About the Book:

In "A Practical Guide to Human Research and Clinical Trials," delve into the intricate world of clinical research as health professionals navigate the complexities of conducting trials and recruiting subjects. This comprehensive textbook offers a detailed exploration of the scientific, administrative, and regulatory aspects crucial to the successful execution of clinical trials.

Designed as a valuable resource for both seasoned professionals and aspiring students, this book illuminates key concepts with insightful diagrams and practical checklists, making it an essential teaching aid and a go-to reference guide. From the design and implementation to the analysis of clinical trials, this book equips readers with the knowledge and tools necessary to navigate every phase of the research process.

Contents:

1. Clinical Research – A Clinical Investigator’s Perspective 

2. Medical Device Development, Process and Regulation 

3. Preclinical Drug Development 

4. Phases of Clinical Trials 

5. Phase 0 – Micro dosing Studies 

6. Clinical Research Planning 

7. Clinical Research Design 

8. Clinical Research Protocol 

9. Designing Case Report Forms 

10. Process of Randomization in Clinical Trials 

11. Investigational Medicinal Products 

12. Multi  center Clinical Trials 

13. Good Clinical Research Practice 

14. Role and Responsibilities of Sponsor 

15. Role and Responsibilities of Principal Investigator 

16. Ethical Consideration in Clinical Research – Special Reference to Developing Countries 

17. Informed Consent in Clinical Research 

18. Monitoring in Clinical Trials 

19. Quality Assurance in Clinical Research 

20. Pharmacovigilance and Drug Safety 

21. Data and Safety Monitoring Board and Monitoring Plan 

22. Standard Operating Procedures 

23. Archiving Clinical Research Documents 

24. Evidence Based Medicine 

25. Clinical Research Data Management 

About the Authors:

M.U.R.Naidu is currently Professor of Clinical Pharmacology and Therapeutics at Nizam’s Institute of Medical Sciences, Hyderabad, India. He was formerly Dean and Head of the Department of Clinical Pharmacology. He has over three decades of experience in clinical research. He has developed several non-invasive models and methods for evaluation of drugs including tests of psychomotor performance, endothelial function and various models for evaluating pain. He has authored more than 150 research publications, contributed chapters in books and also authored SOPs of Institutional Ethics Committee. He is an ardent researcher, renowned teacher and distinguished guide to fellow researchers and postgraduate student of clinical pharmacology and research.