Risk Based Monitoring- Opportunity or Obstacles
“Analyst have been manually examined thousands of data points in clinical research but with the vast and ever increasing amount of data available, the human brain is unable to do it all.”
Data are coming from operational and laboratory which requires technology to bring these together into something meaningful and actionable. What are these technology which enables to work more efficiently on actual performance?
Applicable steps for Risk Based Monitoring
Let’s break the process into steps,
- Determine risk at both protocol and site level
- Define performance brink
- Determine key risk indicators
- Determine action and response plans
- Define communication plans
- Ensure continuous review and reassessment
- Adjust the plan when necessary
- Provide midterm performance indicators showing how site compare, enabling action or escalation of action as needed
- Trend long term site performance, showing what to monitor, and how much to monitor, whether performed on site or remotely
Risk based monitoring has gained considerable scrutiny in recent years hesitation still remains around the approach. In some cases, risk based strategy could replace the need for such frequent site visits to quarterly or even once a year instead of industry standard of every four to six weeks. A risk based approach with good judgment and sound reasoning can greatly curtail the need for CRAs to be road warriors.
What are the things that any mid-size CRO can appliance for RBM?
- Develop monitoring plan appropriate for the trial
- Conduct early dispute with team members to clearly define
- How to assess risks
- Outline statistical analysis
- Identify what monitors review
- Develop robust risk management plan at the beginning of the study
- Potential risks and strategies to mitigate them should be reviewed regularly with sponsor/CRO partners throughout the life of trial to optimize efficiency decision making and in taking action when risks become reality.
- Establish solid communication pathways for issue discussion and escalation with key team members.
- Pull together different values and presptives from various team members and start with the end in mind.
- Be actively involved in identifying triggers, trending and modeling and programming for data as it is ongoing.
- Frequent ongoing communication with PM, DM CRAs and Biostatician.
- Focus less on source verification and more on source data review and analysis.
- Support clinical sites in developing their own internal quality management plans.
Obstacles for slower adoption
- Commercial Interest
- People concerns
- Technology hurdles
Wait for others to move which is first common strategy, effort to reduce risk as you can learn from others mistakes. And most of the CROs are dependent on monitoring visits to generate their revenue, and scared that they will have to face long term losses until it’s established. Let me tell you in very simple language why anyone wants to change wheels while it is already moving?
This is something related to industry people, as they are well experienced and have to face process change. Everyone has to be part of change, writing metrics too and most importantly “Expertise” tag. “Expertise” tag is going to change in “learning new model”.
Powerful challenge among all, development of whole new system needs strong IT team which is lacking in every Indian CRO or hire third party developer to establish data integrated system. Clinical trial data are to be regularly reviewed for outliers, errors, or other non-compliances, and large volumes of data need to be processed, and it would be require the use of validated and well-designed computerized to minimize the workload.
Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Risk Based Monitoring is one solution to combat the continually rising costs of conducting effective clinical trials. Shifting the costs away from onsite visits and 100 0ercent source data verification toward centralized data collection and monitoring, limited sources and budgets can be better utilized to ensure data quality.
Implementing technology will be critical in strategies to increase efficiency and deliver accurate analyses of clinical study site performance and data quality. However the challenges of moving toward an alternative monitoring approach have slowed industry-wide implementation, the future looks bright for Risk Based Monitoring. The word “risk” is going to reduce risk with “Risk Based Monitoring”.