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% h& V) }& R1 SA valuable new edition of the trusted, practical guide to managing data in clinical trials
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1 X/ F. L8 X# A* pRegardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. + D- V J. B7 u$ |4 e
+ W2 {1 W$ I; [/ xWhile maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.
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z1 h+ V+ G% _4 u6 l" dNewly featured topics include:
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The growing availability of "off-the-shelf" solutions for clinical trials
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Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry / b) o. E8 P6 s6 f8 J
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The increasing use of the Internet in the collection of data and management of trials
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Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines ! k5 e( y# W1 Q) M" ^
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( ?9 O& |9 h+ y8 n1 \* v/ ZDevelopment of Standard Operating Procedures for the conduct of clinical trials
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Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.
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1 D0 C0 b. b* fPreface.
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Randomization and the Clinical Trial.
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1 [% B* J; O! d) M0 Y( CIssues in the Design of Clinical Trials.+ }4 r5 `1 x) [/ h+ |8 E7 {$ w
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Randomization for Balancing Treatment Assignments.
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Balancing on Known Covariates.
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) G6 z! x* s2 L2 tThe Effects of Unobserved Covariates.! m0 K7 P( w% u% j
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Selection Bias.
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Randomization as a Basis for Inference.4 A: q5 j- F- M& k! Y" ^8 X. H
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Inference for Stratified, Blocked, and Covariate-Adjusted Analyses.
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" e$ V- L/ F8 c9 A) lRandomization in Practice.' h& z- q" R- [5 g G$ ^: H4 Q
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Response-Adaptive Randomization.
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# {: l: L9 \; N1 q0 JInference for Response-Adaptive Rondomization.8 y( v9 t4 {; w% @3 D) n; R
8 J7 K- f* C" D# p& Q! eResponse-Adaptive Randomization in Practice.
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Some Useful results in Large Sample Theory.- Z K* s7 s. M' [% u$ D
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Large Sample Inference for Complete and Restricted Randomization.
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, b7 y* V; P1 ?2 H) J2 @+ G. {Large sample Inference for Response-Adaptive Randomization.* i, L& ~- H- e, ?
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Author Index.1 P" Z5 l0 c2 c5 Q$ o
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Subject Index.
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A unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications
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The role of randomization techniques in clinical trials has become increasingly important. This comprehensive guide combines both the applied aspects of randomization in clinical trials with a probabilistic treatment of properties of randomization. Taking an unabashedly non-Bayesian and nonparametric approach to inference, the book focuses on the linear rank test under a randomization model, with added discussion on likelihood-based inference as it relates to sufficiency and ancillarity. Developments in stochastic processes and applied probability are also given where appropriate. Intuition is stressed over mathematics, but not without a clear development of the latter in the context of the former.3 `1 [: L: w3 o2 {2 o" {. A6 [' C
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Providing a consolidated review of the field, the book includes relevant and practical discussions of:
& K$ U, Y# ]6 s3 U* The benefits of randomization in terms of reduction of bias
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! p6 j S/ N9 K+ B. ]+ L& N* Covariate-adaptive and response-adaptive randomization# _. P) m P4 Q u) u
* Current philosophies, controversies, and new developments9 L% E" `2 e6 V2 V9 O3 I% F8 @
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With ample problem sets, theoretical exercises, and short computer simulations using SAS, Randomization in Clinical Trials: Theory and Practice is equally useful as a standard textbook in biostatistics graduate programs as well as a reliable reference for biostatisticians in practice. 1 e: _6 _4 G7 v9 w+ E( }# D, B
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