经典临床试验教材：Fundamentals of Clinical Trials (4th Edition, 2010)

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Title: Fundamentals of Clinical Trials
Author(s): Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
Publisher: Springer
Year: 2010       
+ d$ U+ r: l, D4 G: ~" }Edition: 4th ed.
2 C" b2 H) F; G# P4 ULanguage: English       
5 r& A) \1 I1 T# LPages: 408
ISBN: 1441915850, 9781441915856       
ID: 491161
Size: 10 MB (10141362 bytes)       
Extension: pdf

Review:
+ n: Z, C; Q5 A* Z1 v1 N* iThis is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology.
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Content:
% L. u( Y2 F/ ~Front Matter....Pages i-xviii
7 ^" ?4 }# j* j* e5 CIntroduction to Clinical Trials....Pages 1-18
  v6 R/ w! G+ p% D! VEthical Issues....Pages 19-36
4 J+ S# P  m( m: B* Y% o- `What Is the Question?....Pages 37-53
  Z3 t: Q6 i3 ^6 k0 g$ D* Q. p0 vStudy Population....Pages 55-66
: ~8 \5 X& v, C9 F: M) X1 `& F5 w7 zBasic Study Design....Pages 67-96
7 D2 j. r. z- w$ U9 qThe Randomization Process....Pages 97-117
Blindness....Pages 119-132
  J8 ~* r" s- K. k9 G  ASample Size....Pages 133-167
' ?6 ?- q) I! ?5 m2 GBaseline Assessment....Pages 169-182
- S! y& i! q) _0 G% U) SRecruitment of Study Participants....Pages 183-198
; I6 V% B1 e( I: u% R$ FData Collection and Quality Control....Pages 199-214
Assessing and Reporting Adverse Events....Pages 215-231
Assessment of Health-Related Quality of Life....Pages 233-249
Participant Adherence....Pages 251-268
Survival Analysis....Pages 269-291
Monitoring Response Variables....Pages 293-343
Issues in Data Analysis....Pages 345-398
Closeout....Pages 399-410
, e+ m6 n% M3 DReporting and Interpreting of Results....Pages 411-425
5 p7 @$ j* G9 G5 n2 U( ^Multicenter Trials....Pages 427-440
Back Matter....Pages 441-445

需要本书第3版的请点击这里：
  k4 L1 B$ s0 tFundamentals of Clinical Trials （third edition）
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