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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 Methodology3 m- @$ A9 R2 ?4 W" k" H7 K0 N
Author(s): Karl E. Peace, Din Chen
+ w1 Y# Y2 X2 f6 ]" P5 d# {( qSeries: Biostatistics Series        2 N5 e* {) z, W  x( d- {5 r7 y
Publisher: Chapman & Hall CRC
0 a9 d- i- w5 _7 B9 a/ T; LYear: 2010       
* @- S3 Y, i3 Z9 g5 x5 J; kEdition: 1! j2 l  n2 }: l* p. \
Language: English5 L5 u, t6 f, V2 h& W
Pages: 420" ~+ W8 b. @( t: o0 \& j/ a7 _
ISBN: 1584889179, 9781584889175, 1584889187, 9781584889182
3 l4 l! L# q; m9 O8 U( ]Size: 3 MB (2647392 bytes)
  O8 r  K# d% ?Extension: pdf
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Features
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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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0 i) o; N5 W  m& d1 L" @Summary- c, Q: }7 e, a, a1 Q

  _9 n! R; I% ?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.5 _9 _0 k5 d& I- Z/ \2 F+ E; q, p
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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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& W; v, O! H% sAided 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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  W5 d1 y% K0 G* s5 q/ T: j) J" n9 P2 P  U2 b& Z1 x. H  N
Table of Contents/ f5 `6 I' t. u& d" p

+ N* f2 Y! A% T4 s% F( Q$ _Overview of Clinical Trial Methodology % g5 G/ I# w2 p6 L5 x. g
Clinical Trials
6 L. C  o" O' t; ~Clinical Trial Methodology4 I" L5 s7 w# i. \
Summary of Clinical Trial Methodology/ J; s0 S' }# s) N  `& [

* @5 w4 b* m8 {1 B# |Overview of the Drug Development Process and Regulation of Clinical Trials
& E/ G  R1 ~8 Z, J5 g  `# [Introduction( M% g1 P  @+ ~1 r
The Drug Development Process& M# J/ [% t  W( F3 w- v
History of Drug Regulation
5 s% u% `. k) F' a1 K! a8 UPrinciples of Adequate and Controlled Investigations
/ Q. W2 ~3 R9 }* y8 _7 f; WContent and Format of the IND) Z+ m& v9 r; O, F3 L6 v+ `! ~
Content and Format of the NDA
* J+ _, {& q  r$ @$ E# a- ]& U' G: h; XOrganizational Structure of the FDA4 x" c& }9 F1 f* h
The FDA Review Process
9 L# K! [' X+ [9 Y2 V& K2 @Labeling and the Package Insert 0 i: b; {* B! x4 ?6 y6 B8 w5 a
Pharmaceutical Company Organization and Role of the Biostatistician
. F3 [9 s4 h: t" t) u5 f6 w! g9 B/ r7 }
Ethical Considerations in the Design and Conduct of Clinical Trials / c# F5 A1 q6 b+ A) z
Introduction
" ~* u, G% n, z) }& |; Z0 i+ W( ~$ O  XHistory and Evolution of Ethical Considerations in Clinical Trials: Key Milestones
5 s4 [9 i; @  @. O7 YIndependent Review Boards6 K6 z3 G# f5 c1 W) P
Clinical Trial Ethics: Who Should Practice?
! U1 A, \6 m; H5 K) s' b. A) fInformed Consent, Sample Size, and Power
+ z$ I  Q# X- @$ h" X% s2 DCommon Ethical Principles of Various Codes and Regulations
( ~1 V7 l* ?; V7 ?1 ]  Y
; i) e2 p. J+ s& I) BSample Size Considerations in Clinical Trials Pre-Market Approval , y8 D: I/ h- h1 j/ E  ~0 C
Introduction7 T# a& J5 V5 c5 ?1 `% N! d' ~
Phases of Clinical Trials and Objectives 4 B3 i6 N% N6 k4 k/ \: p
The Clinical Development Plan: Pre-Market Approval
, n' X* `- A: \; vSample Size Requirements) l# t2 d. |# y$ `4 t8 t' T1 _
Examples
2 P# z/ `. K1 A( D. q2 IPhilosophical Issues4 G2 u) Z' x0 c' L& w) n0 G8 \

