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January 2019

 

Letter from the Executive Director

Dear Colleagues and Friends:

As we begin a new year, I am excited about what we accomplished in 2018 and the work we are planning to engage in over the next year. Here are highlights of work completed in 2018:

  • MCC hosted the MCC Risk and Performance Management Summit in November. The two-day event received rave reviews – details about the 2019 Summit will be available soon. 
  • MCC’s Study Quality Trailblazer and Centralized Monitoring Work Groups released deliverables that are major contributions to the industry’s advancement in strategies and tools for implementing risk-based quality management and centralized monitoring programs that align with ICH E6(R2) expectations. The MCC Risk Assessment and Mitigation Management Tool v2.0 has new features that focus on analyzing risk related to critical data and process, and the Centralized Monitoring Guidance document provides insights about how organizations are implementing centralized monitoring programs.
  • The release of the MCC Site Contracting Metrics v1.0 Toolkit marked a major milestone for MCC.
    • The metric definitions were developed in a few months using a new proprietary approach – The Metric Kaizen Approach. 
    • The metric set includes MCC Global Start-Up Comparison Models that group countries based on how the site contracting process is impacted by country-specific regulatory approval and ethic review processes. This allows users to consider the context within which the contracting process takes place and constraints that may make it difficult to improve results.
    • New implementation support tools such as an implementation guide and three metric selection tools (metric to data elements; data elements to metric; issue to metric mapping tools) were introduced with the metric set. The tools were so well received that similar tools will be developed for other MCC metric sets.
  • The scope of areas covered by the Vendor Oversight Metric Toolkit expanded to include Vendor Oversight Milestone Metrics and Vendor Oversight Relationship Assessment Metrics. The set will be further expanded in 2019 to include Vendor Oversight Quality Metrics, Governance Metrics and Financial Metrics.
  • Several metric sets were updated to version 2.0, including: eCOA, Data Management, Biostatstisitcs and Medical Writing, and Trial Master File.

Looking ahead to 2019, MCC will continue to blaze new trails in the risk, quality and operations areas. The MCC Risk Assessment and Mitigation Management Tool will evolve as MCC’s Work Group explore areas of risk within processes and identify new ways to identify site and study level risks through innovative Key Risk Indicators. To further support the implementation of risk management approaches, MCC will offer an online course Fundamentals of Clinical Trial Risk Management - Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2).

Finally, MCC will reconvene the MCC Clinical Operations Work Group to review and update the Clinical Operation Metrics to ensure they align with ICH E6(R2) and risk-based monitoring.

On behalf of the entire MCC team, thank you for your support and participation. We look forward to working with you in 2019.

Linda B. Sullivan

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Important News

MCC Imaging Metrics and Quality Risk Management Online Meeting to Discuss Key Risk Indicators is February 12
MCC members are invited to an online meeting on February 12, 2019 to learn about the cutting edge work being discussed in the MCC’s Central Lab Metrics Work Group and the opportunity to expand the discussion into the Imaging Metrics Work Group.

This reconvening work group will review the Imaging metric set and explore opportunities to use data from the collection and analysis of imaging scans to provide a signal of risk at individual sites or for the study. Specifically, the work group will explore the following:

  • Look at the image collection and analysis process from the perspective of Quality Risk Management as defined in ICH E6(R2) section 5.0 and define the process steps of highest risk
  • Review existing metrics and determine which could be used as Key Risk Indicators and whether there are metric gaps for the high risk process steps
  • Update the existing metrics to add information now included in other MCC metric sets such as, what the metric does not tell you, metric level (portfolio, study, site), data elements, advanced/basic metric designation
  • Develop implementation support tools – similar to those already in use with other metrics sets – including:
    • Sponsor/vendor metric selection tool
    • Common issues to metric mapping tool
    • Implementation case studies

The Imaging Work Group will hold one-hour virtual meetings on a monthly basis. This meeting will be of interest to people who manage Imaging Core Lab services, Imaging data and/or quality risk management, including risk management, centralized monitoring and/or risk-based monitoring. Participating in this MCC work group is a great opportunity to share your experience with other clinical trial professionals across the industry and to help shape the industry approach to use of imaging data for quality risk management in the future.

MCC members interested in participating in the Imaging Work Group meeting can click here to register.
 

Attending the SCOPE conference? Connect with Linda Sullivan and Keith Dorricott
MCC Executive Director Linda Sullivan and MCC Ambassador Keith Dorricott look forward to participating in the Summit for Clinical-Ops Executives (SCOPE) in Orlando, FL, February 18-21.

Linda will moderate an interactive breakout discussion, Monitoring and Quality - Vendor Performance Metrics and KPIs, on Tuesday, February 19 at 4:10 pm, and participate as a panelist during the session, Ensuring Harmony Between all Stakeholders – Sponsors, CROs and Site – When Site Sourcing, on Wednesday, February 20 at 8:55 am.

