公卫人

 找回密码
 立即注册

QQ登录

只需一步,快速开始

不劳无获:如何获取钢镚? 因为论坛,所以相逢。 捐赠百科答题至尊

公卫考研:一起风雨兼程 因为梦想,所以努力。 真题答案政治英语

职称考试:诸君逢考必过 因为热爱,所以执着。 模拟考场技能执医中级

查看: 1537|回复: 2

[分享] Clinical Trial Methodology (2010)

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

注册后推荐绑定QQ,之后方才可以使用下方的“用QQ帐号登录”。

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
61yEAoXGxnL.jpg 1 i* u- x) ?* {+ @

: z8 w7 i0 H1 ?+ OTitle: Clinical Trial Methodology; M+ |' w$ z% F9 `1 \- C' Q  S
Author(s): Karl E. Peace, Din Chen
1 r6 a' q# v% H' C* t! B# s, a" hSeries: Biostatistics Series        , o' w/ d- m# Y3 G  m& L$ @7 Q. C
Publisher: Chapman & Hall CRC. O; W, N) a5 C
Year: 2010       
- z% w) {6 p# J2 @" X" K1 \Edition: 1. k& h6 X( G) h
Language: English3 f' V0 Z3 B: a  ^
Pages: 4206 x7 Z& n5 O3 w/ U# h' W
ISBN: 1584889179, 9781584889175, 1584889187, 9781584889182
& V/ B5 Z: |) S6 ^" `Size: 3 MB (2647392 bytes)
/ z3 O$ y1 P: j2 V) s& T- x5 f& U, WExtension: pdf

1 A- N$ D2 l" h/ K* C
, W3 D6 n0 o* o& N6 p6 T$ g9 @* n, B$ \: w5 X6 c/ E. ?
Features7 e! f* b! u8 X2 C# N0 u0 _

: ]$ o! L$ o) N7 ^. ~6 i
  • 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
    2 j  w; f5 Z" D* L9 x

5 |4 A" F- f/ F, O: l; h3 K3 ^) c8 ^, V! V. u, }

: E5 N- t+ s- ^Summary
% k9 H2 d- t) q4 ~/ l% E* C
9 q# K- |' ^( w- ?! \4 ?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.$ z% S, j. Y! \  T
" q$ v! j# S% Z/ i6 I
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.! e7 g5 R/ ~: r

" w! X$ R  E1 T1 G; d! _/ S) k3 |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.4 U0 I2 U1 a, v& [1 p  e
: |8 V" Y: J# Q7 W