0 p, a, R& {% S: N/ hSequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials
/ ~3 f+ d$ C$ `7 G0 ~. BIntroduction+ \0 |+ ^# u  B9 l5 p& ^# v2 G
Sequential Procedures. X3 x& G2 V: {8 K+ A
Group Sequential Procedures
: i2 c3 Q3 t) bStochastic Curtailment
) z5 j9 b# k: |* k* O, I: R; X+ h+ xAdaptively Designed Clinical Trials- R" R$ s  U3 i+ t6 f! b; b# s
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Biostatistical Aspects of the Protocol " ]4 t0 q4 K4 v2 n$ K3 L- u
The Background or Rationale 4 a2 E0 ~# [0 z/ }2 _% \5 Q0 c
Objective
1 X# s+ J/ y+ r2 `0 \/ pPlan of Study
$ w6 w/ c: G' a5 zStatistical Analysis Section8 r# H' x, k% L
Administration  m9 j6 ?$ Y* T  e# m& B6 f  {
Protocol References Section% X5 W9 o2 h( n% Z8 `: |
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The Statistical Analysis Plan
2 ]1 Y4 |/ M) g, W: wIntroduction
: e: w+ V- [+ L- s' ^- v2 fProtocol Objective( z+ h  y1 c8 c9 n2 _
Efficacy Data Collected and Protocol Schema
- V' m; m& _8 G& M' mPrimary and Secondary Efficacy Endpoints
- V; Y2 {% P1 a' U1 gObjectives, Translated as Statistical Hypotheses
& W" b( _+ [- }9 zProtocol Design Features
8 F' k! y$ M( d  PStatistical Analyses  I3 [! m+ A, _$ }; |

, P. M: f4 ^/ T( ePooling of Data from Multicenter Clinical Trials0 q  R, o8 U! Z2 K
Introduction
0 F) |$ ^- J$ E+ _. _Multicenter Clinical Trial Experimental Setting , O! M+ i; q9 ~8 x0 S& I
Pre-Study Planning & Y& O5 ^$ m9 q  k
Multicenter Clinical Trial Conduct - ]! m3 Y* B. c8 @* g& U: Y2 u
Biostatistical Analysis
& e7 ]5 A5 |1 [5 A# B- s8 W9 O3 }' b) _5 f& q
Validity of Statistical Inference4 E; O, z; \+ |$ v7 v
Introduction
* Y1 J) w* l) ?$ `8 z% tPlanning the Investigation" d; g8 ^) Y2 N
Conducting the Investigation 5 \3 {) D6 Q9 s: f/ J% u) _
Statistical Analyses, Interpretation, and Inference
6 B, k  m* S* r0 ]' `: `Reporting Results of Investigations$ @  P. @- C. H5 l
+ L' K8 C5 e5 b. r
Bioequivalence Clinical Trials
1 t" N. T1 S1 DIntroduction* G0 c1 n3 i: s. X5 Q( j
Absorption, Distribution, Metabolism, and Excretion (ADME) - H8 v; j( i3 d* u; k
Bioavailability 4 m: D! S8 a( m: P) J& ?
Factors That Affect Bioavailability* {, c) ^9 x5 m+ W
Blood Level Clinical Trials
) ?; B8 P' F9 B+ @) u5 v; z* TBioequivalence1 q; Q" w2 g+ x
Design of Bioequivalence Trials
: |7 z9 n- I$ g0 s, ^) e' E  LAnalysis of Bioequivalence Trials 6 ?6 \+ h0 ]4 m6 G8 ?
Analysis of Ratios
& y% H1 h0 }% u  S( L0 @3 m' h" FPharmacokinetic Models
) {( N3 }8 ^" U1 }/ f- o" QSupport of Bioequivalence Trials in the Pharmaceutical Industry
6 `2 F6 B: i' k. C& F1 N2 b$ ?Examples5 }7 \* N, v" v$ V- ]
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Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina
: @* P3 {. N8 [4 i  @/ r3 f( d' iIntroduction+ Y# v6 @. G/ R1 g* ]
Overview of Response Surface Methodology: ~/ `3 Z! B/ r3 R& N5 h( f
Full Quadratic Response Surface Model
. {/ L" c, E/ Y  q9 [# l$ V) h( H5 APhase II Clinical Trial Program in Stress Test-Induced Angina
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8 ~' v, x8 ]# M. b3 \! i4 f" r" sConfirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial + U/ k4 m0 _% M) h+ N
Introduction, z+ V' x6 H' q  A' p8 [
Background
- k. }/ }* e8 Z0 G2 d! M4 BObjective , v3 }% S2 s$ _" Y, X
Designing and Planning the Investigation4 L" t5 u) n3 J3 w1 G' ^
Conducting the Investigation
5 o3 m3 E0 C+ oStatistical Analyses0 D; r+ S) x# c* }+ N
Other Considerations0 }, z1 D! C5 l; i
Innovative Aspects of the Clinical Trial Program5 _& {/ F$ l; {, T7 M" E
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Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration 1 Z8 b& j+ e4 d. a* a* \! R
Introduction* ]! l: X+ l; y2 K
Rationale & d" Y* ^! w5 Y1 a( w; a* h
The Protocols
/ l; g$ C5 z  k( q+ NMonitoring and Data Management5 ~+ F; K' G' U; E3 Q6 M
FDA Meeting! ^2 L0 ~2 h% U& @

