About the Book:

In an arena which has seen rapid change over the past decade, Principles of Clinical Research provides a straightforward and up-to-date guide to the planning, organization and management of clinical trials.

With a very practical emphasis, all aspects of the scientific and ethical conduct of clinical research are covered, including trial design, protocol writing, case record form design, pharmacokinetics, selection of volunteers and investigators, safety issues, adverse events and monitoring, outcomes research, statistics, data management, archiving, audits, and communications. Focusing also on controversial topics which are of increasing concern in clinical studies, separate chapters are devoted to outsourcing, regulations for biotechnology products, legal and ethical issues, and fraud and malpractice.

Bibliographics and a comprehensive subject index further enhance the book’s accessibility as a reference source.

Contents:

1. The drug Development Process

2. Medicinal Product Regulations in the 21st century

3. Ethical Issues

4. Liability and indemnity in clinical Research

5. Clinical trial design

6. Early phase studies, pharmacokinetics and adverse drug interactions

7. Phase IV Studies

8. The clinical trial protocol

9. Case record form design

10. Clinical trial supplies

11. Investigator selection

12. Monitoring

13. Drug safety in clinical studies and pharmacovigilance

14. Outcomes research and health economics

15. Data management, now and in the future

16. Statistical thinking for clinical trials

17. Project management of drug development

18. Communication effectively

19. Audits and inspections

20. Trial master file

21. Archiving

22. Outsourcing clinical research projects

23. New directions: regulations for biotechnology products and medical devices

About the Editors:

Ignazio di Giovanna is Director of CCA2000 Ltd, East Horsley, UK, a Clinical Research Organization.