Developing Critical Thinking Within Centralized Monitoring Teams

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.

What is critical thinking?

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

How to develop critical thinking within CM teams

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

• Knowledge: Formed by experiences, history and what we observe and learn through others, knowledge is the foundation of critical thinking. In CM teams, knowledge areas include clinical trials, GCP and regulation, risk management, data management, analytics and data science. Both passive and active learning²—reading, hearing and watching versus collaborative workshops, respectively—should be employed here. External collaboration groups can be found through professional public sources and RBQM providers, while internal knowledge exchange efforts can be enhanced through engaging with external experts. 
• Comprehension: Comprehension occurs by connecting company processes, risk strategy, analytics and study design. Many of these elements are reflected in standard operating procedures (SOP), risk assessment categorization tools (RACT) and other plans. Connecting risk-indicator (KRI) definitions to the process steps, case report forms (CRF), protocol assessment schedule, study endpoints, safety and design is essential here. Risk indicators can be designed differently in terms of methods and elements, either through normalizations, study phases, randomization or cohorts. CM teams can assess their comprehension level by evaluating how risk category, risk indicators and events are connected; how study design affects risks throughout the study; what indicator elements are referenced in study and process documents; and what the main outcome of the centralized monitoring review should be.
• Application: Shadowing an experienced colleague is a valuable way to transition onto the Application phase. This is the initial step in forming questions and represents the point when mentoring and active discussions become beneficial for understanding the process. Continuing the business cases and lessons-learned review complements the ability to apply acquired knowledge.
• Analysis: Analysis typically includes categorizing, examining and comparing risk factors, among a multitude of other activities; these steps contribute to having a structured approach, which helps direct the flow of thinking. Being an operational aspect of RBQM, CM is deeply rooted in quality management. The Pareto Principal and Fishbone diagrams (figure 4) are widely used in both quality and risk management areas, since their cause-and-effect themes help organize root-cause-analysis investigations. Such diagrams allow CM teams to develop initial assumptions quicker while allocating more time to investigate less common risk signals. Based on our experience, most causes arise from people, data and analytics, systems, process and documents, and environments.

Figure 3. Fishbone diagram of root-cause analysis of RBQM signals

• Synthesis: Synthesis is the ability to apply knowledge, provide meaningful outcomes and see the big picture. At this point, central monitors will start composing a risk story based on the hypothesis. Continuing to be mentored and participate in collaboration groups and historical risks reviews are highly recommended here. CM teams at this stage should consider what other assumptions can be made; if risk signals and assumptions align with processes, documents and trainings; how risk signals differ across entities; and further investigation needs.
• Evaluation: Through producing a final report and assessing the outcome, the evaluation stage concludes the critical thinking cycle and overall process. Still, continuing open discussions among teams is one of the best ways to support and expand the team knowledge and understanding of the risk-based monitoring approach, while external collaboration groups can enhance, benchmark and gain some comfort in this area.

Moving forward

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.

References

1. https://www.isetl.org/ijtlhe/pdf/IJTLHE55.pdf?pagewanted=all
2. https://sites.google.com/site/andreasportfoliopedagogy/7-passive-vs-active-learning