% h9 Z% r6 |# L( Z: BClinical Trials in the Treatment of Alzheimer’s Disease Based upon Enrichment Designs
) ^# H& e* q6 m; l7 ~' uIntroduction
5 y+ e5 q4 T/ F3 Y  d" DEnrichment Design Clinical Trials
" j7 [, D" e, P2 Y+ `( vObjective
" {! b0 n* o# Z. ^% qPrimary Efficacy Endpoints
9 a$ V0 j  N; U9 }Sample Size Determination" b1 S: Y  r2 ]. z% X1 S$ B
Statistical Methods; Q6 F; X2 ]3 t, y/ d" S) G
Results  t# m0 B) W. ?9 O2 {
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A Clinical Trial to Establish Reduction of CHD Risk
, B6 R6 D# i( p* U/ XIntroduction
4 T: [  `4 e/ {- q) J2 c3 wObjective , \! u! J8 \* G! e# A3 R; @$ S
Designing and Planning the Investigation
( H1 s5 P! O5 w& SConducting the Investigation % L3 S8 k, o: X* _
Data Management
8 M0 h, w1 R2 Q- BStatistical Analyses
9 e% v$ M$ E( `* A7 _. hResults( L4 }& y7 M# O3 y1 |  a
Summary0 X2 V8 r6 o) y$ M

. O& q# b5 u) z  |8 e+ _Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder
) c& t/ ?4 d1 f& UIntroduction9 m2 t, z4 I- V
Design of Pivotal Proof-of-Efficacy Trials
' y9 _% ]  Y  z1 z+ @4 m& uTraditional Statistical Analysis Methods
+ p4 z; f  i; nOverview of Efficacy Results of the Two Trials
: b5 y- q0 L7 [6 u5 R, R% EAlternative Design and Analysis Strategies3 f& s: L: s1 |, A6 D0 `8 k
) Y4 w0 H, A$ k9 F  |! J; Q
Combination Clinical Trials
& p  X6 Y" {! k0 i2 HIntroduction* r" d2 @, k) Y& F0 R
Two-by-Two Factorial Design
' W% S8 D; G% ~' GEffectiveness of the Combination
% E1 K3 _5 I% C9 E. ^Contribution of Components to the Effectiveness of the Combination 7 I- }/ _; Z# ?
Factorial Designs in Other Clinical Development Areas
# n+ [" X/ F1 U/ c  v& j4 p* Q- GExample 1: Actifed in the Treatment of SAR Following DESI Review: `) ~, D" E5 C2 M' G; a: ^+ m
Example 2: Crossover Trial of Actifed in the Treatment of SAR; }4 d; E: G+ b7 G3 G: g
Example 3: Parallel Trial of Actifed in the Treatment of the Common Cold
& {( H* [2 ?& W" }; l/ o/ |$ ^6 M# b/ g9 K9 ?: V6 P
Monitoring Clinical Trials for Adverse Events ' E: P# e9 @( C
Introduction
2 L) o) R# ~' |$ W* d  Y( a  ?Designing for Safety: Antibiotic Rash Example; X# @3 l, l. h' C6 D* s! }
Designing for Safety: Hypokalemia Example ) y" @& F; v6 x9 ]1 |3 E! B, K
Designing for Safety: Hypertensive Rebound Example ( l. K& V: Z+ Z$ e0 q% _
Premarket Approval Trials: Designed for Efficacy
% C5 n2 H& k' _6 ?. l1 d( l$ SPremarket Approval Trials: Quality of Adverse Event Information/ t* t: i6 z& d0 {
Monitoring for Safety  E. D# D1 M) \  x$ c2 T
Statistical Methodology: Individual Trial
' l, l5 x0 O3 E1 }. b, b4 a- FExample+ v) S/ \. h8 Q- q9 B+ X7 i4 ?
Statistical Methodology: Across Trials" T' _! s/ \2 l' c3 J$ O1 G+ E

+ g+ [- e9 D1 O& rIndex$ K0 v3 R3 S7 @" {8 W% \

: j1 F9 O5 n6 M  jReferences appear at the end of each chapter.
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Author(s) Bio- s' U, a# w3 X  E2 C7 Z

$ I) H5 t2 ~- d+ k$ E1 {0 yKarl 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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- i& V1 L! p4 j( g' B! |( TDin 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.. D( I. e# F1 v& Y
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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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