' e, }0 N# ^( R/ _$ T6 ^2 K4 |+ C" \# s
Table of Contents
5 u1 B/ k4 W- C: @. n' A& C# F$ p' h: v. H) R1 E
Overview of Clinical Trial Methodology
3 u4 r4 I7 J/ I  O, X2 n& [Clinical Trials
) y+ M. i' A4 @; _7 P( nClinical Trial Methodology
; o0 e: B: g5 L# ~Summary of Clinical Trial Methodology
5 e: X+ `) ]: A' i1 A4 u* L3 J+ D8 G' r' G% ~% R8 U
Overview of the Drug Development Process and Regulation of Clinical Trials & z( e6 C" ^9 m  M; m$ w5 Y7 k
Introduction
* B" o  Z# O( ^8 r) y6 mThe Drug Development Process6 M8 L7 d. _8 n
History of Drug Regulation# X  K9 m: |6 n/ `, d9 L: L
Principles of Adequate and Controlled Investigations
' g) U" T; K* L" q3 ~% JContent and Format of the IND7 o: f9 `. e" p* X3 J  C
Content and Format of the NDA0 e3 c6 `6 M  t2 T8 }# l* e
Organizational Structure of the FDA
8 E9 P  l* G# I! `; fThe FDA Review Process
% W8 K2 v) ?; gLabeling and the Package Insert 0 f1 Y, S$ H0 T
Pharmaceutical Company Organization and Role of the Biostatistician
( z. X& a( Q' V4 G* {! U
: j( q; n" |4 R6 P; I3 GEthical Considerations in the Design and Conduct of Clinical Trials
% n0 Z, X( }& I5 d2 e' DIntroduction
% u/ [! v# W, B8 B5 QHistory and Evolution of Ethical Considerations in Clinical Trials: Key Milestones# m) P% f9 s" Z6 n% I
Independent Review Boards
5 U4 x: j& S: NClinical Trial Ethics: Who Should Practice?* D* L6 c2 U; {$ c$ m7 ~& k
Informed Consent, Sample Size, and Power
9 ?0 T3 ~! O7 I6 TCommon Ethical Principles of Various Codes and Regulations
  b0 R* p. b4 K$ B( T& i, Y
# J& Y+ Q2 }! D8 h- F0 N; MSample Size Considerations in Clinical Trials Pre-Market Approval
. Q% C3 w  u" |; Q4 W5 d/ G; cIntroduction
  G4 W' |: r1 ]$ G4 x9 ?3 H& B5 dPhases of Clinical Trials and Objectives & {, y4 r+ @: s1 Z/ W3 {
The Clinical Development Plan: Pre-Market Approval% B" S1 `4 d% p
Sample Size Requirements
. [- z, l4 R: V/ W, Q8 W  |) r" n. Y" {Examples7 D( x* U. @3 F& F% ]8 O8 l5 e/ Y
Philosophical Issues
( f* n! X- ^( B8 l* M" g( {
0 V/ O+ L) W0 RSequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials
/ D. M; z; c0 @; a0 p8 Z3 rIntroduction
) K0 s: g, @6 p! {) ?0 b2 u1 USequential Procedures* y. K7 P! `9 b- N# }+ ^# |1 G8 }- B
Group Sequential Procedures
$ a4 b& w, H7 Z: y. hStochastic Curtailment$ L$ i9 [1 V! G' r& ?/ t7 f
Adaptively Designed Clinical Trials
* I/ W% o( H. L( r) g( y! t9 i
# P1 H$ Q' r1 `( @0 b3 I" b$ {- lBiostatistical Aspects of the Protocol
- Z. G# p8 A/ G' S8 S1 sThe Background or Rationale ! ~5 g; F, J: S( Z5 j
Objective
2 x% K5 b8 ~; H) o+ V/ M$ C2 kPlan of Study
5 L+ [; \2 ]. i4 ?0 V+ oStatistical Analysis Section
! e* P4 L" Z' P  ~2 B0 v( u; oAdministration  W* N4 v6 R2 O2 U" }9 B1 s4 @0 o
Protocol References Section
! Z  [; }3 d! p4 q; u' V4 t$ J
3 [. v$ i2 n( [0 NThe Statistical Analysis Plan
' l  ]8 \+ q7 G  I0 XIntroduction" m) Q2 X, _. G: Y0 |. g$ t
Protocol Objective
* U5 I; G' q9 |7 QEfficacy Data Collected and Protocol Schema
* B4 l1 S0 I6 f4 H% o5 l9 B& _Primary and Secondary Efficacy Endpoints# {& g' ^& G0 m4 S; w; Q6 D% t
Objectives, Translated as Statistical Hypotheses
) M; }/ l, y; v, Z. NProtocol Design Features
( a. J( _, |1 I6 XStatistical Analyses
- K" P% L- d1 p  J( I/ A. n% K" ^' t) ^/ G+ B
Pooling of Data from Multicenter Clinical Trials% T% }8 k+ v) j; ~* _
Introduction
% F% ^+ A& N4 @) `; RMulticenter Clinical Trial Experimental Setting $ y6 ~  [3 \( |: n: H
Pre-Study Planning   t4 p& C( P4 J5 G' S
Multicenter Clinical Trial Conduct
9 s: j2 k& r* i/ @# H9 cBiostatistical Analysis, \$ u! {- j7 f( S
$ w$ k, q3 O* \% s8 W8 |( i/ J6 {+ L+ l
Validity of Statistical Inference3 \/ [: y/ `0 ]  N
Introduction. Z6 K1 N1 I% _* ~; v( l' W
Planning the Investigation
: v& t. q5 s: R' O3 c8 O4 ?6 rConducting the Investigation
7 f& N" O% ]: u- |4 bStatistical Analyses, Interpretation, and Inference
1 ]- S; T: q3 D$ `- }5 ?Reporting Results of Investigations
2 `0 p- o+ B) v* o* U+ H% ?7 J3 Q# j) {4 z1 ~9 N2 N% v
Bioequivalence Clinical Trials
; i4 l0 v/ Z$ R8 `. M9 v3 b9 w4 DIntroduction
" n8 o# T; h: e$ hAbsorption, Distribution, Metabolism, and Excretion (ADME) 2 f$ C. y+ N9 g- u0 a. H/ g3 z
Bioavailability
( z8 ^' e) f# r! P+ V" }Factors That Affect Bioavailability  y- @) _6 m* a' ]( q  `
