Essentials Of Clinical Research

The fortunes of Clinical Research are on an upswing. Despite the recession of 2008 and the threats of a new recession, clinical research shows no sign of slowing down. And rightly so, after all economic downturn does not signal a reduced need for medicines or new medicines. The importance of clinical research is also being appreciated by experts from different areas and one sees pharmacists, dentists, surgeons and physicians holding conferences on clinical research.

Clinical research is a vast subject, and any attempt to capture the whole in one book would be an ambitious one. We have resisted from this temptation, and concentrated on therapeutic research only. An attempt has been made to give the student a flavour of the subject, without going into minute details. There are books on each topic, to which only a chapter is devoted in this book. These books may be referred to for detailed information; this book serves as a guide to ‘what to know’.

1. Introduction

2. Glossary

3. Drug Development Process

4. Clinical Trials on Drugs

5. Regulatory Strategy

6. Regulatory Control Over Drugs

7. Ethical Aspects of Clinical Research

8. Responsibility of Stakeholders

9. Clinical Trial Documents

10. Endpoints in Clinical Research

11. Site and Investigator Selection

12. Subject Recruitment and Selection

13. Meetings in Clinical Research

14. Data and Safety Monitoring

15. IND and NDA

16. Clinical Data Management

17. Safety Reporting and Pharmacoviligance

18. Quality Assurance in Clinical Research

19. Standard Operating Procedures

20. Clinical Research Outsourcing

21. Statistics in Clinical Research

22. Insurance and Liability

23. Non-compliance, Misconduct and Fraud

24. Intellectual Property Rights

25. Websites for Information

26. Appendices