Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA

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! I+ v6 J! o7 d1 o( ^Title: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
3 o4 X/ V$ ]* y6 r3 mAuthor(s): Tom Brody PhD University of California at Berkeley
Publisher: Academic Press       
0 |. y2 _& R) Z  k( |" b; sYear: 2011
Edition: 1
) a! [$ g- V" O/ m4 x+ CLanguage: English       
Pages: 638
Size: 7 MB (7293100 bytes)       
Extension: pdf
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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.
% J5 F- R) |5 DProvides extensive coverage of the "study schema" and related features of study designOffers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial designFeatures examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study designIntegrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trialsIncludes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe
; f3 E. v8 N0 [: GFor complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn
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Table of contents :
$ D! S3 v  t" l7 Q  HContent:
$ d8 }& M/ e# T/ M  jFront-matter, Pages i,iii
Copyright, Page iv
( x4 @; c* H7 p* f- ZDedication, Page v
$ `. B/ Z3 ]' h1 H8 EAcknowledgments, Pages xv-xvi
Preface, Pages xvii-xxi
Introduction, Pages xxiii-xxv
+ Y3 v8 w: L2 oAbbreviations and Definitions, Pages xxvii-xxxi
- c, H) E3 ^( V$ ^& L5 G! Y8 KBiography, Page xxxiii
Chapter 1 - The Origins of Drugs, Pages 1-15
7 M1 g8 R# D: u+ u3 a; HChapter 2 - Introduction to Regulated Clinical Trials, Pages 17-50
% q0 R9 a  `1 w6 b' PChapter 3 - Run-in Period, Pages 51-61
Chapter 4 - Inclusion/Exclusion Criteria, Stratification, and Subgroups – Part I, Pages 63-89
( ^* c( Q% ?0 f: J" t% cChapter 5 - Inclusion and Stratification Criteria – Part II, Pages 91-110
Chapter 6 - Randomization, Allocation, and Blinding, Pages 111-129
Chapter 7 - Placebo Arm as Part of Clinical Study Design, Pages 131-141
Chapter 8 - Intent to Treat Analysis vs. Per Protocol Analysis, Pages 143-164
" g0 @1 [; t( ~3 `/ J# C8 d5 gChapter 9 - Biostatistics, Pages 165-190
Chapter 10 - Introduction to Endpoints for Clinical Trials in Pharmacology, Pages 191-195
Chapter 11 - Endpoints in Clinical Trials on Solid Tumors – Objective Response, Pages 197-211
* C! D2 y7 ~; w$ q. kChapter 12 - Oncology Endpoints: Overall Survival and Progression-free Survival, Pages 213-236
Chapter 13 - Oncology Endpoints: Time to Progression, Pages 237-250
: N+ ?+ I8 K+ DChapter 14 - Oncology Endpoint: Disease-Free Survival, Pages 251-261
" O" o* y$ @4 PChapter 15 - Oncology Endpoint: Time to Distant Metastasis, Pages 263-270
Chapter 16 - Neoadjuvant Therapy versus Adjuvant Therapy, Pages 271-277
# B6 y: B. w6 \5 f4 yChapter 17 - Hematological Cancers, Pages 279-325
Chapter 18 - Biomarkers and Personalized Medicine, Pages 327-353
Chapter 19 - Endpoints in Immune Diseases, Pages 355-367
2 y3 p, `4 B! d5 R) VChapter 20 - Endpoints in Clinical Trials on Infections, Pages 369-382
Chapter 21 - Health-Related Quality of Life, Pages 383-400
Chapter 22 - Health-Related Quality of Life Instruments for Immune Disorders, Pages 401-410
Chapter 23 - Health-Related Quality of Life Instruments and Infections, Pages 411-414
Chapter 24 - Drug Safety, Pages 415-469
4 j, ^6 ]+ {7 K) B! O0 D! LChapter 25 - Mechanism of Action, Part I, Pages 471-491
# q! M2 S$ t$ j+ P) z+ t  bChapter 26 - Mechanisms of Action, Part II – Cancer, Pages 493-501
Chapter 27 - Mechanisms of Action, Part III – Immune Disorders, Pages 503-515
. e/ H9 R8 \. zChapter 28 - Mechanisms of Action, Part IV – Infections, Pages 517-533
, o; Q3 `+ }) ~5 K! E% {Chapter 29 - Consent Forms, Pages 535-559
Chapter 30 - Package Inserts, Pages 561-575
Chapter 31 - Regulatory Approval, Pages 577-605
3 |/ ^- \- \/ |( p3 w: v" UChapter 32 - Patents, Pages 607-623
Index, Pages 625-638

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谢谢，这本guideline吧信息整合得很全，值得一读

谢谢，可惜是第一版的。

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哇，太棒的书！谢谢楼主分享