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October 2019

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  Important News

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Save the Date! MCC's 2020 Clinical Trial Risk and Performance Management Summit
The 2020 summit will be September 9-10 in Philadelphia. This year’s summit was a huge success with themes exploring: Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution, Metric Program Implementation, Risk-based Quality Management, Risk-based Vendor Oversight and Applying Critical Thinking Skills to Utilize Metrics Effectively. Please contact MCC Executive Director and Co-Founder Linda Sullivan or MCC Ambassador Keith Dorricott if there are topics you would like to see included for the 2020 summit and if you are interested in participating as a presenter or panellist. Click here to learn more.
 

SiteSelectionImageMCC Launches Site Selection and Start-Up Work Group with Public Meeting
Development of site start-up metrics and results from a public survey were the main topics during a public meeting that relaunched the MCC Site Selection and Start-Up Work Group. The well-attended meeting had 97 participants representing 35 organizations.

Citing data from the Tufts Center for the Study of Drug Development, Linda Sullivan, MCC Executive Director and Co-Founder, discussed the need for a focus on site start-up metrics. Attendees then reviewed the results from a public survey that sought input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes.

Highlights from the survey included:

  • Suggestions for changes to the high level process map which have been added to the “working version” of the high level process map
  • Significant issues in the process that were most selected are related to the time taken for site contracting and site selection
  • Most organizations measure high level cycle times; from site selection to activation and from draft contract sent to contract final
  • Most organizations measure the proportion of sites either not enrolling or enrolling only one patient

After plotting the metrics on the high level process map, the discussion moved to how the interactions between regulatory, ethics and site contracting vary by country and site and should provide context to metric values. The MCC Metrics Development Model was described with reference to the Site Contracting Metrics 1.1, which are available for those in member organizations to download.

The next Site Selection and Start-Up Work Group meeting will be on November 5, 2019 and all future meetings will take place on the first Tuesday of the month. These meetings are only open to MCC member organizations. The work group will be using the MCC Metrics Development Framework to develop a comprehensive metric toolkit that includes basic and advanced standardized metrics that answer key performance questions related to this process.

The MCC encourages members to join the work group! The meetings are a pre-collaborative space for you to meet your industry peers, share experience and develop metrics to help our industry.

Members can register for the November 5 meeting by visiting the Site Selection and Start-Up Metrics Work Group page on the MCC member website or contact Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.
 

MCC eCOA Metric Updates Under Consideration
MCC members recommended making changes to the eCOA Metric Toolkit v2.0 during the October Implementation Support Q&A meeting. Updates being considered include modifying the performance targets to the red-yellow-green format, adjusting the definitions of metrics 4a and 4b, and determining which of the metrics could potentially be used as Risk-Based Quality Management Key Risk indicators.

Based on this feedback, the MCC will draft proposed updates and provide an opportunity for member organizations to review the changes. The eCOA Metric Development Work Group will be relaunched to discuss the feedback, agree on the changes and the MCC will publish the updated eCOA Metrics Toolkit.

MCC members should visit the eCOA Work Group page on the member website for additional information.
 

MCC Membership Fees Increasing in 2020 – Act Now to Lock In 2019 Rates!
MCC thanks our members for their support to develop standardized process performance metrics and tools to improve clinical trials. Together, we are working to achieve our mission to bring clinical research stakeholders together, including sponsors, CROs, partners and investigational sites, to collaboratively develop standardized performance metrics and associated tools that help organizations oversee, manage and optimize clinical trial execution. Over the last 13 years, our focus has expanded beyond the original time, cost and quality metrics to include risk-based quality management and protocol operational quality tools. MCC has become the place to meet industry peers, exchange ideas, collaborate and think.

Today, MCC programs support the mission through helping organizations:

