Drug development and clinical research are evolving. Researchers are making every effort to improve data safety and integrity. Thus regulators in the US and EU have called for clinical research to shift from the practice of 100 percent source data verification, which is time-consuming and a costly process to risk-based monitoring.
Alexander Artyomenko, MD, PhD, Global Director, Late Phase Clinical Operations writes “RBM is clearly the direction for the future and stakeholders need to position themselves for the brave new world it represents. Sponsors should start working with their CRO partners early in the research process to identify and so as to develop optimal monitoring strategies. Service providers must assess and refine their research process to identify and develop optimal monitoring strategies”. Source- http://www.medpace.com
Benefits of Risk-Based Monitoring
Risk-based monitoring comes with many potential advantages. Some of them are –
- Enhanced patient data safety and integrity
- Efficient and effective protocol design
- Reduces cost of clinical trials
- Helps to adjust the oversight strategically keeping up with the changes in risk-level
How RBM Strikes a Balance for a CRA (Clinical Research Associate)?
A CRA with its deep therapeutic and operational expertise helps in the risk-assessment process and highlights various items within protocol design that might affect the overall risk levels.
With risk-based monitoring, studies and review process have sped up for CRAs. Even querying on clinical data and meeting the accuracy has become easier. CRAs involved in a particular research are responsible for putting RBM into practice. They ensure that all research partners are working on common assumptions and quality benchmarks.
How Does RBM Enable a CRA?
Risk-based management lets a CRA improve his cross-functional expertise to identify, mitigate and monitor risks throughout the clinical trial. Since the risk levels differ, the CRA team members must adopt various technological tools to adjust the changes that arise during a study
- On adopting risk-based monitoring, the CRAs must ensure that they have the tools, training, and feedback to implement RBM effectively. To enable this, CRAs must stay in direct contact with the sites to review the data trends.
- RBM paradigm also empowers a CRA with the ability to recognize, collect and analyze data, using various tools necessary to support the RBM strategy.
Risk-based monitoring has a bright future so sponsors must start working with their CRA partners in the early stage of the research to develop optimal monitoring facilities.