Overview

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.

Full Product Details

Author:   Curtis L. Meinert (Professor, Epidemiology and Biostatistics, Bloomberg School of Public Health, Professor, Epidemiology and Biostatistics, Bloomberg School of Public Health, Johns Hopkins University)
Publisher:   Oxford University Press Inc
Imprint:   Oxford University Press Inc
Edition:   2nd Revised edition
Dimensions:   Width: 18.60cm , Height: 3.90cm , Length: 25.50cm
Weight:   1.420kg
ISBN:  

9780195387889

ISBN 10:   0195387880
Pages:   720
Publication Date:   19 April 2012
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   To order  
Stock availability from the supplier is unknown. We will order it for you and ship this item to you once it is received by us.

Table of Contents

Part 1: Introduction 1. Introduction 2. The language of clinical trials 3. Types and classes of trials 4. The state and nature of trials 5. The activities of clinical trials 6. Coordinating and other resource centers in multicenter trials 7. Multi-study networks 8. Ethical principles and imperatives in clinical trials 9. Objectivity versus competency in clinical trials Part 2: Design principles and practices 10. Fundamentals of controlled clinical trials 11. Bias 12. Bias control 13. Variance control 14. The study treatments 15. Outcome measures 16. Sample size and power estimates 17. Randomization 18. Treatment masking 19. The study plan 20. Data collection considerations Part 3: Execution 21. Data collection forms 22. Start-up and maintenance procedures 23. Participant recruitment and enrollment 24. Patient followup, close out, and post trial followup 25. Midcourse changes and coping strategies 26. Adverse events (AEs) 27. Quality assurance Part 4: Data analysis 28. Basic data analysis and counting principles for primary results publications 29. Study datasets 30. Basic data analysis procedures 31. Questions concerning the design, analysis, and interpretation of clinical trials 32. Treatment effects monitoring 33. Issues in treatment effects monitoring 34. Subgroup analyses Part 5: Organization and management 35. Funding 36. Organizational design and structure 37. Study governance 38. Study organizational structures and meetings 39. Regulations, requirements, policies, and guidelines Part 6: Publication 40. The publication imperative 41. Presentation, publication, information, and data access policies 42. Preparation of study publications 43. Document and report production 44. Reading reports of trials Part 7: Miscellaneous 45. Scientific integrity 46. Transgressions of trialists 47. Homogeneity versus heterogeneity in trials 48. Meta-analysis 49. The University Group Diabetes Program (UGDP) 50. Training trialists 51. Comparative effectiveness research (CER) and clinical trials 52. Readings and reference materials Part 8: Appendices A. Glossary of definitions B. Terminology usage and recommendations C. Medical research codes of ethics D. Teaching questions and answers E. Aids for trialists F. Data items and forms illustrations G. Randomization illustrations H. Activities by stage of trial I . Sketches of trials: Year 2006 publications in NEJM, JAMA, Br Med J, and Lancet J. Sample study documents K. User datasets L. Abbreviations References Index

Reviews

<br>'The most thorough and informative volume on the subject printed so far. In an extremely systematic way most of the pertinent methodological questions are analysed, and thoughtful guidelines provided....A must for all medium size and larger libraries and for those actively involved in clinical trials.'--Pain<p><br>'Comprehensive as most others on the topic are not, and thorough in most respects, the book also contains a glossary, many useful summary appendices, and much practical advice.'--British Medical Journal<p><br>'A good reference for many practitioners of clinical trials... This book has many tables and figures representing the actual data from previous clinical trials, which helps maintain interest for the clinical investigator... The bibliography is particularly well done and includes not only the extensive documentation for the text, but also classic statistical papers... This book would serve as a good reference for anyone engaged in designing, implementing, or conducting a clinical trial.'--Journal of the American Medical Association<p><br>'Covers with great thoroughness the design, execution, and reporting of multicenter and single-center uncrossed trials that have a clinical event as endpoint....Both the authors and the publisher are to be congratulated on the skill with which this complex book was put together...Will be the standard for instruction in and evaluation of controlled clinical trials for years to come.'--The Lancet<p><br>'Scarcely any aspect of the design, organization and analysis of clinical trials is neglected....However, the presentation of the material allows it to be a book both for beginners and for readers already familiar with clinical trials. I believe it would be better to buy Dr. Meinert's book than to acquire an elementary test on clinical trials with the hope of filling the gaps from the literature.'--Canadian Journal of Public Health<p><br>'[The] checklists and examples provide excellent guidance, and the text would be a

Author Information

Curtis L. Meinert, PhD, is a Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health. He was founder of the Center for Clinical Trials and served as its director through September 2005. He was a founding member of the Society for Clinical Trials and was Editor of Controlled Clinical Trials from its inception in 1980 through 1993.

Tab Content 6

Author Website:  

Customer Reviews

Recent Reviews

No review item found!

Add your own review!

Countries Available

All regions