Clinical Trials

Design, Conduct and Analysis
2. Auflage 2012
ISBN: 978-0-19-538788-9
Verlag: OUP US

Buch, Englisch, 944 Seiten, Format (B × H): 183 mm x 260 mm, Gewicht: 1493 g

Reihe: Monographs in Epidemiology and Biostatistics

The most comprehensive coverage of clinical trial design, conduct, and implementation -written by one of the leading authorities in the field.
All content is practically presented, with detailed discussions and clear examples, making the book useful for many different people involved in clinical trials.
The text is a useful teaching guide because it contains a detailed introduction to clinical trials and useful guidance for all stages of a trial.
The text features countless resources for trialists including dozens of checklists, examples of reporting forms and consent forms, etc.

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.

Zielgruppe

Clinical trialists, clinicians, biostaticians, epidemiologists, researchers in all fields, and anyone involved in the design and implentation of clinical trials.

Autoren/Hrsg.

Meinert, Curtis L.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Epidemiologie, Medizinische Statistik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik

Inhaltsverzeichnis

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

Über Autor(innen)

Meinert, Curtis L.
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.

Curtis L. Meinert, PhD, Professor, Epidemiology and Biostatistics, Bloomberg School of Public Health, Johns Hopkins University

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.