  • Gain insights about what others are doing.  Interactive communication among our members participating in surveys, best practice community discussions and metric development work group activities allows for multi-industry stakeholders, including sponsors, CRO’s, sites and vendors to share ideas in a pre-competitive environment to learn how to work together more effectively. 
  • Define what to measure.  MCC metric experts facilitate member-only work groups that develop/update performance metrics and risk/quality tools. Members report that participation in the virtual work groups is a high value activity.
  • Determine which metrics are right for their program and how to communicate selection with other stakeholders.  During the last 12 months, MCC has invested in developing implementation support resources to help small, medium and large organizations select the right MCC metrics for their programs. This significant breakthrough has been highly praised by members and will be rolled out across the metric sets in 2020. Specifically, four new metric selection tools allow users to select MCC metrics based on the following criteria:
      • Key performance questions they are trying to answer
      • Issues they are trying to manage
      • Basic-level vs. advanced-level metrics
      • Data they have readily available
  • Learn how to implement risk-based quality management and performance metric programs.   Successful implementation of risk-based quality management and performance metric programs requires both selecting the right metrics and tools AND training staff to use metrics and tools to effectively manage your programs. The MCC Learning Institute eLearning program offers foundational training in two tracks: Mastering Risk Management and Mastering Performance Metrics, including a Metric Master Certificate program. MCC members receive a discount on single and group e-courses rates. Some members have licensed the e-courses for use on their internal learning management systems.

In order to continue to provide these benefits including the most current metrics and toolkits, detailed and user-friendly implementation tools, facilitated interactive work groups, access to industry subject matter experts, industry reports and white papers, and on-line education, we will be increasing our membership rates beginning January 1, 2020.

In 2020, our fees will go to support the development of the following:

  • New metric toolkits (e.g. Vendor Oversight Financial Metrics, Site Selection and Study Start-Up Metrics, and Centralized and Site Monitoring Process Metrics)
  • Review and updates of existing metric toolkits including ECG, eCOA and Imaging metrics
  • Release of an expanded version of the Protocol Operational Complexity Scoring Tool that generates study management, site and patient burden scores
  • Release of version 3.0 of the Risk Assessment and Mitigation Management Tool
  • Development of metric selection tools for all our metric sets
  • Expansion of the MCC Knowledge Portal
  • Hosting of Subject Matter Expert Webinars

We will continue to offer our three tiers of membership – Silver, Gold and Platinum. If you would like information on the benefits and pricing for each level, please contact MCC Membership Director, Teresa (Terry) Holland at tholland@metricschampion.org. If you would like to join the MCC, lock in your 2019 rate for next year, or would like to learn more about multi-year agreements and discounts, Terry will be happy to help you. Thank you again for your support of the MCC!


Member news icon

  Member News

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

MCC’s newest members are:

  • PM Clinical Quality Consulting Limited
  • Voyager Therapeutics

MCC thanks the following members for their renewal:

  • Regeneron

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  Work Group

MetricsImageMCC Centralized and Site Monitoring Process Metrics Work Group October 17 Kick-off Meeting Open to Public
This new work group will develop a set of detailed metrics that assess new risk-based monitoring processes being implemented to align with ICH-E6(R2) requirements. MCC will use the MCC Metric Development Framework to establish metrics that answer the most important performance questions that members have about the process.

The work group will explore the following topics:

  • The process of site monitoring – including on-site and central
  • Perspectives of member organizations on the important questions the metrics should answer (Key Performance Questions)
  • Metrics for site monitoring – both on-site and centralized
  • Metrics at site, country, study and portfolio levels
  • Metrics for timeliness and quality as well as for cycle time
  • The site monitoring metrics from the existing Clinical Trial Performance Metrics set v1.3 and feedback from the survey

Everyone is welcome to attend the kick-off meeting on Thursday, October 17, 2019 at 10 AM EDT

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Meeting Prep

BlueTakeSurvey We are seeking input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. This information will be used to help ensure the metrics we develop are in line with industry needs in this important area.

Survey respondents will receive a summary recap of results. Your survey responses will be kept confidential.


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  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 Metrics
3rd Thursday of the Month 10AM EST
Dec 5, 2019*
Jan 16, 2020
Feb 27, 2020*
Imaging Performance
3rd Tuesday of the Month 10AM EST
Nov 13, 2019*
Jan 21, 2020
Feb 25. 2020*
Site Selection and Start-Up Metrics
1st Tuesday of the Month 10AM EST
Nov 5, 2019
Jan 14, 2020*
Feb 4, 2020
Vendor Oversight
1st Wednesday of the Month 10AM EST 
Nov 6, 2019
Jan 8, 2020
Feb 5, 2020
*Meeting date deviates from regularly scheduled frequency.
 

MCC Best Practices Communities
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!

