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About the Book:

·       Comprehensive content covering all aspects of clinical research.

·       Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc.

·       Milestones in the evolution of drug regulations in India

·       Drug regulatory framework in India and key ICH countries.

·       Evolution of drug pricing mechanisms and IPRs in India.

·       Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017.

·       Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019.

·       Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.

Contents:

Section – A - Drug Development: Recent Advances

1.    Newer Paradigms in Drug Development

Section – B - Drug Regulations: International Scenario

2. International Drug Regulations

Section – C - Drug Regulations: Indian Scenario

3. Evolution of Drug Regulations in India

4. Drug Regulatory Framework in India

5. Drug Approval Process in India

Section – D - Drug Regulations: Specialized Areas of Clinical Research

6. Clinical Research on Biologics

7. Clinical Research on Traditional Medicine

8. Clinical Research on Medical Devices

9. Clinical Research on Stem Cells

10. Clinical Research in Special Populations

11. Bioavailability and Bioequivalence Studies

Section – E - Clinical Research: Ethical Considerations

12. Evolution of Ethics in Research

13. Ethical Principles and Issues in Research

14. Ethics Committee

15. Informed Consent

16. Compensation Issues in Clinical Trials

Section – F - Clinical Research: An Overview

17. Types and Principles of Clinical Research

Section – G - Clinical Trials: Methodological Aspects

18. Good Clinical Practice

19. Practical Considerations in Designing and Conducting Clinical Trials

20. Designs used in Clinical Trials

21. Randomization

22. Blinding

23. Bias

24. Compliance in Clinical Trials

25. Clinical Trial Monitoring

26. Data and Safety Monitoring Boards

27. Clinical Data Management

28. Case Report Form

29. Quality Management in Clinical Research

30. Biomarkers

31. Multicentric Clinical Trials

Section – H - Clinical Drug Development: Premarketing Phases

32. Phase Zero Clinical Trials

33. Phase 1 Clinical Trials

34. Phase 2 and 3 Clinical Trials

Section – I - Clinical Drug Development: Postmarketing Phases

35. Phase 4 Research

36. Post Marketing Surveillance

37. Pharmacovigilance

38. Drug Utilization Research

39. Pharmacoepidemiology

40. Pharmacoeconomics

Section – J - Clinical Research: Special Areas

41. Oncology Clinical Trials

42. Clinical Research on Vaccines

43. Orphan Drug Research

44. Surgical Clinical Trials

About the Authors:

Dr. Niti Mittal (MD, DM) pursued her post-graduation in Pharmacology and DM (Clinical Pharmacology) from the prestigious institute, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh. She graduated from Government Medical College and Hospital, Chandigarh. She is currently working as an Assistant Professor in the Department of Pharmacology, Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana. During her academic career, she has been actively involved in various research, academic, and pharmacovigilance activities. She holds a sound working knowledge in the field of clinical research and has conducted varied types of research including randomized controlled trials, observational studies, Phase 1 study, meta-analysis etc. She has to her credit more than 40 national and international publications in indexed medical journals. She has contributed chapters in Indian books on clinical research, pharmacology and antibiotics. Her research paper was nominated for U.K. Seth award presentation at a conference organized by Indian Pharmacological Society. She is life member of renowned societies like Indian Pharmacological Society (IPS), Association of Physiologists and Pharmacologists of India (APPI), Indian Society of Rational Pharmacotherapeutics (ISRPT), Society of Pharmacovigilance of India (SOPI)and Indian Society of Clinical Research (ISCR). She is among the peer review panel of various national and international indexed journals.

Dr. Bikash Medhi is a Professor & Ex-Additional Medical Superintendent (AMS) in PGIMER, Department of Pharmacology. His area of expertise is Experimental Pharmacology, Clinical Research, Regulatory Pharmacology, Development of nanoformulations, Pharmacogenetics, Pharmacogenomics and Stem cells etc. He has more than 20 years of teaching and research experience and has owned more than 65 prestigious National and International Awards, namely, Dr. D N Prasad memorial award with Gold medal 2009 from Indian Council of Medical Research (ICMR), New Delhi, V K Bhargava Award with a Gold medal from National Academy of Medical Sciences 2013, Col. R N Chopra Oration 2014 by Indian Pharmacology Society (IPS), NN Dutta Award 2016 by Indian Pharmacology Society (IPS), Dr. B N. Ghosh Oration at 43rd Annual Conference of IPS and International Conference on “Pharmacology & Translational Research” He is in core panel of expert for Task Force in IND application & Regulatory Affair, lead GLP Inspector, lead GCP inspector, Principle Assessor for NABH, He is in several committees in DCGI office, ICMR, DBT, DST, CSIR, NBE, MCI etc.

He has authored five books and 150 chapters and published more than 400 articles in National & International journals. Further, he was selected as a member of various central government committees (GOI) and central government funding agencies: in the IND committee, FDC Committee, Compensation Committee, Sub-committee of Drug Regulation, Amendment Committee, Central Working Group Committee for Pharmacovigilance (PvPI), Signal Preview Committee, Member of Biologic Task Force DGCI-DBT committee, Member of GCP inspection team DCGI, Core Training Panel Committee Pharmacovigilance (PvPI), National Formulary Committee (NFI)–IPC, Chairman selection Committee for TA (IPC), Special Invitee for national Advisory board of Hemovigilance programme, Special Invitee for Central Ethics Committee ICMR, member of the committee for evaluation of Spurious Drugs, antimicrobial evaluation committee (ICMR). Basic Medical Sciences Project evaluation Committee (ICMR), HCG Vaccine Committee (ICMR), Member of Apex Technical committee for ICMR institute, Core member for Committee ICMR-NIREH Bhopal, member of ICMR funding to CDRI, Special Invitee - TB Task Force, DBT Task Force member, the Expert member for antidoping (NADA) and member of Expert group NADA, National Board Examination (NBE), Senate and selection committee member for NIPER, Member of Board of studies of Panjab University, Chandigarh, Working as GLP inspector for GLP monitoring authority (DST, New Delhi), member of Technical committee Department of Health Research (DHR), Ministry of health etc. He has been working in the national task force for COVID-19 and central ethics committee ICMR and working groups for COVID-19.

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