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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; `( }- C2 d: o/ t; l  L
Author(s): Karl E. Peace, Din Chen
- m; m" x/ i: L1 w1 ?/ HSeries: Biostatistics Series        9 R3 m4 u  u5 V0 y# C* y
Publisher: Chapman & Hall CRC! u$ R& r8 ~9 R0 a/ F  g
Year: 2010        2 b( u/ f! r+ b0 Z" ~) D
Edition: 1# `1 {8 B5 B) O# }, B# Q
Language: English
( ~9 `9 E1 s0 t& W% APages: 4208 w0 {+ h0 R" Q  k+ ?+ p
ISBN: 1584889179, 9781584889175, 1584889187, 9781584889182
  T1 N, M$ |' v! b# cSize: 3 MB (2647392 bytes)
1 e/ Z1 d& u7 J& y/ yExtension: pdf

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6 ?( Y  M+ O6 ZFeatures
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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 angina
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Summary
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9 n5 S; R# T, E& @0 XNow 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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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.
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+ c/ \5 T  C8 `6 B. S0 hAided 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.
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Table of Contents
$ R4 f, y; B! S2 W0 a. a3 s; q7 C  q! o
Overview of Clinical Trial Methodology
. U) R9 k! }& E$ TClinical Trials & Z. T! F1 `5 F% Y/ C4 v
Clinical Trial Methodology
4 t  P8 r& \$ V; A0 d8 [% w3 RSummary of Clinical Trial Methodology$ F/ `8 C# O) D
( o& q2 X+ h4 X; j# Z- |
Overview of the Drug Development Process and Regulation of Clinical Trials
1 b% @  N) j- `6 Y; j# P, TIntroduction
8 M. b- |- _: j1 W+ O* lThe Drug Development Process
0 `4 F  a6 `+ `% {. m; r2 R# e) _" V' pHistory of Drug Regulation4 V/ t0 ?6 H$ C; i, Y$ |6 Z
Principles of Adequate and Controlled Investigations
& R' \2 ?! E7 SContent and Format of the IND- v) h2 K7 T' l" b4 T0 D
Content and Format of the NDA
- K+ i) f- x8 T* y1 j+ R( E  r# BOrganizational Structure of the FDA  @7 k0 X% v% b- b6 H
The FDA Review Process
. I  D4 C9 D+ n' j% vLabeling and the Package Insert & F/ b" E8 i( ~1 Z- |3 [9 q
Pharmaceutical Company Organization and Role of the Biostatistician
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& c/ `; H0 o7 \$ E8 y# w0 J) uEthical Considerations in the Design and Conduct of Clinical Trials
0 Q4 p% J4 z% Y- AIntroduction
$ y5 t0 M: x/ p8 I5 l( tHistory and Evolution of Ethical Considerations in Clinical Trials: Key Milestones
  d9 D- d. f: GIndependent Review Boards7 z: w% \: D$ I; W* k" L, l
Clinical Trial Ethics: Who Should Practice?
. ]- ?( D% w% Y2 g7 gInformed Consent, Sample Size, and Power# M$ i+ k6 K7 u. a
Common Ethical Principles of Various Codes and Regulations
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/ w& n3 |1 u, V- g  ?( FSample Size Considerations in Clinical Trials Pre-Market Approval
) ]' m0 U- \! i5 lIntroduction
& `9 N/ b( K# r* }Phases of Clinical Trials and Objectives
2 M: Q) k# e9 A, s# XThe Clinical Development Plan: Pre-Market Approval( ^7 A7 S( t3 {: t# z" j
Sample Size Requirements
4 q" h0 K3 w1 K# N1 F6 [3 `Examples# b1 b+ x7 B! K6 n" @' w+ s
Philosophical Issues
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; r& V/ ]' l9 D! ~Sequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials # k$ s# Q. U6 ?0 y  O/ }5 N
Introduction
3 o! i- P% F$ R1 ~7 @- n6 A2 r5 f1 qSequential Procedures3 S8 x' ?& N/ B+ A
Group Sequential Procedures/ C, d# S& E( y; J. F$ b! S0 V( g
Stochastic Curtailment
) G( H$ ~0 K6 rAdaptively Designed Clinical Trials
6 Z& V1 _5 y+ [  X6 ]6 ]: t+ ^  A! c8 M" ~+ P* ~5 K9 h% z
Biostatistical Aspects of the Protocol ; d2 a6 ^, K; C0 d4 k% r. n/ I0 @
The Background or Rationale
: Y+ M9 T- z! N& c7 JObjective
. `% k, x7 n* _( I' UPlan of Study
1 m# I* \& Q/ b1 F% k1 {7 x) L1 }Statistical Analysis Section
$ g! ]2 y& E; Y* ^, MAdministration8 F- B* t9 q- c* C9 n
Protocol References Section
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The Statistical Analysis Plan ; q5 s- [6 N: C! h4 B! C
Introduction
3 g* D8 z5 C  y% T/ I. wProtocol Objective
( t) n5 y# L  H6 y; |! s' f7 kEfficacy Data Collected and Protocol Schema 2 j0 y) |( F6 q9 b
Primary and Secondary Efficacy Endpoints9 Y  G# T9 Z: q* l! a
Objectives, Translated as Statistical Hypotheses7 y) h% @/ r0 J! \2 P/ U" ?
