ARCS is Australia’s primary professional development association for people working in the development of therapeutic goods. At the annual scientific congress held in Sydney recently, Dr Maria Ali, Head of Medical and Safety Services of George Clinical, was invited to speak on the topic on Risk Based Monitoring (RBM).
Dr. Ali manages George Clinicals’ medical monitoring, safety and endpoints teams; and works closely with the scientific team from The George Institute to develop and implement scientific leadership models for George Clinical studies. She also develops new ideas for clinical research, and processes to improve clinical trial design and efficiencies.
At ARCS, Dr Ali and other industry leaders presented and discussed changes in monitoring practices, source document verification (SDV) and technology. As regulators and industry step up their encouragement on RBM practices, it was one of the most attended sessions in the conference. Dr Ali’s presentation focussed on setting the stage for the current situation with RBM, discussing the environment, perceived benefits, components and enablers that are driving the shift to RBM. She closed with George Clinical’s experience on RBM as scientifically led CRO, and on the challenges ahead. Her presentation can be downloaded here.
ARCS Presentation Direct Download
Overview:
Part I: Setting the stage
- Where – Environment
- Why – Perceived benefits
- What – Components
- How – Enablers
Part II: CRO / ARO perspective
- Experiences
- Challenges
PART I: Answering Questions: Where? Why? What? How?
Where? Clinical trial environment
- Number and complexity of molecules discovered / discover methods
- Number of trials
- Complexity of trial design
- Complexity of patient populations, more sites with less patients, wider geographic locations
- Completion time and cost of trials
Where? Regulatory Environment
Where? Initiatives
Clinical Trials Transformation Initiative
- Public-private partnership
- Over 60 organisations
- Quality by Design
Transcelerate Biopharma
- Collaboration of global biopharmaceutical companies
- Risk Based Monitoring (one of 5 initial goals)
Why RBM?
- Enhanced subject protection
- Improved data quality
- Reduced trial costs
What is RBM?
Risk Assessment and Planning
- On-site Monitoring
- Remote Monitoring
- Centralised Monitoring
How?
PART II
RBM experience at George Clinical
- Risk based monitoring of commercial studies
- Risk based monitoring of academic studies
Considerations and Challenges
Business Context
- CRO size
- Market
- Geography
- Resource Investment
People
- Training
- Change Management
- Breaking silos
Processes
- Protocol Development Access and involvement in process
- Re-engineering traditional team structures
- Communication Sponsor – CRO – Site
Technology
- Enabling technologies
- Source of data
- Choice of critical risk indicators few vs. many
- Vendor / solution selection