Contact Linda or Keith if you would like to set up a time to meet during the summit.

Learn more about SCOPE 2019
 

Central Lab Draft Metrics and Key Risk Indicators Ready For Review
The Central Lab Work Group announced that the spreadsheet with 30 metrics that have been drafted from database set-up through to final data transfer are ready for review, with 13 of the metrics identified as possible Key Risk Indicators (KRIs).

The proposed study and site-level KRIs use the data collected by central labs to help assess risk per ICH E6(R2) section 5.18.3. The spreadsheet includes detailed definitions of each KRI metric and how they can be used, a glossary and a process map showing which part of the process the metrics are focused on.

Additionally, the work group has reviewed metric selection tools developed in other metric sets and decided to draft those for the Central Lab set, too. The tools include the matrices showing recommended metrics depending on specific issues, required data elements based on metrics selected, and a worksheet for use between a sponsor/CRO and service provider to agree the metrics to be tracked.

The seven new metrics that have been added to the set are also open for public consultation. MCC member and non-member organizations can review and provide feedback. Respondents who complete the survey and provide their details will receive an executive summary of the results. Please respond by February 12, 2019.

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For more information, contact work group facilitator and MCC Ambassador Keith Dorricott.
 

Vendor Oversight Work Group Finalizing Quality Metrics
Representatives from more than 15 organizations collaborated to finalize the Key Performance Questions for the Vendor Oversight Metrics Toolkit.

During the January work group meeting, one member shared their recent experience of an inspection that focused on CRO oversight. The work group discussed how metrics can be used to help show a trend of improvement (or otherwise) over time.

The draft set of 15 quality metrics are available for download for MCC member organizations to review. Please provide your feedback to group facilitator and MCC Ambassador Keith Dorricott by January 31, 2019. The Vendor Oversight Work Group will review all feedback at the February meeting.


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Surveys

Central Lab Draft Metrics Open for Public Review
MCC is seeking feedback from both MCC members and non-members to seven newly developed metrics that have been added to the Central Lab metric set.

The one-page survey will seek input on if the new metrics are valuable, used by organizations today and how easy they are to calculate.

Respondents who complete the survey and provide their details will receive an executive summary of the results. All feedback will be confidential. Please respond by February 12, 2019. Thank you for your participation!

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Member News

MCC Membership Increasing as Consortium Welcomes New Members
MCC welcomes the following new members and thanks those for their continued membership.

MCC’s newest members are:

  • Bristol-Myers Squibb
  • CTCC Services – Ed Campanaro – MCC Ambassador
  • Debiopharm International SA
  • Harper CRC – Debbie Harper - MCC Ambassador
  • MAPS Public Benefit Corp
  • Sarepta Therapeutics

MCC thanks the following members for their renewal:

  • Comprehend Systems
  • PRA Health Sciences

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Featured Work Group

The MCC Data Management & Biostatistics Work Group Reconvenes January 22 to Explore Key Risk Indicators
The MCC Data Management, Biostatistics & Medical Writing Metrics v2.0 was released in August 2018 with a significant update to the metrics. As other work groups have focused on the implementation of Quality Risk Management in ICH E6(R2), possible gaps in the Data Management metrics have been identified.

During the meeting on January 22, 2019, participants will review the approach of those work groups, in particular Central Labs, and consider whether there are gaps in their metric set. The work group will explore metrics that could act as Key Risk Indicators – indicators of risk at site or study level – that could be used to help focus efforts to averting issues in data integrity and/or subject safety.

MCC members can register for the meeting by logging into the MCC site. Contact group facilitator and MCC Ambassador Keith Dorricott for more information about the MCC Data Management & Biostatistics Work Group.


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Upcoming Meetings

MCC Monthly Work Group Meetings
Meetings are open to participants from MCC member organizations. To register for a work group meeting or for a detailed list of meeting dates and times, please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Work Group Meeting
Frequency
Date
Central Lab
1st Tuesday of the Month at 10AM EDT
Feb 5, 2019
Mar 5, 2019
Apr 5, 2019
Centralized Monitoring
3rd Wednesday of the Month at 10AM EDT
Feb 20, 2019
Mar 20, 2019
Apr 17, 2019
Imaging Performance
3rd Thursday of the Month at 10AM EDT
Feb 12, 2019*
Site Selection & Start-Up
2nd Thursday of the Month at 10AM EDT
TBD
Study Quality Trailblazer
2nd Wednesday of the Month
at 10AM EDT
TBD
Vendor Oversight
1st Wednesday of the Month
at 10AM EDT
Feb 6, 2019
Mar 6, 2019
Apr 3, 2019
*Meeting deviates from regularly scheduled frequency.
 

MCC Metric Sets and Tools Implementation Support Group Meetings
These newly created meetings will be held on a quarterly basis to provide MCC members the opportunity to ask questions and share experiences related to implementing specific metric sets or tools.