Protocol Design Features
+ }) o6 c! s( F% r, P2 M7 `Statistical Analyses
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Pooling of Data from Multicenter Clinical Trials- o( {- I* o5 [* K
Introduction9 Q% `. w$ J# Z: T+ R/ W
Multicenter Clinical Trial Experimental Setting
9 n* j& E4 p( O7 V' ?Pre-Study Planning
* M2 T( t; @3 Q5 G6 O& E0 {1 gMulticenter Clinical Trial Conduct $ ~7 M6 [" |0 V4 q. c1 _' O) l
Biostatistical Analysis
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Validity of Statistical Inference
6 T& p# V" s& f2 f+ H1 j2 N# rIntroduction
- d2 t  i2 c7 H( zPlanning the Investigation
/ d, L* i$ H' S  tConducting the Investigation
, [& w2 I8 s5 KStatistical Analyses, Interpretation, and Inference ) Z+ n3 t/ [! r" h
Reporting Results of Investigations( T% l, w" p- B- Y  `, e: l0 v
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Bioequivalence Clinical Trials , x: W& S' s# i% m. N* s# D
Introduction
* E& t  x* s$ v2 TAbsorption, Distribution, Metabolism, and Excretion (ADME)
: X" x# @+ T( d  FBioavailability * O- F$ L' I1 [  `2 x7 g7 N# j
Factors That Affect Bioavailability$ j6 h* D- J5 b+ N3 X  E
Blood Level Clinical Trials
! e! m4 H  {' c, ]Bioequivalence
$ O% |" f, W1 k+ u4 ]Design of Bioequivalence Trials: \) G) z6 W( u( N. Z+ i/ Y* w
Analysis of Bioequivalence Trials
6 v; W* Z& A: \# mAnalysis of Ratios) ?0 Q+ ^1 E+ G$ D
Pharmacokinetic Models 7 B5 H6 w3 k4 X# Q; l
Support of Bioequivalence Trials in the Pharmaceutical Industry
* [/ `2 }. n  w' v8 P, yExamples4 o: `: q9 n  U; ~$ K
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Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina # n  ]1 f( K$ E% P" ]3 ?! j3 V
Introduction) `3 C+ l( {, G# o. [4 @. @5 j
Overview of Response Surface Methodology" [; l# _; t' s& S4 P  \) m2 O5 v7 m* ^
Full Quadratic Response Surface Model; Q$ ~7 D3 s+ G
Phase II Clinical Trial Program in Stress Test-Induced Angina
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/ d$ \: Z2 f; T5 U, y' mConfirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial , o) N' h5 \9 f$ c2 ?8 x
Introduction% ~" b- A- r) C! N( p
Background
& V: t8 u$ s9 U6 `( c5 z7 w) j+ aObjective
6 u0 V# X. M) ^Designing and Planning the Investigation
: @5 A+ e" }5 \" vConducting the Investigation / l: j! S. \: O( i% H
Statistical Analyses
9 h' P9 i! j) c8 b. {Other Considerations
. |; f: M6 L/ }& o7 e, eInnovative Aspects of the Clinical Trial Program
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Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration ; \+ H  b2 B3 D! F2 ]5 N$ i
Introduction, q- u5 D% g  z  c4 B0 `( {0 g
Rationale 7 a! K$ f8 S! c8 j7 n* E
The Protocols
% a, e* ]3 y0 iMonitoring and Data Management
3 a) N+ `& ^- A' ^+ V5 K( F6 O+ SFDA Meeting
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Clinical Trials in the Treatment of Alzheimer’s Disease Based upon Enrichment Designs
( E; P% p1 E1 kIntroduction5 o) G, n2 T7 [. S9 [  x
Enrichment Design Clinical Trials
8 k+ }/ x2 C3 x: e& ?Objective
- A7 t- z) T9 l: R, _. ]4 E5 zPrimary Efficacy Endpoints / x1 H* _+ f4 L% ^
Sample Size Determination- T% Q  y' z# j3 h7 C" N
Statistical Methods
