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Developing a higher level of critical thinking can create a comprehensive risk story and properly direct mitigations throughout your organization.
Since the FDA published its report, “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” in 2011, risk-based monitoring (RBM) has become a guidance document that lays out the FDA’s expectations. Later on, the European Medicines Agency (EMA) adopted ICH E6 (R2) and made it a requirement.
Although robust centralized monitoring (CM) ensures risk-based quality monitoring (RBQM) success, regulatory agencies often provide a general framework to this process without specifying exactly how it should be done. Due to the complexity and a lack of guidance within RBM, it’s crucial that CM teams develop critical-thinking skills to effectively run these operations. Critical thinking helps CM teams understand root causes, reduce the rate of false positive signals, determine next steps in an investigation and recommend risk mitigations.
While plenty of skill-based CM trainings exist for clinical trials, Good Clinical Practice (GCP), regulation and data management, critical-thinking education has yet to arrive and require more complex approach involving variety of formats and activities. Through our research, we found that the ability to develop critical thinking is not only possible but can help pharma companies in being more efficient in their overall RBM strategy, from more accurate decoding of the risk signals and mitigation actions up to the continuous improvements, and improved retention ability.
Critical thinking has many definitions and interpretations, which makes it hard to grasp. Benjamin Bloom’s taxonomy model offers a practical approach to understanding where and how critical thinking occurs. The model provides a hierarchy for achieving a higher order of thinking through knowledge, comprehension, application, analysis, synthesis and evaluation.
Figure 1: Bloom taxonomy pyramid for higher order thinking
The best way to enhance CM critical thinking is through a combination of learning and practicing opportunities, which the International Journal of Teaching and Learning in Higher Education1 says is achievable through determining objectives; encouraging discussions and questions; allowing active learning; reviewing, refining and improving processes; and providing feedback.
Applying this framework to the Bloom taxonomy pyramid can create a practical approach to the team development of and training strategy for critical thinking (figure 3).
Figure 2. Bloom taxonomy centralized team activities and examples
Figure 3. Fishbone diagram of root-cause analysis of RBQM signals
In the RBQM world, it’s easy for CM teams to get caught up in the review of isolated key risk indicators (KRI) or use a one-size-fits-all framework to address risks across the portfolio. Doing so—and losing sight of the big picture and impact of the study design—provides a fragmented viewpoint and will eventually mislead everyone. By developing this higher level of critical thinking, CM teams can create a comprehensive risk story and properly direct mitigations throughout their organization. Additionally, it promotes a culture of honest discussions and open-mindedness to support RBQM ecosystem in your organization. Moving forward, the more CM teams develop their critical thinking capabilities, the more they’ll maximize RBQM efficiency and effectiveness.
Vera Pomerantseva, MS, PMP is quality and risk management lead in ZS’s Princeton Office.