PRINCIPLES AND PRACTICE IN CLINICAL RESEARCH

Principles and Practiceof Clinical Research, FourthEdition has been thoroughlyrevised to provide a comprehensive look at boththe fundamental principles and expandingpractice of clinical research.New to thisedition of this highly regarded reference, authors have focusedon examples that broadly reflect clinical research on a global scale while including a discussion of international regulations,studies, and implications.

In addition tokey topics such as bioethics, clinical outcome data, cultural diversity,protocol guidelines, and omic platforms, this edition contains new chapters devotedto electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both noviceand advanced clinical investigators, this book isa highly relevant and essential resource for all thoseinvolved in conducting research.

Key Features

Features inputfrom experts in the field dedicated to translating scientific research from bench tobedside and back

Provides expandedcoverage of global clinical research

Contains hands-on,practical suggestions, illustrations, and examples throughout

Includes newchapters on the international regulationof drugs and biologics, theemergence of the importantrole of comparative effectivenessresearch and how to identify clinical risks and manage patient safety in a clinical research setting

INDICE:

1. AHistorical Perspective onClinical Research 

Part I - Ethical,Regulatory and Legal Issues
2. Ethical Principles inClinical Research
3. Integrity in Research:  Principles for the Conduct of Research
4. Institutional Review Boards
5. The Regulation of Drugsand Biological Products bythe Food and Drug Administration 
6. International Regulation of Drugsand Biological Products 
7. Data Management in Clinical Trials
8. Data and Safety Monitoring
9. Unanticipated Risk inClinical Research
10. Legal Issues
11. Inclusion of Women and Minorities as Subjects inClinical Research
12. Accreditation of Human ResearchProtection Programs
13. The Role and Importance of Clinical Trials Registries
14. The Clinical Researcher and the Media
15. Clinical Research: A PatientPerspective

Part II - Biostatisticsand Epidemiology
16. Design of ObservationalStudies 
17. Design of InterventionalStudies and Trials 
18. Issues in Randomization
19. Hypothesis Testing 
20. Power and Sample Size Calculations
21. An Introduction to Survival Analysis
22. Intermediate Topics in Biostatistics
23. Measures of Functionand Health-Related Quality of Life
24. Large Clinical Trialsand Registries:  ClinicalResearch Institutes
25. Meta-analysis of Clinical Trials
26. Using Large Datasets for Population-based Health Research
27. Development and Conductof Studies

Part III - TechnologyTransfer, Protocol Development, and Sources of Funding Support for Research
28. Overview of Technology Development and Technology Transfer
29. Writing a Protocol
30. Evaluating a Protocol Budget
31. Clinical Research Data: Characteristics,Representation, Storage andRetrieval
32. Management of Patient Samples and Specimens
33. Getting the Funding You Need toSupport Your Research: Navigating the National Institutes of Health Peer Review Process
34. Clinical Research fromthe Industry Perspective
35. Philanthropy's Role in AdvancingBiomedical Research

Part IV - Clinical Research Infrastructure
36. Managing Clinical Riskand Measuring ParticipantsPerceptions of the Clinical ResearchProcess
37. Clinical Pharmacology and itsRole in Pharmaceutical Development 
38. Career Paths inClinical Research
39. Clinical Research Nursing:  A New Domainof Practice
40. Issues and Challenges for Clinical Research inInternational Settings 
41. The Role of Comparative EffectivenessResearch
42. The Importance and Use of ElectronicHealth Records in Clinical Research
43. Informational Resourcesfor the Clinical Researcher