Description: Clinical research in India has grown at an unprecedented rate in the last few years opening many new opportunities. At the same time, especially being a part of global clinical trials, it has put serious challenges for the compliance of trial conduct and validity and integrity of clinical trial data. Towards contributing to the corporate goals of established and emerging CROs and pharmaceutical firms, regarding research, innovation, profitability, and long-term sustainable growth, clinical research domain has become highly regulated and complicated requiring sound knowledge, project management skills and aspirations to achieve compliance with domestic and international regulations as well as towards achieving competitive, quality, compliance, cost and time benefits.
This book, an a next-generation book, with plenty of tables, figures, and flow charts has been written with a purpose to satisfy the above unmet need and provides a quality pathway for conducting clinical trials.
Contents: List of Abbreviations • Chapter 1: Introduction to Clinical Research • Clinical Trial: Definition • Significance of Clinical Trials • Sponsor and Site for Clinical Trial • Regulations Governing Clinical Trials • Ethics Committee in Clinical Trials • Risks Involved in Clinical Trials • Benefits of Clinical Trials • Participants in Clinical Trials • Conducting a Clinical Trial • After the Completion of a Clinical Trial • Types of Clinical Trials • New Drug Development Process • Clinical Development of a New Drug • Phase I Trials (Human Pharmacology Trials or First in Human Studies) • Types of Phase I: Trials • Single Ascending Dose (SAD) Studies • Multiple Ascending Dose (MAD) Studies • Food Effect • Phase II: Trials (Therapeutic Exploratory Trials or Proof of Concept) • Phase III: Trials (Therapeutic Confirmatory Trials) • Phase IV: Trials (Post-Marketing Trials) • Clinical Trials in India • India – An Ideal Destination for Clinical Trials • Challenges in India • Appendix I: History of Research in Humans: Genesis of Regulations • Appendix II: International Conference on Hormonization • Appendix III: ICH Guidelines • Appendix IV: ICH Efficacy Topics • Chapter 2: ICH-GCP versus Indian GCP • Differences in Glossary of terms/definitions • ICH-GCP versus Indian GCP – A Glimpse • IRB/IEC Composition • Documents for IRB/IEC Submission • Documents to be Obtained from IRB/IEC • Essential Documents for the Conduct of a Clinical Trial • Before the Clinical Phase of the Trial Commences • During the Clinical Conduct of the Trial • After Completion or Termination of the Trial • Chapter 3: Clinical Trial Framework • Flowchart 1: Clinical Project Assessment • Flowchart 2: Clinical Project Planning • Flowchart 3: Prerequisites for the Study • Flowchart 4: Study Design • Flowchart 5: Clinical Trial QA-QC System • Flowchart 6: Management of IP and IP-Related Documents • Flowchart 7: Compensation for Subject’s Participation • Flowchart 8: IRB/IEC Decision-making Process • Flowchart 9: Selection of Contract Research Organization (CRO) • Flowchart 10: Investigator and Site Selection • Flowchart 11: Subject Recruitment Procedure • Flowchart 11A: Therapeutic Trial • Flowchart 11B: Non-Therapeutic Trial • Flowchart 11C: Pregnant or Nursing Women as Research Subject • Flowchart 11D: Children as Research Subject • Flowchart 11E: Vulnerable Subjects as Research Subject • Flowchart 12: Screening and Trial Procedures Initiation • Flowchart 13: Clinical Trial Monitoring • Flowchart 14: Ongoing Safety Evaluation and New Safety Information • Flowchart 15: Safety Reporting • Flowchart 16: Safety Updates Reports and Trial Progress Reports • Flowchart 17: Deviation/Non-Compliance on the Part of Investigator • Flowchart 18: Modifications/Amendments in the Study Protocol • Flowchart 19: Premature Termination or Suspension of Clinical Trial • Flowchart 20: Trial Completion • Chapter 4: Miscellaneous Topics in Conduct of Clinical Trials • Stakeholders in Clinical Trials • Steps in Clinical Trial Conduct • Informed Consent Document • Informed Consent • Nature of the Subject and Nature of the Trial • Re-consent Issues • Deviations, Violations and Non-Compliance • Unidentifiable or Non-Assessable Adverse Events • Must the Investigator be a Physician? • Raw Data or Source Data/Documents • “ALCOA” Principle for Source Data • Protocol • Investigator’s Brochure • Case Report Form (Crf) • Irb/Iec • Reviews by Irb/Iec • Audit • Clinical Trials Registry of India (Ctri) • Common Gcp Issues During the Trial/Study • Inquiry by Regulatory Authorities • Common Findings in a Regulatory Inspection • Investigator-Sponsored Trial (Ist) • Applicable Regulatory Authorities (Ara) • Chapter 5: Quality, Compliance and Management Issues • Establishment of the Quality System • Project Planning • Human Resource Planning and Establishment • Quality Assurance and Quality Control Planning and Establishment • Resources Planning and Establishment • Budgetary Planning • Time Frame Planning • Developing the Time Plan for a Clinical Trial • Critical Path Analysis • Tentative Timelines: Before Study Initiation • Tentative Timelines: During Study Conduct • Tentative Timelines: After Study Completion • Implementation of the Quality System • Control and Evaluation of the Quality System • Budgetary Control • Time Control • Recruitment and Retention Control • Compliance Control • Constant Updating of the Quality System • Summary of GCP • References.
About the Author: Umesh C. Gupta has rich experience in clinical research, has worked in various areas of clinical research including planning, designing, managing, conduct, monitoring and reporting of clinical trials. He has been a teaching faculty for various diploma level courses in clinical trials. he has been a teaching faculty for various diploma level courses in clinical research and has sound knowledge of new drug clinical development and clinical research regulations. Besides holding a lifetime membership of Indian Society of Clinical Research, he has many publications to his credit in various peer-reviewed journals.