Blood Level Clinical Trials
5 d9 Y* Q# }- \" ]2 d% DBioequivalence
5 D5 Z  Z6 Q* S8 wDesign of Bioequivalence Trials
" I3 v  P+ j9 {: @4 E2 E4 M* M& P. PAnalysis of Bioequivalence Trials + ]! |  l% T/ S7 W
Analysis of Ratios4 ~% b9 O& _  ^& y) v) {
Pharmacokinetic Models ' p4 C$ n# ^# A" ~. `5 e- G
Support of Bioequivalence Trials in the Pharmaceutical Industry
3 a8 x7 A4 M+ Y  k) E$ m8 BExamples- m7 j8 t" u% h! a; ]/ R
  W0 d6 h, r7 |/ I( Z5 s' u/ J( t
Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina - M4 C$ _) r6 `5 q, {
Introduction1 \' }# b5 ?: r: r
Overview of Response Surface Methodology
+ y- f- [" U/ jFull Quadratic Response Surface Model' m7 E% p) F! C7 h, B% m0 d
Phase II Clinical Trial Program in Stress Test-Induced Angina
4 _# s$ a1 y) s, }. D' {
+ d$ K* z, _! X& dConfirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial
! I5 v: m- f5 R  L: ^" mIntroduction. L5 |* H& N. Z9 D8 M# x8 W0 ^
Background
1 ]% z6 E/ m5 M. o9 l# EObjective 2 w0 z# O& V+ v
Designing and Planning the Investigation
0 U: U7 ~) A: Y$ MConducting the Investigation % p" M6 o; }% M
Statistical Analyses% K, d! D: o/ o4 M
Other Considerations
4 I; _# q9 ^; mInnovative Aspects of the Clinical Trial Program
0 d5 @1 y; r" K  a$ f0 E6 F2 i5 ~& f0 p5 F! L% Q. Z0 a
Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration . D; H+ Y4 z( @, P' n! c4 i
Introduction1 j8 _- K2 z7 @2 F
Rationale
6 x# x5 U# i: J  \3 HThe Protocols
8 k  x# C( F" {: NMonitoring and Data Management& N" K/ g+ K5 U& W0 m
FDA Meeting' E% J* ?, u' ^% {  @. m
* F  \' u  \4 X- y8 k( _7 e) i
Clinical Trials in the Treatment of Alzheimer’s Disease Based upon Enrichment Designs8 L7 v' t: y; G8 d
Introduction
% u% L# A# Y+ |6 DEnrichment Design Clinical Trials 2 z3 R3 R  `0 L+ K
Objective
2 g6 u; |* q8 IPrimary Efficacy Endpoints
5 D0 N( W+ m0 LSample Size Determination
. b& P7 H$ J2 p$ Y  qStatistical Methods
% u0 R  ^# H3 s+ g& s: d. AResults. d/ t- J+ l/ x5 I$ f
: F2 O  R, ~; V
A Clinical Trial to Establish Reduction of CHD Risk
5 W9 q1 H# h; \Introduction# b& \9 k- K# F! y* B4 B
Objective
3 [& v- N6 \9 b1 |& `% UDesigning and Planning the Investigation
9 B: e: z2 Z& r) b% O5 V. Q  AConducting the Investigation
% `/ s8 Y9 q% m4 W" Y/ ]/ c( j7 |Data Management 8 A, v. }' u- E( Q6 m5 X
Statistical Analyses0 V- S4 x, F$ _( q
Results
  B' D; C! @. E9 JSummary7 ~/ u$ f8 z+ ~' |0 C) H
( F6 _5 X  X& W! |+ t3 L7 t
Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder 8 r7 @( j: G, `
Introduction& z% @9 l! w. A( Q. B  M4 |1 E
Design of Pivotal Proof-of-Efficacy Trials
8 w; ~  u1 M! j; h: T6 eTraditional Statistical Analysis Methods
/ D, b6 l4 D% h2 R* \  hOverview of Efficacy Results of the Two Trials ' K* T0 }0 n9 j$ v( p) D, C9 ^" m
Alternative Design and Analysis Strategies
7 |- \2 y3 X2 r, h/ G$ T$ p: A
Combination Clinical Trials
8 G; d( ^! ]$ LIntroduction
9 o3 P5 I, m, gTwo-by-Two Factorial Design
2 @5 c* r- ~0 o8 L) nEffectiveness of the Combination
' e# H5 g! j9 S6 x$ D- r8 c! a5 HContribution of Components to the Effectiveness of the Combination * o9 k. R! K. n7 m6 p5 Y- t
Factorial Designs in Other Clinical Development Areas
8 b; K3 W: |: x0 VExample 1: Actifed in the Treatment of SAR Following DESI Review9 K) C0 s9 n: X( o$ w
Example 2: Crossover Trial of Actifed in the Treatment of SAR: _/ ?- E# p, H( O$ a
Example 3: Parallel Trial of Actifed in the Treatment of the Common Cold
. J: f- G! f7 e- h/ ]" b. t
/ E- l4 b- |: ^# J4 X1 }4 C) ?2 AMonitoring Clinical Trials for Adverse Events
& S# k  \# w) l# P5 FIntroduction- ?3 O2 |9 [1 a% Q4 ]0 a
Designing for Safety: Antibiotic Rash Example& K7 W* P+ `# `0 h6 M
Designing for Safety: Hypokalemia Example ) K  @. |, }% I1 S7 E* L
Designing for Safety: Hypertensive Rebound Example & i# s6 J6 [4 R* t( ^: l
Premarket Approval Trials: Designed for Efficacy
! f, S: i$ ?+ i8 J2 VPremarket Approval Trials: Quality of Adverse Event Information
% h' I; L# V! ?: p( D+ }$ bMonitoring for Safety/ H# R& p9 Z& R
Statistical Methodology: Individual Trial; {& B+ E. w8 s& g  a8 N5 ~
Example
! P! G9 T2 ^" v1 e3 i0 r4 [Statistical Methodology: Across Trials
6 q: u& e- S9 l  Q* V  }9 T- m1 Z2 G5 a9 u9 U
Index; r3 a& e; B+ J) W2 {, k

