Clinical trial project management

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 s...

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Bibliographic Details
Main Author:	Peepliwal, Ashok Kumar
Corporate Author:	ScienceDirect (Online service)
Format:	eBook
Language:	English
Published:	London : Academic Press, 2024.
Subjects:	Clinical trials > Management. Project management. Pharmacology. Clinical Trials as Topic > organization & administration Pharmacology Études cliniques > Gestion. Gestion de projet. Pharmacologie. pharmacology. Electronic books.
Online Access:	Connect to the full text of this electronic book

Table of Contents:

Front Cover
Clinical Trial Project Management
Copyright Page
Contents
Foreword
Preface
Acknowledgments
1 Historical development of clinical research
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
2 Clinical research
2.1 Types of research
2.1.1 Diagnostic research
2.1.2 Preventive research
2.1.3 Genetic studies
2.1.4 Treatment research
2.1.5 Screening search
2.1.6 Epidemiological studies
2.1.7 Quality of life research
2.2 Clinical trials
2.2.1 Types of clinical trials
2.2.1.1 Open-label study
2.2.1.2 Blinded (masked) study
2.2.1.3 Cohort study
2.2.1.4 Pilot study
2.2.1.5 Case control study
2.2.1.6 Randomized clinical study
2.2.1.7 Controlled clinical trial
2.2.1.8 Noncontrolled clinical trial
2.2.1.9 Parallel clinical trials
2.2.1.10 Crossover clinical trials
2.2.2 Phases of clinical trials
2.2.2.1 Phase-0 studies
2.2.2.2 Phase-I studies
2.2.2.3 Phase-2 studies
2.2.2.4 Phase-3 studies
2.2.2.5 Phase-4 studies
References
3 Clinical trial approval in world
3.1 Clinical trial approval process
3.2 Regulatory agencies in world
3.2.1 Timelines for regulatory and ethics committee approval of clinical projects in Asian region
3.3 United States Food and Drugs Administration (requirement)
3.3.1 Role of United States Food and Drug Administration in clinical trials
3.3.2 New drugs approval process in United States
3.3.2.1 Food and Drugs Administration review team
3.3.2.1.1 Project manager
3.3.2.1.2 Medical officer
3.3.2.1.3 Statistician
3.3.2.1.4 Pharmacologist/toxicologist
3.3.2.1.5 Clinical pharmacologist/biopharmaceutics.
3.3.2.1.6 Chemist/biologist/microbiologists
3.3.2.2 Review process
3.3.2.2.1 Clinical study approvals for conductance
3.4 Europe and its member states
3.4.1 Clinical Trial Information System
3.4.1.1 Coordination and harmonization of multinational trials
3.4.1.2 New portal and centralized data base
3.4.1.3 Enhanced public transparency
3.4.1.4 Vulnerable subject protection
3.4.1.5 Amended timelines for application
3.4.1.6 Safety reporting
3.4.2 Transition period
3.4.2.1 Part-I. Scientific and medical product documentation
3.4.2.2 Part-II. National and patient level documentation
3.4.3 Process and timelines
3.4.4 Validation
3.4.5 Assessment
3.4.6 Application outcome
3.4.7 Addition of new member state
3.4.8 Postapplication authorization modification
3.5 Japan
3.5.1 Pharmaceuticals and Medical Devices Agency approval process of clinical trials
3.5.2 Human Ethics Committee role in Japan jurisdiction
3.5.3 Clinical trial notifications
3.5.4 Timelines for clinical trial notification
3.5.5 Role of caretaker in Japan
3.5.6 Challenges of clinical trials in Japan
3.6 Brazil (Agência Nacional De Vigilância Sanitária)
3.6.1 Ethics committee approval in Brazil
3.6.2 Comissão Nacional de Ética em Pesquisa composition: a central ethics committee
3.6.3 Comitê de Ética em Pesquisa composition: a local ethics committee
3.6.4 Registration of clinical trials
3.6.5 Process of clinical trial approval
3.7 India (Central Drugs Standard Control Organization, CDSCO)
3.7.1 New Drugs Clinical Trial Rules-2019
3.7.1.1 Presubmission meeting provisions
3.7.1.2 Postsubmission meeting provisions
3.7.1.3 Validity of clinical trial protocol approval
3.7.1.4 Provisions for bioavailability and bioequivalence studies
3.7.1.5 Provisions for IV (postmarketing trials).
3.7.1.5.1 Provisions on timelines
3.7.1.6 Provisions for ethics committee
3.7.1.7 Provision of application rejection and appeal
3.7.2 The Central Drugs Standard Control Organization
3.7.2.1 Official address of Central Drugs Standard Control Organization
3.7.2.2 Zonal offices of Central Drugs Standard Control Organisation
3.7.2.3 Role of Central Drugs Standard Control Organization in clinical trials in India
3.7.2.4 Regulatory requirement for clinical trial conductance in India
3.7.3 Approval aspects of regulatory