$ l. A; L4 Y+ U+ q' e7 R( iResults
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A Clinical Trial to Establish Reduction of CHD Risk * s6 y' I1 o+ d9 D
Introduction
# ]  ?1 F2 T# V6 o' O6 m2 FObjective
% {' _$ u& f- c7 }6 n: Q( vDesigning and Planning the Investigation
/ O2 {, K, o8 O% Q1 |Conducting the Investigation
# Z' O' w2 n; O# L0 qData Management
8 y# B4 q# s+ Q1 s& LStatistical Analyses
+ @- u) B! |8 r8 X$ BResults
+ P2 E6 V6 k  K) w5 H7 BSummary
$ b0 t1 k+ k+ O3 b4 g# Y: |$ g' X- A5 X6 E' L( V* J/ O2 x% I
Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder ! {# C7 o" G3 o: v
Introduction
& P# |! H  i) v  m1 f. RDesign of Pivotal Proof-of-Efficacy Trials
; @" k: h8 V7 k- q/ x. G9 m- n0 [Traditional Statistical Analysis Methods ' c9 H2 S+ |8 W- ~' t
Overview of Efficacy Results of the Two Trials . Y: x' l9 X" E$ r5 K6 [
Alternative Design and Analysis Strategies
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7 t2 j: `# \9 I: r5 OCombination Clinical Trials
+ W2 p* I/ V& j7 f, _6 SIntroduction! I- M1 t! D* O( I( D. T1 }8 I
Two-by-Two Factorial Design * p7 u2 c" V& L; ^, k# F3 }& ^6 N
Effectiveness of the Combination% d. m( V9 f! l5 z
Contribution of Components to the Effectiveness of the Combination
4 c% J8 r. m+ R* m  gFactorial Designs in Other Clinical Development Areas
" u9 v/ W1 @4 T  {, MExample 1: Actifed in the Treatment of SAR Following DESI Review
# W- i) O# {9 J; i7 z; ZExample 2: Crossover Trial of Actifed in the Treatment of SAR
! O8 R$ L4 m+ w* e- S7 c1 RExample 3: Parallel Trial of Actifed in the Treatment of the Common Cold
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7 p& @( \# Z4 ?* c0 D1 ?7 pMonitoring Clinical Trials for Adverse Events + u! U' [  K8 _
Introduction
; T9 o9 @" D* p8 e9 ?: [$ u9 lDesigning for Safety: Antibiotic Rash Example  u: X4 i- Q2 G6 C) ?; M( H
Designing for Safety: Hypokalemia Example
5 R4 t  Q% b0 A. Q7 J, O( ZDesigning for Safety: Hypertensive Rebound Example 2 `9 K9 W: n2 u- ^
Premarket Approval Trials: Designed for Efficacy
6 Q7 f* X1 T+ Z: F3 ^Premarket Approval Trials: Quality of Adverse Event Information
. m5 a* U' g, q$ j& s2 h* A( CMonitoring for Safety
& ^2 L$ E$ R6 LStatistical Methodology: Individual Trial' {  f" Y8 I8 F8 S- ], S
Example
! r+ X) H* v9 y3 q% BStatistical Methodology: Across Trials
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, H" q% `$ x# i8 WIndex- j( J$ t! `  c+ t4 L3 B4 ^' Q

; G- B" Z4 ~, j" `References appear at the end of each chapter.
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% R; X: R4 W# U5 _0 ]8 }; CAuthor(s) Bio
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- k& B0 C9 ^# \3 a" d9 i9 `Karl 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.0 j0 l( A4 V) m

/ _. h& O' |* W; a% zDin 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.# ~, U' [# C  \. h9 ]) k& j
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( R* N7 A( T+ a1 F; ?$ \ Clinical Trial Methodology (2010).pdf (2.52 MB, 下载次数: 82)

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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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