By Ashok Ghone, Ph.D., Vice President, Global Services, MakroCare USA
Risk assessment and management are two key aspects of implementing risk-based oversight (RBM). RBM is about taking a holistic approach to assess all possible risks associated with your study / program, then having an appropriate risk management plan that includes systematic monitoring and risk control / mitigation throughout the conduct of your study. ‘a study / program. Correct identification and assessment of study-specific risks, categorization and implementation of risk-based study-specific monitoring plans are essential elements to ensure high quality, integrity of studies. data, better protection of human subjects, creation of operational efficiencies and optimization of costs. The surveillance plan should clearly indicate how to monitor and control / mitigate high, medium and low risks related to data, study conduct and clinical investigations using various surveillance approaches (centralized, on-site and off-site) . The complexity of the study design, target disease population, endpoint assessments, study phase, study geographic area, and technology used are important factors to consider when developing an effective monitoring plan.
Key aspects of an RBM plan:
- Define key risk indicators: A results-based management plan must define the key risk indicators, their parameters and the corrective action thresholds on the basis of the identification and assessment of the risks carried out.
- Description of monitoring approaches: A risk-based surveillance plan is different from a traditional surveillance plan because it uses various surveillance approaches such as centralized surveillance, on-site surveillance, and off-site surveillance, and also shares responsibilities with various cross-functional resources. It should clearly describe the monitoring approaches to be used with respect to what needs to be achieved through centralized monitoring and what needs to be done during on-site visits and off-site monitoring to control and mitigate various types of risk / problems. A results-based management plan is considered a “dynamic” plan, as the frequency and extent of on-site and off-site monitoring activities will vary depending on the findings of critical risks / issues, site performance, the quality of future data. from different sites, and the identification of new risks. For example, sites that are not performing well or have more quality issues will receive more attention or site visits than sites that are performing as well or better than expected. A results-based management plan should also suggest the process for handling key unresolved issues or significant instances of site non-compliance.
- The roles & Responsibilities of various functional areas: Developing and implementing an RBM plan requires expertise in cross-functional areas such as clinical operations, medical team, data management team, biostatisticians and technology group. The roles and responsibilities of a central monitoring team, on-site monitors, data management and technology groups must be clearly defined for a successful implementation of risk-based monitoring.
- Communication plan and documentation: The RBM plan should describe the system / tools used to document centralized monitoring activities. It should clearly describe the communication plan for the different stakeholders and the documentation process for centralized monitoring reports, escalation of issues, coordination between the centralized monitoring team and on-site monitors or relevant stakeholders for risk control or problem solving. A proper communication plan is crucial for global studies. Likewise, effective coordination between data management, technology and central monitoring teams is important to ensure rapid identification of risks. The RBM plan should also mention the events for which a plan needs to be revised based on the identification of new risks and changes to the protocol, etc.
- Technology used: The RBM plan should include information on the technology / tools used and the different sources that provided the relevant data to create planned analysis reports to monitor risks / issues related to data quality, security patients and trial operations.
- Global quality management: The plan should explain the training requirements for the modified process, in particular with the introduction of a centralized monitoring process. Quality monitoring, efficiency measures and planning audits are useful for strengthening overall quality and evaluating the RBM implementation process.
Using appropriate and validated technology and working with sites to ensure timely data entry and a comprehensive data management plan in line with the monitoring plan are essential aspects of development and implementation of an RBM approach.
Ashok Ghone, Ph.D. is Vice President of Global Services at MakroCare USA. He has 20 years of experience in the pharmaceutical and clinical research industry. Ashok has a strong understanding of global clinical research with hands-on experience in clinical operations, project management, clinical trial management, process development, site management, and patient recruitment activities. He has successfully led various cross-functional teams providing strategic direction and advice to accomplish local, regional and global projects involving early and late phase clinical studies in various therapeutic areas. Ashok has been involved in the development of processes, systems and training programs related to risk-based surveillance and centralized surveillance at MakroCare, which provides these specialized services to biopharmaceutical and medical device companies to support their efforts in the implementation of the RBM approach.