3.7.3.1 Ethics committee approval
3.7.3.2 Clinical trial registration with Clinical Trial Registry
India
3.7.4 Indian Medical Council of Research guidance for biomedical research
3.7.5 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Pra...
3.7.6 Indian Good Clinical Practices
3.7.7 Difference between ICH-GCP and Indian GCP
3.7.8 Amendments in Provisions of Drugs and Cosmetic Act 1940
3.7.9 Clinical study application and fee structure
3.7.10 Instructions for payment of clinical trial application fee
3.8 Australia
3.8.1 Human Research Ethics Committee
3.8.2 Site (identification, assessment, and selection) feasibility
3.8.3 Regulatory process pathway
3.9 China
3.9.1 Registration of clinical trial
3.9.2 Clinical trial approval process
3.9.3 Clinical trial application fee
3.9.4 Ethics committee
3.10 Singapore
3.10.1 Review period
3.10.2 Dossier submission
3.10.3 Ethics committee
3.11 Canada
3.11.1 Registration of clinical trials
3.11.2 Clinical trial approval process
3.11.2.1 Preclinical trial application meeting
3.11.2.2 Clinical trial application
3.11.2.2.1 For pharmaceutical drugs
3.11.2.2.2 For biologicals and radiopharmaceuticals.
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
3.14.1 Ethics committee
References
4 Project management in clinical trials
4.1 Project management
4.2 Project management in clinical trials
4.2.1 Project planning
4.2.1.1 Gantt chart
4.2.1.2 Program evaluation and review technique (PERT) analysis
4.2.1.2.1 Probability of clinical project completion
4.2.1.2.2 Determine the expected duration and variance of each activity of clinical study?
4.2.1.2.3 Find out the critical path and expected clinical trial project completion time?
4.2.1.2.4 What is the probability of clinical project to be completed before 27 months?
4.2.1.3 Critical path method (CPM)
4.2.1.3.1 Construction of critical path method network
4.2.1.3.2 Determine the critical path and project completion time
4.2.1.3.3 Compute total floats and free floats for noncritical activities
4.2.1.4 Earned value management (EVM)
4.2.2 Site selection
4.2.3 Site initiation and execution
4.2.4 Monitoring and controlling
4.2.5 Site closeout
4.3 Responsibilities of clinical trial project manager
4.3.1 Selection of authentic vendor
4.3.2 Time management and budget optimization
4.3.3 Protocol submission to institutional ethics committee
4.3.4 Clinical trial report development
4.3.5 Planning of meetings with stakeholders
4.4 Clinical trial project management plan
4.4.1 Project management team
4.4.2 Clinical study goals/objectives and design
4.4.3 Communication plan
4.4.4 Handling of investigational product (IP)
4.4.5 Serious adverse event handling
4.4.6 Study-monitoring plan (study initiation, monitoring, closeout, and audit activities)
References.
5 Role of stakeholders
5.1 Sponsor
5.2 Institutional ethics committee (IEC)
5.2.1 Ethics committee quorum
5.2.2 Functions of ethics committee
5.2.3 Review process of ethics committee (EC)
5.2.4 Record keeping and archiving
5.3 Regulatory
5.4 Investigator and team as stakeholder
5.5 Medical laboratory and team
5.6 Contract research organization
5.6.1 Clinical trial outsourcing
5.6.2 Process of contract research organization selection
5.6.3 Finance in CRO selection
5.7 Rights of a patient in a clinical study
5.7.1 Patient as a stakeholder
5.7.2 Duties of a clinical trial participant
References
6 Clinical trial budget assessment and preparation
6.1 Clinical trial budget
6.2 Pharmaceutical company or sponsor
6.3 Contract research organization
6.3.1 Study site management
6.3.2 Clinical project management
6.3.3 Clinical data management and electronic data capture
6.3.4 Laboratory
6.3.5 Medical writing
6.3.6 Logistics
6.3.7 Quality assurance audits and control
6.4 Steps in preparation of clinical trial budget
6.4.1 Preparatory phase of clinical trial budget
6.4.1.1 Prior to initiation
6.4.1.2 Personnel cost
6.4.1.3 Hidden costs services/items not listed in the protocol
6.4.2 Budget development
6.4.2.1 Start-up cost
6.4.2.2 Per-subject costs (one single, completed subject)
6.4.2.3 Pass-through cost
6.4.2.4 Additional cost
6.4.2.5 Indirect cost
6.4.3 Budget negotiation and clinical trial agreement
6.4.3.1 Preparedness
6.4.3.2 Leverage
6.4.3.2.1 Positive leverage
6.4.3.2.2 Negative leverage
6.4.3.3 Budget offering or budget proposal
6.4.3.4 Presentation of budget proposal
6.4.3.4.1 Raise your concerns and let answer to come
6.4.3.4.2 Document the negotiation
6.4.3.4.3 Brand value protection.