Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way.
In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today’s regulatory landscape.
Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management in clinical trials.
Together, they explore how the industry has evolved from traditional monitoring approaches to a more holistic model centered on risk-based quality management and quality by design.
Dr. Andrianov shares practical insights on common misconceptions, why simply reducing monitoring is not a strategy, and how technology and analytics can be used to proactively manage risk.
The conversation also examines the changing role of CRAs, and the growing expectations from regulators and inspectors.
Selected Links from the Episode:
Connect with Artem Andrianov
Company: Cyntegrity
Risk Based Quality Management (RBQM)
7 Reasons You’re Not Ready for Risk Based Monitoring (2017) – Kunal Sampat
ICH E8 (General Considerations for Clinical Trials)
FDA Risk-Based Monitoring Guidance
Drug Information Association (DIA)
Society for Clinical Data Management (SCDM)
Centralized Monitoring – SOCRA Blogpost
Source Data Verification (SDV)
Books:
Risk-Based Quality Management Guide for Clinical Research – Artem Andrianov, Johann Proeve (Amazon)
Thinking Fast, Thinking Slow – Kahneman and Tversky (Amazon, Barnes & Noble)
Fundamental of Clinical Trials – Lawrence Friedman (Amazon, Barnes & Noble)
Show Notes
[0:00] Podcast Introduction
- Opening theme and mission of the Clinical Trial Podcast
- Focus on developing effective clinical research leaders
[0:20] Episode Overview & Guest Introduction
- Introduction to Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM)
- Why RBQM remains poorly understood despite over a decade of regulatory discussion
- Introduction of Dr. Artem Andrianov and his background in data quality, biostatistics, and risk management
- Past interaction regarding Kunal’s 2017 article on Clinical Leader
[3:24] Artem Andrianov’s Background & Foundations of Risk Management
- Artem’s experience in clinical data quality and analytics
- Risk management as a universal, everyday concept
- Parallels between natural risk assessment and clinical trials
- Why clinical trials are more complex due to multiple stakeholders and distributed processes
- Full quality management approach is even broader in scope than exclusively risk-based monitoring
[7:38] Evolution of Risk-Based Monitoring
- Early FDA guidance on targeted and triggered monitoring
- Transition from RBM to broader Risk-Based Quality Management
- Expansion of RBQM beyond monitoring to include project management, medical monitoring, and data management
- Difficult to create a formalized consensus standard around what is “risk” for project managers
10:26] ICH E6(R3) and Quality by Design
- Key differences between ICH E6(R2) and E6(R3)
- Alignment with ICH E8: General Considerations for Clinical Trials
- Shift from “critical data” to holistic quality planning
- Introduction of Quality by Design principles at the protocol development stage
[13:07] Practical RBM Implementation Example
- Kunal shares a real-world post-approval study example
- Identifying critical data points aligned with study objectives
- Kunal’s example of reducing CRF fields from 100 to 20 critical variables
- Applying 100% monitoring to critical data only
- Artem’s feedback on adaptive and scalable monitoring strategies
- Create an informed profile of what monitoring is valuable and adjust after some of the 100% monitoring effort is complete
[18:26] Risk Based Monitoring Solutions Available Today
- Four Different Solutions:
- EDC companies that have built dashboards which help their clients to understand clinical trial risk and ongoing activities within a study
- CROs who leverage their own solutions and develop profiles which support their behavior (specifically operational aspects of the study)
- Classic Business Intelligence Solutions (PowerBI, SpotFire, Excel Tables). Good starting point, typically made by the sponsor, but not sophisticated encompassing enough to cover all risk
- Dedicated Solutions (Like Cyntegrity) Designed specifically for clinical trials. Try to understand connected elements within the study to better highlight risk
[27:01] How do Dedicated Risk Based Monitoring Solutions Manage Integration?
- Solved for many types of integrations due to large data warehouses and APIs with open integrations
- Challenge in integration comes from identifying what data points matter for assessing risk when so much information is available.
[29:13] Advantages and Misconceptions about Risk Based Monitoring
- Advantages:
- Increased compliance
- Cost savings on various items (reduced SDV/Visits and reducing risk escalations/diasters)
- Makes study more predictable and successful
- Patient centricity
- Disadvantages:
- Big effort spent understanding specific concepts of risk and of the study design
- Organizations sometimes need to undergo internal changes
- Mindset change creates friction
[35:40] When is it best to engage with a risk based monitoring partner?
- Developing a plan does not occur at a specific point in time it’s more like a journey to work through together with a partner
- AI tools can help to screen protocols for critical risk factors as a starting point
- Compare current protocol against past experience with previous studies
- Information sharing across team members and with partners helps to develop best strategy
[40:15] Common Misconceptions about Risk Based Monitoring
- Common misconception that reducing monitoring can be labeled “risk based” monitoring. It’s all about having a monitoring strategy
- Random selection of subjects/data points for sampling is not a “risk based” approach
- Potential hazards come from cutting monitoring that are not worth the cost savings of reducing effort
[47:02] What causes organizations to be reluctant to adapt risk based monitoring solutions?
- Most companies are doing this in some way, but the approaches were previously very simplified with sometimes limited process
- Auditors, regulators, and inspectors are pushing what is acceptable and driving companies towards more robust processes
- 100% monitoring is okay, but it often comes from companies having unclear/unthoughtful ‘risk-tolerance’
[52:22] Changing Nature of the CRA Role
- CRA role is challenging due to both responsibility and the travel logistics
- Future promises more remote monitoring opportunities
- Dashboards that integrate with critical data fields/risk based fields can be helpful for monitors and staff, but it’s important to ask how it is actionable?
[57:43] Measuring Effectiveness of Risk Based Monitoring
- Reducing missed visits, missed data points, and patient retention are areas where benefits can be seen
- Comparing efficiency of vendors becomes easier when the critical study data is identified in advance
- Statistical confidence improves when there is less “dirty-data” and therefore the total number of patients needed can sometimes be reduced
[1:05:22] Discussing Artem’s Book and Other Recommended Resources
- Introduction to the “Risk-Based Quality Management Guide for Clinical Research”
- Built to both collate experience together working in this field for the last decade as well as to establish simple terms/frameworks we can agree upon for future risk based approaches
- Important to embrace a mistake friendly culture in your organization
- PMI Institute Resources
- Other industries with extensive risk monitoring (air travel/NASA)
- Thinking Fast, Thinking Slow – Kahneman and Tversky
- Fundamental of Clinical Trials – Lawrence Friedman
[1:17:57] Final Thoughts & Episode Wrap-Up
- RBQM as a long-term cultural transformation
- Importance of early investment in quality planning
- Artem’s closing remarks and book giveaway offer
- Closing message from the Clinical Trial Podcast
Major Themes
- Evolution from Risk-Based Monitoring to Risk-Based Quality Management
- Quality by Design and ICH E6(R3) Implications
- Technology, Data Analytics, and the Future Role of CRAs
Selected Quotes
“Risk-based monitoring is not about reducing monitoring — it’s about investing upfront to prevent disasters later.” – Dr. Artem Andrianov
“Inviting different stakeholders that you also thought, Okay, what makes sense to monitor, and what you could leave out of scope, that’s all reasonable steps. That’s all kind of part of the, I would say, standardized process which is supposed to happen.” – Dr. Artem Andrianov
Audience Question
What excites you about the future of risk based monitoring? What challenges do you see ahead in its development?