000			05756cam a22003734i 4500
999			_c7288 _d7288
001			16977581
005			20201019135812.0
008			110926s2012 nyua b 001 0 eng
010			_a 2011036653
020			_a9780195387889 (hardback)
020			_a0195387880 (hardback)
040			_aDLC _cDLC _dYDX _dUKMGB _dBDX _dTPH _dCUX _dCHS _dYDXCP _dCOO _dCDX _dDLC _erda
050	1	0	_aR853.C55 _bM45 2012
082	0	0	_a616.0750724 _223 _bM.C.C
100	1		_aMeinert, Curtis L. _eauthor.
245	1	0	_aClinical trials : _bdesign, conduct, and analysis / _cCurtis L. Meinert.
250			_aSecond edition
264		1	_aNew York : _bOxford University Press, _c[2012]
264		4	_c©2012
300			_axxxv, 665 pages : _billustartion ; _c26 cm
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
490	1		_aMonographs in epidemiology and biostatistics ; _v39
504			_aIncludes bibliographical references and index.
505	0		_aCover; Contents; PART 1. INTRODUCTION; Chapter 1 Introduction; 1.1 Clinical trial: Definition; 1.2 History of clinical trials; 1.3 Trials today; 1.4 Terminology: Conventions and definitions; 1.5 Focus; Chapter 2 The language of clinical trials; 2.1 Introduction; 2.2 On the language of relativity; 2.3 Random: The term; 2.4 The language of the epidemiologist vs the trialist; 2.5 Terminology: Recommendations and comments; Chapter 3 Types and classes of trials; 3.1 Introduction; 3.2 Treatment structure; 3.3 Sample size design; 3.4 Masking design; 3.5 Single-center and multicenter trials. 3.6 Purpose3.7 Treatment modality; 3.8 Big and simple trials; 3.9 Industry trials versus academic trials; Chapter 4 The state and nature of trials; 4.1 Introduction; 4.2 On assessing the state and nature of trials; 4.3 Published trials; 4.4 Gender-specific trials; 4.5 The Cochrane Library; 4.6 Registration of trials; 4.7 Registries of trials; 4.8 Other state measures; Chapter 5 The activities of clinical trials; 5.1 Stages of activities; 5.2 Division of responsibilities; 5.3 Impediments to performance of activities; 5.4 Aids to ensuring orderly transition of activities. Chapter 6 Coordinating and other resource centers in multicenter trials6.1 Introduction; 6.2 Coordinating centers; 6.3 Study chair and office of the study chair; 6.4 Central laboratories; 6.5 Reading centers; 6.6 Project offices; 6.7 Support centers; Chapter 7 Multi-study networks; 7.1 Introduction; 7.2 Examples of networks; 7.3 Advantages and disadvantages; 7.4 Modes of creation and funding; 7.5 Organizational structures; 7.6 Operating structures; Chapter 8 Ethical principles and imperatives in clinical trials; 8.1 Introduction; 8.2 Medical research codes. 8.3 Principles of medical ethics in research8.4 The state of clinical equipoise; 8.5 The ethics of choice of study treatments; 8.6 The monitoring imperative; 8.7 The ethics of disclosures for consents and of confl icts of interest; Chapter 9 Objectivity versus competency in clinical trials; 9.1 Introduction; 9.2 Objectivity constructs and rules; 9.3 Ethical limits of imposed objectivity constructs; PART 2. DESIGN PRINCIPLES AND PRACTICES; Chapter 10 Fundamentals of controlled clinical trials; 10.1 Introduction; 10.2 Choice of the test and control treatments. 10.3 Principles in the selection of the outcome measure10.4 Principles of establishing comparable treatment groups; 10.5 Principles of masking and bias control; Chapter 11 Bias; 11.1 Introduction; 11.2 Absolute versus relative truth and bias; 11.3 Selection and representation biases; 11.4 Treatment-related biases; 11.5 Indicators of bias; 11.6 Bias "fix," avoidance, and prevention strategies; Chapter 12 Bias control; 12.1 Introduction; 12.2 Randomization; 12.3 Concealment; 12.4 Masking philosophy of the trialist; 12.5 Specificity, training, and surveillance.
520			_a"First published in 1986, this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical trials. It contains a wealth of practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail on such issues as sample size calculation, stratification and randomization, data systems design, development of consent forms, publication policies, preparation of funding requests, and reporting procedures. While the basics of design, conduct, and analysis of clinical trials remain the same, there have been significant changes since the first edition of Clinical Trials was published two decades ago. In this new edition, the author discusses the refinements and improvements made to methods and procedures, changes in the policies and guidelines underlying trials, as well as requirements for registration of trials. He also discusses current practices for data sharing, for gender representation, for treatment effects monitoring, and for ethical standards of clinical trials. The importance of the randomized controlled trial has grown significantly over time and they are now the cornerstone of all evidence-based medicine. Still rich in tables, checklists, charts, and other resources for the trialist, the second edition of Clinical Trials is an indispensable reference for clinicians, biostaticians, epidemiologists, and anyone involved in the design and implementation of a clinical trial"--Provided by publisher.
650		0	_aClinical trials.
650	1	2	_aClinical Trials as Topic
830		0	_aMonographs in epidemiology and biostatistics ; _vv. 39.
942			_cBK _2ddc