4 v# B( Z0 U" E+ t' dReferences appear at the end of each chapter.
( `" a6 H' C& P" W3 x; |" c* L, x' a$ @
  w8 w6 ~) Z* c9 [% p9 l
) f1 x0 N' u+ `. h* v, S
Author(s) Bio7 [  [% v# c6 e/ H0 B

4 E  ?2 Q: o2 T: fKarl 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.
3 J, i! y2 |4 j3 W$ e- K- t3 Y- Q. h$ t0 M0 I) y) K7 Z: J
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.
7 I3 w, l, u# }  u5 u: ?2 G
- d; ]* F& P" N: L( j$ {" r2 a% H7 M4 `, h$ H2 R

  l6 L" j+ f/ ] Clinical Trial Methodology (2010).pdf (2.52 MB, 下载次数: 78)

本帖被以下淘专辑推荐:

tljuly 发表于 2017-12-23 23:08:15 | 显示全部楼层
好书!!多谢分享
回复

使用道具 举报

芬2012 发表于 3 天前 | 显示全部楼层
已下载,感谢分享
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

提现|充值|关于|接种|公卫人 ( 沪ICP备06060850号-3 )

GMT+8, 2018-4-26 23:41 , Processed in 0.245113 second(s), 39 queries , Gzip On, MemCache On.

Powered by Discuz! X3.4

© 2001-2017 Comsenz Inc.

快速回复 返回顶部 返回列表