ClinicalTrials: Design, Conduct and Analysis

ClinicalTrials: Design, Conduct and Analysis

by Curtis L. Meinert

Hardcover(New Edition)

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ClinicalTrials: Design, Conduct and Analysis by Curtis L. Meinert

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.

Product Details

ISBN-13: 9780195387889
Publisher: Oxford University Press, USA
Publication date: 03/27/2012
Series: Monographs in Epidemiology and Biostatistics Series
Edition description: New Edition
Pages: 720
Product dimensions: 7.10(w) x 10.10(h) x 1.70(d)

About the Author

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.

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


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