Dear Colleagues and Friends:
As we begin a new year, I reflect on the role the consortium has played in connecting people during the COVID-19 pandemic, the important work the consortium completed in 2020 and the work we are planning to engage in over the next year. MCC continues to provide a unique place where clinical research stakeholders can be part of a community working together to share ideas, solve common problems, define performance measures, develop risk and quality scoring tools and discuss how to use metrics as the foundation to drive process improvement. During 2020, MCC’s global, virtual community was a critical channel for many people to connect with their peers to exchange ideas and learn from each other. Between March to June, MCC hosted weekly virtual meetings where members discussed how the COVID-19 pandemic was impacting clinical trial operations – the discussions are summarized in a 32-page document available in the member portal. In addition to the COVID group, MCC supported 16 additional groups (learn more). In total, MCC hosted 90 work group virtual meetings - an increase of 60% over 2019 and more than 5000 individuals participated in work group meetings – nearly 200% growth over 2019. The most popular groups were:
- COVID-19 Community of Practice / Knowledge Sharing Group
- Centralized Monitoring Community of Practice / Knowledge Sharing Group
- Centralized and Site Monitoring Process Metric Development Work Group
- Audit, Compliance & CAPA Community of Practice / Knowledge Sharing Group
- Site Selection and Start-Up Process Metric Development Work Group
Another milestone for MCC was the launch the Clinical Trial Optimization podcast show in July 2020. The show brings together clinical research stakeholders to exchange ideas, share knowledge, and think creatively about how to oversee, manage and optimize clinical trial planning and execution. To date, we have discussed a broad range of topics in a twice-monthly podcast – I encourage you to subscribe today (learn more).
A record number of attendees participated in the MCC Risk and Performance Management Summit in September 2020 (learn more). We received very positive feedback about the topics covered as well as the experience of participating in virtual discussion groups that used white board technology to gather input and share knowledge. The keynote session, A Regulatory Compliance Perspective on Improving Clinical Trial Quality, Protection of Trial Participants, and Data Integrity, featured Dr. Jean Mulinde, Policy Advisor from the FDA’s Clinical Compliance Evaluation Division, CDER. During her session, she shared her thoughts about the following topics:
- What clinical research industry stakeholders should keep in mind when implementing quality-by-design and risk-based quality management programs,
- Whether FDA has seen a shift in inspectional findings that suggest good clinical practice compliance and data quality are improving,
- How CDER uses submission data to quantify risk to determine where to conduct BIMO inspections, and
- The impact of the COVID 19 pandemic on clinical trial quality
Dr. Mulinde closed her session with a case study that highlighted the importance of quality by design and risk-based monitoring and the value of having good documentation. The message in her concluding remarks left no doubt about the need for us to embrace change … she challenged us to shift our thinking away from concerns about implementing RBM to what will happen if you don’t embrace and implement QbD and RBM and FDA raises data integrity issues that traditional monitoring methods did not identify?
Looking ahead to 2021, MCC will continue to play an important role in the industry. The consortium will work together to complete the development of the site selection and start-up, and centralized/onsite monitoring process metric toolkits. A portion of these metric sets will be finalized in Q2 and additional metrics will be developed throughout the year. In addition to metric development activities, consortium members are drafting a Quality Tolerance Limits position paper, developing an issue/risk categorization framework and updating the Protocol Operational Complexity Scoring Tool. Vendor oversight will continue to be an area of focus as we develop additional training and communication tools to support the use of the metric sets. Finally, we are preparing to launch a new Community of Practice Group that will be a place for members to share knowledge and best practices about improving Patient Diversity in clinical trials!
We welcome your ideas, input and feedback. On behalf of the entire MCC team, thank you for your support and participation. We look forward to working with you in 2021 and beyond.
Linda B. Sullivan