Clinical Research, Principles, Practices, Perspectives

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 Advances1.    Newer Paradigms in Drug DevelopmentSection – B - Drug Regulations: International Scenario2. International Drug RegulationsSection – C - Drug Regulations: Indian Scenario3. Evolution of Drug Regulations in India4. Drug Regulatory Framework in India5. Drug Approval Process in IndiaSection – D - Drug Regulations: Specialized Areas of Clinical Research6. Clinical Research on Biologics7. Clinical Research on Traditional Medicine8. Clinical Research on Medical Devices9. Clinical Research on Stem Cells10. Clinical Research in Special Populations11. Bioavailability and Bioequivalence StudiesSection – E - Clinical Research: Ethical Considerations12. Evolution of Ethics in Research13. Ethical Principles and Issues in Research14. Ethics Committee15. Informed Consent16. Compensation Issues in Clinical TrialsSection – F - Clinical Research: An Overview17. Types and Principles of Clinical ResearchSection – G - Clinical Trials: Methodological Aspects18. Good Clinical Practice19. Practical Considerations in Designing and Conducting Clinical Trials20. Designs used in Clinical Trials21. Randomization22. Blinding23. Bias24. Compliance in Clinical Trials25. Clinical Trial Monitoring26. Data and Safety Monitoring Boards27. Clinical Data Management28. Case Report Form29. Quality Management in Clinical Research30. Biomarkers31. Multicentric Clinical TrialsSection – H - Clinical Drug Development: Premarketing Phases32. Phase Zero Clinical Trials33. Phase 1 Clinical Trials34. Phase 2 and 3 Clinical TrialsSection – I - Clinical Drug Development: Postmarketing Phases35. Phase 4 Research36. Post Marketing Surveillance37. Pharmacovigilance38. Drug Utilization Research39. Pharmacoepidemiology40. PharmacoeconomicsSection – J - Clinical Research: Special Areas41. Oncology Clinical Trials42. Clinical Research on Vaccines43. Orphan Drug Research44. Surgical Clinical TrialsSection – K – Annexures
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.