Metrics Champion Consortium
MetricInsights

Twitter  LinkedIn

January 2021

 

Letter from the Executive Director

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:

  1. COVID-19 Community of Practice / Knowledge Sharing Group
  2. Centralized Monitoring Community of Practice / Knowledge Sharing Group
  3. Centralized and Site Monitoring Process Metric Development Work Group
  4. Audit, Compliance & CAPA Community of Practice / Knowledge Sharing Group
  5. 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

News icon

  Important News

MCC Clinical Trial Optimization Podcast – New Episode Available!
PhoneTestImageThe MCC Clinical Trial Optimization Podcast 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 in a twice-monthly podcast. For more information about the podcast and to view a full listing of show episodes please click here.

EPISODE 12
Deploying Streamlined Surveys and Generating Metrics to Assess Vendor-Sponsor Relationships with Linda Sullivan and Keith Dorricott Listen Now

Subscribe today! Apple PodcastsSpotifyStitcherAndroid

New Monitoring and Site Selection & Start-Up Metrics Available for Review
Two MCC Metric Development Work Groups have draft metrics available for review. Both work groups followed the MCC Metrics Development Framework to determine the most important aspects of these processes that should be measured with metrics. The framework starts with mapping the process, then determining the Critical Success Factors and related Key Performance Questions on the process. Both work groups have good representation from the industry and elements from the rich discussions have been captured in the draft metric definitions, including the key question each metric answers, why each metric is important, how to calculate each metric, recommended performance targets and what to do with the results. The draft metrics definitions are available for anyone in a MCC member organization to review prior to finalization. The metric sets available for review are:

  • Site Selection & Start-Up – this metric set focuses on activities from site activation to patient enrollment. The set includes metrics focused on measuring time for site activation, patient screening, and patient enrollment; site selection quality metrics (related to patient enrollment and patient retention); and cost of enrollment. The set of 36 metrics is posted in the member portal in the Site Selection & Start-Up Metrics Work Group webpage - feedback is due by 23-Feb-2021.
  • Centralized & Site Monitoring – this metric set focuses on risk and issue management. The set includes metrics focused on measuring time aspects of different parts of the process and quality (to determine whether the process is working well). The set of 10 metrics is posted in the member portal in the Centralized & Site Monitoring Metrics Work Group webpage - feedback is due by 11-Feb-2021.

For more information about these metric development work groups, please visit Site Selection & Start-Up Metrics and Centralized & Site Monitoring Metrics.

Does a TMF Completeness Measure Tell the Whole Story?
The MCC Inspection Readiness & TMF Community of Practice Group will meet on 9 February at 11 AM EST to hear a TMF case study “Can a TMF Completeness Measure Tell the Whole Story?” presented by Pfizer’s Mary Emanoil - Head of TMF and Registry Operations, Brenda Brown - Director, TMF Operations Lead and Luann Sager - Director, TMF Operations. Following the case study, group members will discuss the challenges of metric implementation in this area and some learnings.

Additional information about the MCC Inspection Readiness / TMF Community of Practice Group can be found on the MCC website. MCC Members can log onto the MCC member portal to register for the session.


Member news icon

  Member News

MCC welcomes the following new members and thanks those for their continued membership.

MCC newest members are:

  • Ultragenyx
  • ZS Associates

MCC thanks the following members for their renewal:

  • Jazz Pharmaceuticals
  • Saama Technologies

Working group icon

  Featured Work Group

Centralized Monitoring Community of Practice
GraphiconTabletImageYou’ve Detected a Risk – Now What?

The Centralized Monitoring Community of Practice Group is meeting on 20 January 2021 at 11AM EST to discuss the topic “You’ve Detected a Risk – Now What?”.  As the industry has moved to a risk-based approach, it is expected that team members use critical thinking skills to assess the risk and determine whether there is a real issue that needs to be managed. This is a significant change in approach – what are the challenges and the best practices for encouraging adoption of critical thinking in this area?

Additional information about the MCC Centralized Monitoring  Community of Practice Group can be found on the MCC website.  MCC Members can log onto the MCC member portal to register for the session.


Calendar icon

  Upcoming Meetings

MCC Metric Development Work Groups
Members work collaboratively, through structured discussions, to develop and refine metric sets and tools. Work group members are encouraged to regularly participate in monthly, 60-minute web-based meetings. On occasion members will be asked to complete structured reviews and provide feedback outside of meetings (assignments typically require 15-30 minutes to complete).

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

 Work Group
Meeting Frequency
Date
Centralized and Site Monitoring Process Metrics
3rd Thursday of the Month at 11AM ET
Jan 21, 2021
Feb 18, 2021
Mar 18, 2021
eCOA Process Metrics
3rd Tuesday of the Month at 11AM ET
Jan 19, 2021
Feb 16, 2021
Mar 16, 2021
Site Selection and Study Start-Up Metrics
1st Tuesday of the Month at 11AM ET
Mar 2, 2021
Apr 6, 2021
May 4, 2021
*Deviates from regularly scheduled day or time.

MCC Communities of Practice
Members share ideas and practical approaches to address challenges unique to these communities.

