Clinical Trial Project Management

1st Edition - November 14, 2023
Author: Ashok Kumar Peepliwal
Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 1 3 6 2 7 - 6
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 1 3 6 2 8 - 3

Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across… Read more

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Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting clinical trials.

Cover image
Title page
Table of Contents
Copyright
Foreword
Preface
Acknowledgments
Chapter 1. Historical development of clinical research
Abstract
1.1 Development of clinical trials in world
1.2 Nuremberg code, Germany, and ethical concerns
1.3 Thalidomide disaster
1.4 Declaration of Helsinki-1964
1.5 Development of clinical trials in India
References
Chapter 2. Clinical research
Abstract
2.1 Types of research
2.2 Clinical trials
References
Chapter 3. Clinical trial approval in world
Abstract
3.1 Clinical trial approval process
3.2 Regulatory agencies in world
3.3 United States Food and Drugs Administration (requirement)
3.4 Europe and its member states
3.5 Japan
3.6 Brazil (Agência Nacional De Vigilância Sanitária)
3.7 India (Central Drugs Standard Control Organization, CDSCO)
3.8 Australia
3.9 China
3.10 Singapore
3.11 Canada
3.12 Module 1. Administrative and clinical information
3.13 Module 2. Common technical document (manufacturing and chemistry)
3.14 Module 3. Supporting quality information for clinical study perspective
References
Chapter 4. Project management in clinical trials
Abstract
4.1 Project management
4.2 Project management in clinical trials
4.3 Responsibilities of clinical trial project manager
4.4 Clinical trial project management plan
References
Chapter 5. Role of stakeholders
Abstract
5.1 Sponsor
5.2 Institutional ethics committee (IEC)
5.3 Regulatory
5.4 Investigator and team as stakeholder
5.5 Medical laboratory and team
5.6 Contract research organization
5.7 Rights of a patient in a clinical study
References
Chapter 6. Clinical trial budget assessment and preparation
Abstract
6.1 Clinical trial budget
6.2 Pharmaceutical company or sponsor
6.3 Contract research organization
6.4 Steps in preparation of clinical trial budget
References
Chapter 7. Steps to conduct clinical trials
Abstract
7.1 New drugs: dossier submission to regulatory (United States, Europe, India, Australia, etc.)
7.2 Generic drugs: submission of dossier for bioavailability-bioequivalence study
7.3 Clinical study registration in country-specific registry
7.4 Feasibility study and site selection
7.5 Ethics committee approval
7.6 Clinical study site initiation
7.7 Study-specific training
7.8 Monitoring of clinical trials
7.9 Site close-out visit
7.10 Clinical trial database-lock and freezing
References
Chapter 8. Clinical data management
Abstract
8.1 Introduction
8.2 Clinical data management (CDM)
8.3 Roles and responsibilities of clinical data management team
8.4 Clinical data management and applicable tools
8.5 Standard guidance for clinical data management
8.6 Clinical data management (CDM) process
8.7 Process flow in clinical data management
References
Chapter 9. Audits and inspection
Abstract
9.1 Introduction
9.2 Audit
9.3 Routine audit
9.4 For cause audit
9.5 System audit
9.6 Audit procedure
9.7 Close-out by auditor
9.8 Preparation of audit report
References
Chapter 10. Serious adverse event reporting and compensation
Abstract
10.1 Introduction to serious adverse event
10.2 Reporting of safety information on clinical trials in European Union and its member states
10.3 Serious adverse event reporting and compensation procedure in India
10.4 Safety reporting procedure
10.5 Serious adverse event reporting through SUGAM portal
10.6 Capturing data for safe reporting (24 hours, 14 days, and 30 days)
References
Chapter 11. Randomization, bias, and blinding
Abstract
11.1 Introduction
11.2 Bias in clinical trials
11.3 Randomization
11.4 Randomization methods
11.5 Randomization code generation
11.6 Blinding
References
Chapter 12. Basic statistical tools for clinical data analysis
Abstract
12.1 Introduction
12.2 Basic statistical tools for clinical data analysis
12.3 Conclusion
References
Chapter 13. Advanced statistical tools for clinical data analysis
Abstract
13.1 Introduction
13.2 Crossover design and analysis
13.3 Linear regression method
13.4 Analysis of covariance
13.5 Chi-square test
References
Chapter 14. Pharmacovigilance
Abstract
14.1 Introduction
14.2 United States of America (USA)
14.3 European Union and its Member States
14.4 India
References
Chapter 15. Clinical study report
Abstract
15.1 Introduction
15.2 Procedure to develop clinical study report
15.3 Structure and content of clinical study reports
15.4 Discussion and overall conclusions
References
Chapter 16. Bioavailability and bioequivalence study
Abstract
16.1 Introduction
16.2 Requirement of bioavailability/bioequivalence studies
16.3 Objectives of bioavailability/bioequivalence (clinical Phase-I) studies
16.4 When bioequivalence studies are not necessary (biowaivers)
16.5 Study design
16.6 Determination of washout period between two periods/two sequences
16.7 Subject selection
16.8 Fasting or fed conditions
16.9 Blood sampling schedule
16.10 Procedure of bioavailability/bioequivalence study conductance
References
Chapter 17. Risk-based monitoring
Abstract
17.1 Introduction
17.2 Risk identification and assessment
17.3 Risk formulation
17.4 Risk analysis
17.5 Risk evaluation
17.6 Risk treatment
17.7 Risk treatment plan implementation
References
Chapter 18. Decentralized clinical trials
Abstract
18.1 Introduction
18.2 Differences between decentralized clinical trial and digital trials
18.3 Data Integration in decentralized clinicaltrial
18.4 Indicators for adoption of decentralized clinicaltrial
18.5 Management of decentralized clinicaltrials challenges
References
Chapter 19. Electronic clinical outcome assessment and electronic patient-reported outcome
Abstract
19.1 Introduction
19.2 Clinical outcome assessment (COA) in new drug development
19.3 Electronic patient-reported outcomes
19.4 Digital platforms for electronic patient-reported outcome (ePRO) data collection
References
Chapter 20. Update of ICH-GCP (addendum R2 and R3)
Abstract
20.1 Introduction
20.2 ICH E6 (R2)
20.3 Essential documents for the conduct of a clinical trial
20.4 ICH-GCP (R3)
References
Chapter 21. Frequently asked questions
Abstract
Index

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Ashok Kumar Peepliwal