In the world of clinical research, many of us have heard of Bristol-Myers Squibb (BMS), a well-known global biopharmaceutical company. In a recent article online at Applied Clinical Trials, Thomas Verish, Group Director of Data Operations Services, discusses the risk-based monitoring (RBM) strategy that Bristol-Myers Squibb has begun using.
The company is utilizing the Guidance for Risk-Based Monitoring (RBM), which was released by FDA in draft form in 2011 and was finalized in August 2013. In this document, the basis for RBM is outlined and includes the following:
- Identifying Critical Data and Processes to be Monitored
- Risk Assessment
- Factors to Consider when Developing a Monitoring Plan
- Monitoring Plan:
- Descriptions of Monitoring Approaches
- Communication of Monitoring Results
- Management of Noncompliance
- Ensuring Quality Monitoring
- Monitoring Plan Amendments
At Bristol-Myers Squibb, the process of initiating a risk-based monitoring approach is in the pilot stage. They have created an infrastructure in which roles are defined as follows:
- Data Operations- serve as a data management group
- Centralized Monitors- work on identifying trends in data
- On-Site Monitors- perform site visits and review of source data
These groups also work in coordination with each other. Specifically, Data Operations and the Centralized Monitors work closely together to analyze trends and overall study progress, On-Site Monitors may have visits triggered by issued noted by the Centralized Monitors. Thomas Verish specifically indicated that Centralized Monitors excel at being able to change existing clinical practices as needed; these individuals are also known for having a strong skill set and a firm grasp on Good Clinical Practices.
As with any new internal change, the company admits to having to deal with resistance from existing personnel, due to the necessary infrastructure changes in roles and responsibilities. Also, Verish specifically noted that applying a risk-based monitoring approach does not equal cost savings. The article cited a recent analysis by another company of potential financial savings due to RBM; this found that applying RBM led to less than a 2% reduction in research and development costs. This is important for companies to keep in mind, as the basis for RBM should not mean “less monitoring” or “cheaper monitoring”, just more efficient monitoring.
What do you think of the risk-based monitoring approach adopted by Bristol-Myers Squibb? I’d suggest reading the article noted above and let us know if you have any suggestions for improvement or other items to consider in a RBM plan.
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