A Practical Guide To Human Research And Clinical Trials

Many health professionals are expected to conduct their own trial, or to participate in trials by recruiting subjects. Everyone who is conducting clinical research should have a sufficient understanding of the scientific and administrative aspect, including an awareness of the regulation and guidelines associated with clinical trials.      This textbook addresses many issues of human clinical research and clinical trials, and provides comprehensive overview of the design, conduct and analysis of all the phases of clinical trials. It is aimed at health and other research professionals and students. Salient Features ·         Book can be used as teaching aid and as a reference guide. ·         Important concepts are presented throughout the chapters with diagrams and check lists. 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 26. Clinical Biostatistics, (a) Biostatistics for clinical Researcher, (b) Terminology used in Biostatistics About the Editors: 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. P Usha Rani, Additional Professor of Clinical Pharmacology and Therapeutics at Nizam’s Institute of Medical Sciences, Hyderabad, India, is a well known clinical researcher. Along with Dr Naidu, she has developed and validated various non-invasive models for evaluation of drugs. Due to her immense interest in clinical research especially in field of diabetes and hypertension, she is Principal Investigator in many National and International clinical trials and academic research projects.  In recognition of her outstanding contributions in the field of clinical research, Dr Usha has been awarded the UK Seth Gold Medal and P. P. Suryakumari Prize. She has authored more than 70 research publications, co-authored chapters in books and SOPs for Institutional Ethics Committee.