 F8 M. o9 Y$ p& a- A5 v! DIntroduction
2 i1 U7 l7 ~4 X8 @1 nBackground
0 h1 d& S$ ?  }/ RObjective
7 l/ r5 W0 v9 z! d$ A& a" dDesigning and Planning the Investigation
. a- N6 v3 n' t% Q. CConducting the Investigation / G3 j" j8 g0 r6 ?7 q% [
Statistical Analyses
, c& i! A2 \( xOther Considerations0 y. f; U4 \; E
Innovative Aspects of the Clinical Trial Program/ k% p7 F! \& e8 ^) t# h

2 b( _  `, E+ P8 j  fPivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration 4 ]  N3 h8 ~4 ?& u1 E, `. r) i- O6 e8 K
Introduction. [% v& ?4 `! `) i8 l* g% b7 U
Rationale
* v' n9 Y8 m, n; ?" j0 ?, Y9 oThe Protocols
: _; R' a" _1 K- T) N. p) P. l2 SMonitoring and Data Management
# o4 A% E# R8 t$ q" d- f8 pFDA Meeting" o( T( m* H- D. Y9 A; |& u

- U& r  u- P/ O* T! p6 c  c; PClinical Trials in the Treatment of Alzheimer’s Disease Based upon Enrichment Designs
6 R  T8 x/ A! I5 G1 E$ U  q' o  EIntroduction
8 L' q0 F( R$ S/ M) C  MEnrichment Design Clinical Trials 5 u/ `. L; O  v) i& p! ~* _4 d
Objective
0 V; S, o# ^! F# Z& EPrimary Efficacy Endpoints * T# Y3 e7 {, ]5 {- g
Sample Size Determination0 ~+ y* h9 n) ^* R
Statistical Methods
# X- B: n  q* G3 Z( Z' E$ x1 H3 tResults/ r+ ~3 Y5 J$ ]4 v3 A5 n
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A Clinical Trial to Establish Reduction of CHD Risk ) ^. ^: n. [. Z
Introduction6 s. S3 h' h3 _. i' S8 O6 Y6 N
Objective
4 u7 W2 O1 {8 {8 C/ R$ aDesigning and Planning the Investigation 1 n3 ~! d$ W2 Y3 V% Q
Conducting the Investigation
; _+ Q: _4 _# S, Q/ zData Management
8 o7 ?1 |' d% a* E% m. x. ]Statistical Analyses
% f3 _! a1 L' {4 O5 f! s8 lResults
! W8 p7 u. Q2 z7 S: j  WSummary* p# }) v  A, `& D
+ M, M. c2 m/ P- I# O2 g. S) h5 Y
Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder
1 e& ~( O. |( m9 MIntroduction6 K# e3 t. W) d+ c5 o
Design of Pivotal Proof-of-Efficacy Trials
4 _$ K. k; ?6 e. u4 T" S  B8 A' QTraditional Statistical Analysis Methods 2 ]6 o9 @# v) w1 d; H; d% H
Overview of Efficacy Results of the Two Trials ' ]5 l+ ]1 G# j. D" v7 L( X
Alternative Design and Analysis Strategies
1 _4 X- i+ C  k  A0 @+ r2 ?' M0 ]7 Y' w, {! X
Combination Clinical Trials
4 k; \/ A5 b; i% N3 IIntroduction; Z! b5 t+ ]8 `0 s6 z' C5 P$ q) M+ N
Two-by-Two Factorial Design
3 s3 x0 }9 f5 H, w! cEffectiveness of the Combination6 ~* ~, F  W1 L9 H. ?2 Y
Contribution of Components to the Effectiveness of the Combination ! h$ e/ P9 u3 {  s
Factorial Designs in Other Clinical Development Areas1 |! Y: c1 j2 G5 j0 J
Example 1: Actifed in the Treatment of SAR Following DESI Review
( ^" }% R( w2 O0 f9 `Example 2: Crossover Trial of Actifed in the Treatment of SAR
/ c$ ~, Z, k: ^& ?, X3 E% gExample 3: Parallel Trial of Actifed in the Treatment of the Common Cold# m* G; a: O+ S% l0 N0 v
" a) [7 f- t% j5 l9 o& ]4 |7 Q
Monitoring Clinical Trials for Adverse Events
! [+ v) F+ {  }4 oIntroduction
+ R9 X! ]+ B% ^/ nDesigning for Safety: Antibiotic Rash Example
4 C) S- l  k) A6 qDesigning for Safety: Hypokalemia Example
. ^1 J) p: u- v: W- V# p3 e) VDesigning for Safety: Hypertensive Rebound Example ) R! z6 T$ @( E3 X  Q
Premarket Approval Trials: Designed for Efficacy
; w. ?+ y( g: LPremarket Approval Trials: Quality of Adverse Event Information
: u# A: z* a6 B& u. ~Monitoring for Safety
/ Q5 h- e" y2 v3 z& _7 LStatistical Methodology: Individual Trial6 Y( P1 \  q* x8 c7 u1 U9 P
Example
$ ~. i  O" k. e8 gStatistical Methodology: Across Trials2 L9 L6 G# d0 V" V  U) i
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Index" e" ~, N" I: L; O: l2 w

5 V5 t, f+ R; ^  b: R* uReferences appear at the end of each chapter.) @  |* R, }: m/ ^0 B
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$ Z9 b' k  O2 D$ Z* [/ tAuthor(s) Bio+ {  }5 B. O6 ]' e5 R9 e% E8 D

9 X( h# c7 G, y* @9 uKarl E. Peace is the Georgia Cancer Coalition Distinguished Cancer Scholar, founding director of the Center for Biostatistics, and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.
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Din Chen is the Karl E. Peace Endowed Eminent Scholar Chair in Biostatistics and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.
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tljuly 发表于 2017-12-23 23:08:15 | 显示全部楼层
好书!!多谢分享
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芬2012 发表于 2018-4-23 14:29:53 | 显示全部楼层
已下载,感谢分享
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1582891835 发表于 2018-7-26 10:51:39 | 显示全部楼层
多谢楼主分享~
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