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Communities of Practice
Meeting Frequency
Date
Artificial Intelligence (AI)/
Machine Learning (ML)
2nd Tuesday every other Month at 11AM ET
TBD
Audit, Compliance & CAPA
2nd Tuesday every other Month at 11AM ET
Mar 9, 2021
May 11, 2021
July 13, 2021
Centralized Monitoring
3rd Wednesday of the Month at 11AM ET
Jan 20, 2021
Feb 17, 2021
Mar 17, 2021
Consultancy
Quarterly at 11AM ET
Feb 26, 2021 
Inspection Readiness/TMF
Quarterly at 11 AM ET
Feb 9, 2021
Apr 13, 2021
Jun 8, 2021
Small Sponsor Community
of Practice
Every other Month at 11AM ET
Feb 24, 2021
Apr 28, 2021
Jun 23, 2021
Study Quality Trailblazer
2nd Wednesday of the Month at 11AM ET
TBD
*Deviates from regularly scheduled day or time.
 

MCC Implementation Support Group Meetings
Members are provided the opportunity to ask questions and share experiences related to implementing specific metric sets or tools at quarterly web-based meetings.

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Work Group
Date & Time
Cardiopulmonary Metrics
Jan 26, 2021 11AM EST
Central Lab Metrics
Jan 27, 2021 11AM EST
Data Management & Biostatistics Metrics
Feb 23, 2021 11AM EST
Imaging Process Metrics
Feb 4, 2021 11AM EST
Risk Assessment & Mitigation Management Tool
Feb 10, 2021 11AM EST
Site Contracting Metrics
Jan 28, 2021 11AM EST
Vendor Oversight
Feb 3, 2021 11AM EST
 

Connect with MCC at Industry Events 
MCC staff looks forward to having good conversations with you in 2021.

WCG MCC Clinical Trial Risk and Performance Management Virtual Summit
See you September 2021


Ask icon

  Ask the Experts — MCC Answers Your Metric Questions

Meet The Experts

  Keith Dorricott
  MCC Ambassador and Director
  Dorricott Metrics and Process Improvement, LTD




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

Q: Since we implemented Risk-Based Monitoring we have been trying to monitor the process to determine how well it is working. We have developed metrics such as whether alerts from Centralized Monitoring are closed on time but are uncertain what to use as a target. How are other organizations approaching this?

A: With a new or significantly revised process, you should always be asking the question “How will we know whether it is working?” You need to establish measurements that evaluate the process. We applaud your approach! The MCC Centralized & Site Monitoring Process Metrics Work Group has been discussing this exact topic. The work group developed a high-level process map that includes the centralized monitoring and remote/onsite site monitoring processes. The work group identified a series of questions about the process (aka Key Performance Questions) they wished to answer and are working on defining metrics to answer the questions. This approach ensures that MCC metric sets are comprised of metrics that provide actionable data.

The measurement that you state in your question is a type of time metric we call an “on time” or “timeliness” metric. The work group defined an alternative time metric that is a “cycle time” metric - instead of measuring if the task is completed within the timeframe you establish as the target, it measures the actual time it takes to complete the task.

Key Performance Question Draft Metric Performance Target
How long does it take to determine if risks identified in centralized monitoring are issues? Average time from risk identification to issue confirmation TBD

The work group explored the pros/cons of each approach and concluded that the industry doesn’t have enough experience with the new process to determine what the target should be. Using a cycle time metric provides the opportunity for the industry to gather data on the new process and, in time, decide whether it is feasible and useful to have a timeliness metric that measures against a target. Additionally, upon review of the results, we may determine that critical risks should be assessed faster than others. Finally, we don’t want to encourage the premature closures of risks (prior to proper investigation) in order to meet timeliness targets without basis in understanding the process. Whenever metrics are defined and used, it is important to think critically about the purpose of the metrics and the behaviors they might drive.

For more information about this MCC metric development work group, please visit https://metricschampion.org/centralized-and-site-monitoring-metrics-work-group/


Education icon

  Education

WCG Metrics Champion Consortium Expands Its Learning Institute with New eLearning Courses
Addition of Clinical Pathway’s On-Demand, Performance Management and Good Clinical Practice Training Courses Enriches Resources Available to MCC Members

MCC now offers 12 new eLearning courses on performance management and good clinical practice (GCP) developed by Clinical Pathways, LLC to provide stakeholders across the clinical research community with high-quality, effective training resources.
Learn More


Join icon

  MCC Membership and User Accounts

Access to MCC metric sets, tools and other assets are limited to employees of MCC member organizations. Please visit the MCC website or email MCC Membership Director Terry Holland for membership information.

Setting Up User Accounts to Log onto Member Portal
If you work for a MCC member organization, you are welcome to set up an individual user account to take advantage of the benefits MCC Membership offers. Click HERE to start the process.

1f6751a2-5be3-491c-856c-cf2d51c4a008.gif

Join the MCC LinkedIn Group to learn about industry performance metrics and stay informed of new developments.

 
WCG MCC Logo

Metrics Champion Consortium,  300 N. Washington St.,,  Falls Church, VA 22046,  USA 
Phone (617) 948-5100 | Toll free (866) 219-3440

© 2021 Metrics Champion Consortium

 
Untitled Document