Best Practice Community
Meeting Frequency
Date
Centralized Monitoring
3rd Wednesday of the Month 10AM EST
Nov 12, 2019*
Jan 22, 2020*
Feb 12, 2020*
Small Sponsor Community
of Practice
Every Other Month 11AM EST
TBD
Study Quality Trailblazer
2nd Wednesday of the Month 10AM EST
Nov 13, 2019 at 11AM EST**
*Meeting date deviates from regularly scheduled frequency.
**Meeting time deviates from regularly scheduled frequency.
 

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.

 Metric Set/Toolkit Implementation Q&A
Date & Time
Cardiopulmonary Metric Toolkit v2.1 (ABPM, ECG, Spirometry)
Mar 4, 2020 11 AM EST
Central Lab Metrics v3.0
Mar 11, 2020 11 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Mar 10, 2020 10 AM EDT
eCOA Metric Toolkit v2.0
Mar 4, 2020 10 AM EST
Risk Assessment & Mitigation Management Tool v2.0
Mar 12, 2020 10 AM EDT
Site Contracting Metrics Toolkit v1.0
Mar 11, 2020 10 AM EDT
TMF Metrics Toolkit v2.0
Mar 10, 2020 11 AM EDT

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

Connect with MCC
MCC staff looks forward to having good conversations with you in 2019.

MAGI’s Clinical Research Conference – 2019 West

Date: October 27, 2019
Location: Las Vegas, Nevada

Session Title: Sponsors of Choice/Sites of Choice: Measuring What Matters

Session Participants:

Cerdi Beltre – Senior Vice President, Strategic Site Services – WCG
Linda Sullivan, MBA – Co-founder an Executive Director, Metrics Champion Consortium

Session Title: Site, Sponsor and CRO Metrics and Benchmarking

Session Participants:

Bishoy Anastasi, MPH MBA CCRP – Director, Clinical Research Finance – University of California Los Angeles
Cindy Carter – President – CenterWatch
Michael Farley, BS MBA PMP – Associate Director, Quality and Compliance – Alexion USA
Linda Sullivan, MBA – Co-founder and Executive Director, Metrics Champion Consortium

Learn More

 

Clinical Trials Europe 

Date: November 21, 2019
Location: Barcelona, Spain

Session Title: “The Impact of Risk-based Quality Management on Vendor Oversight”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

Learn More


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: We have recently changed our site monitoring process significantly by introducing centralized monitoring and changing the frequency of site monitoring visits based on risk. But our metrics measure against the traditional model with regularly scheduled monitoring visits. Does the MCC have any metrics to recommend for us to use in the “new world” of Risk-Based Monitoring?

A: This was a major topic of discussion in one of the breakout groups at the MCC Summit in September. Many organizations are struggling with this – they have counts of activity but lack real value-added metrics. The overwhelming view was that we, as an industry, need metrics that help us to understand how well the new risk-based monitoring processes are being executed. These updated metrics can be used as input into process oversight and highlight opportunities for process improvement efforts. The MCC’s existing site monitoring metrics need to be updated to reflect the realities of the world of Risk-Based Quality Management. To that end, we are launching the MCC Centralized and Site Monitoring Process Metric Development Work Group on October 17, 2019. The launch meeting is open to the public (see Featured Work Group).


Education icon

  Education

Learn the Fundamentals of Risk-Based Quality Management through MCC’s eLearning Course 301
Quality management methods used to assure and control the quality of clinical trials should be proportionate to the risks inherent in the trial and the importance of the information collected. MCC’s eLearning Course 301 – Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management will help organizations understand risk-management concepts.

Presented by Linda Sullivan, MCC Co-Founder and Executive Director and Keith Dorricott, MCC Ambassador, this one-hour, hands-on, on-demand training course walks through risk management concepts, and learners apply the concepts by reviewing a case example and completing the risk assessment and control log included in the course material. All MCC members receive a 20% discount!

At the conclusion of the course, learners are be able to:

  • Explain the concept of risk and its management
  • Describe risk management in clinical research and the relevance of ICH E6(R2)
  • Identify critical data and processes and use process maps to identify areas of risk
  • Develop risk statements and evaluate risk
  • Describe approaches to controlling risks in clinical research
  • Mitigate some common implementation challenges

To comply with ICH E6(R2), organizations have to develop and implement risk-based quality management programs. Discover how with MCC’s Risk-Based Quality Management eLearning course.

Learn more about the MCC e301 eLearning course.


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  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.

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

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

© 2020 Metrics Champion Consortium

 
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