Why are QTLs so Difficult to Implement? MCC Panel Discussion on 18 November to Kick-off QTL Exploration
During the MCC Clinical Trial Risk and Performance Management Virtual Summit, a Working Group developed a list of commonly used Quality Tolerance Limit (QTL) parameters and discussed implementation challenges. Summit Working Group participants asked MCC to continue to help the industry develop a practical approach to QTL implementation and use. The 18 November Centralized Monitoring CoP meeting will feature a panel session and open discussion about industry challenges with QTL implementation.
Topic: “Panel Discussion – Industry Challenges with QTL Implementation”
- Artem Andrianov, CEO, Cyntegrity
- Margaret Kutozova, Associate Director, Project Management Centre of Excellence, IQVIA
- Leslie Sam, Principal Consultant, Wool Consulting Group
- Michael Walega, Head of Centralized Monitoring, BMS
- Steve Young, Chief Scientific Officer, CluePoints
The panel will discuss why, four years since adoption of ICH E6 (R2), QTL implementation continues to be such a challenge for organizations. How should you determine QTL parameters and thresholds? When might a deviation count as not being important (and therefore require reporting in the CSR)? What can we do to help organizations implement and use QTLs?
MCC is forming a sub-team of Subject Matter Experts to develop materials to assist organizations with implementation and use of QTLs. Some of the questions sub-team members will discuss include:
- Allowance for study-level KRIs (and general study-level risk and operational/performance monitoring) separate from QTLs
- What constitutes an "important breach" to a QTL (i.e., those that require reporting in CSR)?
- Leading QTL Indicators and proper normalization
- How/where should QTLs be identified for a study (e.g., pre-study risk planning, QBD risk review, both, other)?
- When should QTLs be based on historical data/benchmarks, and when should they be based on "statistical characteristics of variables" (ICH E6 R2 language)?
The sub-team will develop a QTL toolkit to assist organizations in implementation. We are looking for cross-industry representation from sponsors, CROs, vendors and others. Anyone from an MCC member organization is welcome to participate in the discussions.