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

ClinicalTrials: Design, Conduct and Analysis

byCurtis L. Meinert

Hardcover | March 1, 2012

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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 practicalinformation 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 andprocedures, 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 ofthe 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.
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...
Title:ClinicalTrials: Design, Conduct and AnalysisFormat:HardcoverDimensions:944 pages, 10 × 7 × 0.98 inPublished:March 1, 2012Publisher:OUPLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0195387880

ISBN - 13:9780195387889


Table of Contents

Part 1: Introduction1. Introduction2. The language of clinical trials3. Types and classes of trials4. The state and nature of trials5. The activities of clinical trials6. Coordinating and other resource centers in multicenter trials7. Multi-study networks8. Ethical principles and imperatives in clinical trials9. Objectivity versus competency in clinical trialsPart 2: Design principles and practices10. Fundamentals of controlled clinical trials11. Bias12. Bias control13. Variance control14. The study treatments15. Outcome measures16. Sample size and power estimates17. Randomization18. Treatment masking19. The study plan20. Data collection considerationsPart 3: Execution21. Data collection forms22. Start-up and maintenance procedures23. Participant recruitment and enrollment24. Patient followup, close out, and post trial followup25. Midcourse changes and coping strategies26. Adverse events (AEs)27. Quality assurancePart 4: Data analysis28. Basic data analysis and counting principles for primary results publications29. Study datasets30. Basic data analysis procedures31. Questions concerning the design, analysis, and interpretation of clinical trials32. Treatment effects monitoring33. Issues in treatment effects monitoring34. Subgroup analysesPart 5: Organization and management35. Funding36. Organizational design and structure37. Study governance38. Study organizational structures and meetings39. Regulations, requirements, policies, and guidelinesPart 6: Publication40. The publication imperative41. Presentation, publication, information, and data access policies42. Preparation of study publications43. Document and report production44. Reading reports of trialsPart 7: Miscellaneous45. Scientific integrity46. Transgressions of trialists47. Homogeneity versus heterogeneity in trials48. Meta-analysis49. The University Group Diabetes Program (UGDP)50. Training trialists51. Comparative effectiveness research (CER) and clinical trials52. Readings and reference materialsPart 8: AppendicesA. Glossary of definitionsB. Terminology usage and recommendationsC. Medical research codes of ethicsD. Teaching questions and answersE. Aids for trialistsF. Data items and forms illustrationsG. Randomization illustrationsH. Activities by stage of trialI . Sketches of trials: Year 2006 publications in NEJM, JAMA, Br Med J, and LancetJ. Sample study documentsK. User datasetsL. AbbreviationsReferencesIndex