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

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Title: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
Author(s): Tom Brody PhD University of California at Berkeley
Publisher: Academic Press       
Year: 2011
Edition: 1
Language: English       
Pages: 638
2 ^3 y0 \% _$ K- v$ l0 @3 N1 E9 JSize: 7 MB (7293100 bytes)       
Extension: pdf

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.
Provides 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
For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn

Table of contents :
  d. [9 j/ T4 @" [: N- X; YContent:
Front-matter, Pages i,iii
% q7 F3 d. W5 z# d. q5 sCopyright, Page iv
Dedication, Page v
+ A/ \! Q9 r7 X% S& ?* }1 vAcknowledgments, Pages xv-xvi
Preface, Pages xvii-xxi
: n" R( O2 h- y# y- hIntroduction, Pages xxiii-xxv
  a% o6 t8 b, ]2 n. A( ^Abbreviations and Definitions, Pages xxvii-xxxi
Biography, Page xxxiii
Chapter 1 - The Origins of Drugs, Pages 1-15
Chapter 2 - Introduction to Regulated Clinical Trials, Pages 17-50
: S3 j- ^" D  y. X: T4 F* LChapter 3 - Run-in Period, Pages 51-61
$ t! r: M  C$ \$ B9 B: z6 QChapter 4 - Inclusion/Exclusion Criteria, Stratification, and Subgroups – Part I, Pages 63-89
7 y4 v+ u  b2 a4 M0 n: c( k+ EChapter 5 - Inclusion and Stratification Criteria – Part II, Pages 91-110
Chapter 6 - Randomization, Allocation, and Blinding, Pages 111-129
; B/ X9 X* H0 I! p: |$ VChapter 7 - Placebo Arm as Part of Clinical Study Design, Pages 131-141
: |" D4 F5 t* p  LChapter 8 - Intent to Treat Analysis vs. Per Protocol Analysis, Pages 143-164
6 l' Z! l+ j9 i% p2 U" W, k6 sChapter 9 - Biostatistics, Pages 165-190
Chapter 10 - Introduction to Endpoints for Clinical Trials in Pharmacology, Pages 191-195
; j# L- s+ ~2 X3 J( K9 gChapter 11 - Endpoints in Clinical Trials on Solid Tumors – Objective Response, Pages 197-211
2 O- ~$ x4 ?0 X$ f# m5 u# X2 GChapter 12 - Oncology Endpoints: Overall Survival and Progression-free Survival, Pages 213-236
Chapter 13 - Oncology Endpoints: Time to Progression, Pages 237-250
/ w3 ~! l: O0 d; EChapter 14 - Oncology Endpoint: Disease-Free Survival, Pages 251-261
Chapter 15 - Oncology Endpoint: Time to Distant Metastasis, Pages 263-270
& A, B# U7 Y/ T; jChapter 16 - Neoadjuvant Therapy versus Adjuvant Therapy, Pages 271-277
+ W3 q/ d+ b1 e. X$ u6 w6 F2 FChapter 17 - Hematological Cancers, Pages 279-325
/ ^; h! x) _1 T6 [0 d# F' _Chapter 18 - Biomarkers and Personalized Medicine, Pages 327-353
Chapter 19 - Endpoints in Immune Diseases, Pages 355-367
Chapter 20 - Endpoints in Clinical Trials on Infections, Pages 369-382
$ W" U. r9 w# f3 ~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
! }6 t: J9 o8 }8 `( q  TChapter 24 - Drug Safety, Pages 415-469
Chapter 25 - Mechanism of Action, Part I, Pages 471-491
9 d9 L6 B$ |. W3 RChapter 26 - Mechanisms of Action, Part II – Cancer, Pages 493-501
Chapter 27 - Mechanisms of Action, Part III – Immune Disorders, Pages 503-515
' B# ~0 j8 B: f, ?# [Chapter 28 - Mechanisms of Action, Part IV – Infections, Pages 517-533
Chapter 29 - Consent Forms, Pages 535-559
8 Q' J3 R+ V" I, XChapter 30 - Package Inserts, Pages 561-575
Chapter 31 - Regulatory Approval, Pages 577-605
Chapter 32 - Patents, Pages 607-623
Index, Pages 625-638
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& h5 r- u: I7 |7 t( t7 U Clinical Trials Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and.pdf (6.96 MB, 下载次数: 175)

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赞一个！

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。

怎么下载不来

哇，太棒的书！谢谢楼主分享

先仔细读读再说。