 Metric Set/Toolkit Implementation Q&A
Date & Time
Data Management, Biostatistics & Medical Writing Toolkit 2.0
Mar 12, 2019 10 AM EDT
Site Contracting Metrics Toolkit 1.0
Jun 13, 2019 10 AM EDT
TMF Metrics Toolkit 2.0
Jun 11, 2019 11 AM EDT

 

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

SCOPE: Summit for Clinical-Ops Executives 2019
Tuesday, February 19, 2019 (4:10 pm)
Interactive Breakout Discussions: Monitoring and Quality - Vendor Performance Metrics and KPIs
Moderator - Linda Sullivan, MCC Co-Founder & Executive Director

Wednesday, February 20, 2019 (8:55 am)
Ensuring Harmony Between all Stakeholders – Sponsors, CROs and Site – When Site Sourcing
Panelist – Linda Sullivan, MCC Co-Founder & Executive Director

Learn more about SCOPE 2019

MCC’s Linda Sullivan to Present at the Evolution Summit
MCC Executive Director Linda Sullivan will moderate The A-Z of Risk-Based Monitoring (RBM): Strategies for the Future during the invitation-only Evolution Summit February 24-26, 2019 in Rancho Mirage, CA.

As the clinical trials industry continually evolves, Linda will discuss how novel strategies must be implemented in an effort to operate efficiently and ultimately accelerate drugs to the market. A more centralized, risk-based approach to site monitoring has presented itself as one viable method of reducing costs. Linda’s topics for discussion include:

  • Implementing a well-designed RBM strategy that enhances, while supporting, traditional monitoring approaches
  • Tools needed to execute the strategy
  • Overcoming challenges and the benefits to be realized

Click here for more information on the 2019 Spring Evolution Summit.


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  Ask the Experts

MCC Answers Your Metric Questions
Q: Our company has a goal of speeding up clinical research and we’ve been developing our approach to metrics with this outcome in mind. We have collected metrics looking at how long different parts of the process take but a consultant (an MCC Ambassador) recommended we consider other metric types too – in particular quality. Quality is critical, of course, but our goal is to make clinical trials faster. Do you think we should have metrics for quality too?

Meet The Experts

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




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

A: Your MCC Ambassador is right to caution you against focusing solely on time-based measures. The key to reducing timelines is to remove non-value added work. In other words, avoid protocol amendments, rework, retraining, rescues sites, etc. This is the reason that MCC always recommends a combination of time, cost/efficiency and quality metric types. If you focus on just one, such as cycle time in this case, you may have unexpected consequences on cost and/or quality. For example, when reducing the cycle time to reach a final protocol, you might inadvertently discourage the team from taking the proper time to review the protocol and ensure the best possible quality before study start. This could lead to quality problems, namely avoidable amendments, later in the study with a much larger impact on overall cycle time and cost. The ICH addendum, ICH E6(R2) section 5.0, is very much trying to get the industry to build in quality by design rather than rushing to get started resulting in errors that then need correcting. There are a number of academic studies looking at the costs of poor quality such as the costs of avoidable amendments, non-core procedures, low enrolling sites, subject withdrawals etc. MCC’s Study Quality Trailblazer Work Group developed a Cost of Poor Quality Tool that brings together the available data on these and other costs. It allows you to estimate the costs of quality issues and can be used as a balance to the focus on cycle time. In addition to the Cost of Poor Quality Tool, MCC metrics always include a range of metric types – not just metrics based on time. We recommend implementing more than one metric type to help guard against a sub-optimized outcome.


To submit a question, click here:

Additional Ask the Experts postings are available on the MCC website.
 

Learn More
 

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Education

Is Your Organization Keeping Up with Industry Changes?
Changes in the industry are forcing organizations to do more than just collect and enter data – they have to understand what the data is saying.

To be ICH E6(R2) compliant, organizations need to change the way their trials are conducted and reported, making the need for metric knowledge more important than ever. MCC’s eLearning Education Program is the tool every organization needs to give employees that needed knowledge.

The unique eLearning education program allows professionals to gain a solid metric knowledge foundation with a flexible format that can be customized to meet your needs. The MCC eLearning Education Program:

  • Teaches industry-leading metric understanding
  • Provides a self-study, on-demand learning program to accommodate your busy schedule
  • Accommodates several learning styles
  • Allows you to pause and pick up at a later time
  • Can be easily customized and deployed on your organization’s Learning Management System

Learn more about the entire MCC Education Program and view demos on the following eLearning courses:

MCCe201: The Elements that Make Metrics Effective 

MCCe202: Developing Effective Metrics Using a Structured Process

MCCe203: Effective Metric Visualizations to Gain Valuable Performance Insights


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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

© Copyright 2019 by Metrics Champion Consortium

 
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