Regulatory Science Symposium: “Keys to a Clinical Trial: Management and Operations” Session 2 - Introduction to Clinical Trial Management and Operations (2024)

Competencies: Pharmacy, Regulatory Science, Regulations, Clinical Trials, Regulatory and Quality Sciences, Policies and Procedures, Clinical Trial Workforce

Course Syllabus/Topics:

1. Introduction and Agenda
1. Clinical Trial (CT) Process
2. Role of the Clinical Trial Manager
3. Challenges of CT Process
2. Definitions
1. What is Clinical Trial Management (CTM)?
1. Definitions
1. Clinical Trials (CT): Research studies conducted to evaluate the safety and efficacy of new drugs, medical devices, treatments, or interventions in humans.
2. Clinical Trial Management: The process of planning, organizing, coordinating, and overseeing the various aspects of a clinical trial, from its inception to its completion.
3. Effective management is crucial to ensure they are conducted ethically, efficiently, and in compliance with regulatory requirements.
1. Project management and regulatory compliance are required throughout this process 
2. Role of CTM
1. Key responsibilities in UK Trial Managers’ Network include:
1. Lead role in planning, coordinating and completing a project; Communication and presentation skills; organizing and motivating others; managing trial budget(s) and maintaining accounts; Having strategic, tactical and operational management skills; Having flair, enthusiasm, innovation and leadership when faced with challenges (Farrell et al. Trials 2010)
3. CT Process:
1. Project Management and Regulatory Compliance are required throughout.
4. Protocol Development
1. A detailed protocol outlines trial objectives, design, methodology, and participant eligibility criteria
2. Key activities:
1. Authoring the protocol as clearly as possible
2. Training the sites on all aspects of the protocol
3. Best Practices in Clinical Research Protocols from an IRB member/RA Endorsed
1. List of best practices in clinical research protocol writing (endorsed by a regulatory expert)
2. Protocols are becoming more complex
3. Include relevant information for who has to use the protocols
4. Referring to study “participants” rather than subjects
5. Consider how to position protocol depending on the kind of study it is
4. FDA Biomonitoring Research Program (BIMO)
1. Protocol adherence and compliance are two things people find during site inspections
2. BIMO releases metrics for types of inspections done
3. For Federal Year (FY) 2022 Common Clinical Investigator Inspectional Observations
1. Lists frequent protocol adherence or compliance issues
2. Available at: BIMO Inspection Metrics | FDA
5. Site Selection/Management:
1. Keys to Site Selection:
1. Access to a relatively high volume of patients who meet eligibility criteria
2. Expertise in therapeutic area
3. Appropriate facilities/equipment
4. Trained investigators and staff eager to perform research
5. Familiarity with trial procedures (contracting, ICFs, regulatory submissions, etc.)
6. Previous research experience of study site can indicate past performance and recruitment and data quality
2. Keys to managing CT sites: communication and relationships.
6. Qualifying Investigators and Sites
1. Success of a study comes back to the study team.
7. Patient Recruitment and Enrollment
1. Patient recruitment is widely recognized as a key determinant of success for clinical trials
2. When recruitment goals are not met, there are significant scientific, financial, ethical and policy implications.
3. Effects on stakeholders who directly contribute
1. Developing strategies for recruiting eligible participants and managing enrollment processes is a critical CTM activity.
8. Data Collection and Monitoring
1. Establishing procedures for collecting, recording, and managing CT data before and during a study are needed to ensure data integrity and quality.
9. Adverse Event Reporting
1. Sponsors and sites need systems for documenting adverse events promptly, per federal code of regulations.
2. Quality Management Systems consist of both process and procedural documentation
1. Clear and concise
2. Fit for purpose
3. Decision trees ensure there is a system in place for collecting adverse event information.
10. Budgeting and Resource Management
1. Developing and managing budgets (allocating resource efficiently) is one of the biggest challenges in CTM!
1. Not just about determining costs, but determining how to support these costs
2. Budget Development involves three components:
1. Identifying cost of all research items and services required for the study
2. Assigning financial responsibility for all items and services
3. Maintaining a process for recovering costs throughout the study
3. Financial management plan is needed, including a defined department process and responsibility log which outlines team members accountable for the process
4. Clinical resource management
1. Definition: Capability to manage resources of a CT such as investigative site, contract research organizations, clinical study staff, supplies, relationships and participants.
2. Use tools that stimulate protocol implications, estimate resource consumption, respond to change, and implement tools to manage resource utilization and effectiveness.
1. Clinical Trial Management Systems (CTMS) can be useful.
11. Quality Assurance and Auditing
1. Ensuring compliance with good clinical practice (GCP) guidelines and conducting audits
1. Refer to International Council for Harmonisation of Technical Requirements For Pharmaceuticals For Human Use (ICH) E6(R3-draft): Quality Assurance and Quality Control
2. More on CT quality assurance in Clinical Trial Quality Module #2 (Auditing). Enroll for free: http://uscregsci.remote-learner.net.
12. Trial Closeout
1. Managing the close out process includes query resolution, data lock/analysis, report authoring, publication planning, and returning results to participants in plain language.
13. Clinical Study Report Authoring
14. Plain Language Summaries (PLS)
1. Easy to understand, stand alone factual summaries of clinical trial results
1. Understandable by participants and by lay people
2. Have the potential to improve public understanding of and engagement with pharmaceutical research
3. In Europe, there is regulation that requires plain language summaries in public domain
1. No such regulation in the United States, it is voluntary.
2. PLS Best Practices
15. Challenges of CT Process: Regulatory compliance and project management
1. Regulatory compliance with US regulations means adhering to Good Clinical Practice (GCP)
16. Other Reported Challenges of Managing Clinical Trials
1. Technological Integration
2. Ethical Considerations
3. Globalization And Cultural Differences
4. Emerging Technologies and Therapies
5. Patient-Centricity
17. Q&A
    
    

Acknowledgements
Accompanying text created by:
Roxy Terteryan, RKS Project Administrator, SC CTSI (atertery@usc.edu)
Nikhita Datar, Student Worker