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February 2020

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  Important News

 

Going to SCOPE? Connect with the MCC
Linda Sullivan, MCC Executive Director and Keith Dorricott, MCC Ambassador, look forward to connecting with you during the 11th Annual SCOPE meeting in Orlando February 18-21, 2020. Linda and Keith will be leading track and breakout sessions on Risk-Based Monitoring, Vendor Oversight, and Vendor Performance Metrics and KPIs.

Linda will give the chairperson’s remarks on Risk-Based Quality Management Strategy on February 19 before co-presenting Bridging the Gap Between Issue Management and Risk-based Quality Management with Ann McCabe, Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc. Both sessions fall under the Implementing Risk-Based Monitoring Track (Part 1).

Keith will lead an interactive breakout discussion with Caro Unger, Senior Clinical Operations Standards and Innovation Manager, Clovis Oncology, on February 19. He will be at Table 22 discussing Vendor Performance Metrics and KPIs.

Keith will also lead a presentation on Vendor Oversight: Metrics, KPIs and ICH E6(R2) on February 21, This session falls under the Managing Outsourced Clinical Trials track.

If you would like to schedule a time to meet with Linda and Keith during SCOPE, please contact MCC Membership Director Terry Holland at tholland@metricschampion.org who will assist you in setting up a meeting.

Learn more about Linda and Keith’s sessions.
 

MCC Launches New Compliance & CAPA Community of Practice Group; First Meeting OPEN TO THE PUBLIC
MCC is pleased to announce the addition of a new Community of Practice (CoP) for Compliance & CAPA professionals. The first meeting on March 10, 2020 at 11 AM is open to both MCC members and non-members. MCC CoPs are about members helping members. MCC hosts these online meetings and associated LinkedIn Groups for member to learn from each other by sharing case studies, discussing challenges and developing possible solutions. The online meetings will be every two months with topics chosen by the members of the work group.

The topic for the Compliance & CAPA launch meeting will be “Effective Root Cause Analysis” lead by Sandra SAM Sather, Vice President at Clinical Pathways, and Dawn Niccum, Senior Director, QA & Compliance at inSeption Group.

Subsequent meetings will be open to MCC member organizations only. Topics will include:

  • Categorization of issue / findings and trending
  • Effectiveness Checks – theory and practice

The CoP will focus on the challenges and opportunities for compliance and CAPA processes discussing a range of topics led by members.

Each CoP meeting will include a presentation and opportunity for discussion and Q&A. Anyone from MCC member organizations can attend any of the Community of Practice meetings – just to listen, to discuss, or even to present on a topic.

Register now for the March 10 meeting.
 

MCC Releases the Vendor Oversight Finance Metric Toolkit 1.0
The Vendor Oversight Metric Development Work Group has launched its Finance Metrics Toolkit 1.0 that includes robust metric definitions for sixteen metrics and additional components to assist with metric selection, implementation and use.

The finance metrics are defined at four different levels; Portfolio, Study, Country and Investigative Site, and have clarity on purpose, definition, target and use.

The components of the toolkit are:

  • Metric Toolkit Overview and Implementation Guide
  • Metric Toolkit Overview (recorded webinar)
  • Metric Workbook

Metric Selection & Implementation Support Tools include:

  • Key Performance Questions to metrics
  • Issues to metrics
  • Basic/Advanced metrics to data elements
  • Data elements to metrics
  • Metrics reporting planning worksheet

MCC members can access the Finance Metrics Toolkit 1.0, by logging into the MCC member portal and selecting “Existing Metric Set” and scrolling down to “Portfolio Management.”

This release concludes the work of the Vendor Oversight Metric Development Work Group. The many accomplishments of the work group include:

  • Four metric toolkits
  • Detailed definitions of 59 metrics – developed using the MCC Metrics Development Framework
  • 28 glossary terms defined
  • Detailed guidance on relationship surveys published
  • Agreement on different approaches to aggregation of data across studies
  • 225 individuals registered to meetings representing 56 companies

The work group now moves into the metric implementation phase and no further metrics will be developed during this phase. Beginning in June, there will be quarterly Implementation Q&A meetings for Vendor oversight.

The first Implementation Q&A will be June 17, 2020 at 11AM EDT. Participants will review the metrics across all four sets for vendor oversight – timeliness, quality, finance, and relationship and have an opportunity to raise questions, discuss challenges, make suggestions on implementation. MCC members can register for this meeting by logging into the member portal, clicking the Members & Work Groups tab and scrolling down to Vendor Oversight under the Metrics Development Tab.
 

MCC eCOA Metrics Development Work Group to Relaunch – Join Today to Participate!
eCOA technology is fast changing and the processes surrounding its use continues to develop. MCC member organizations have identified additional areas where we need to expand our existing metrics set and so we will be relaunching this work group to review the existing metrics and determine options for expansion.

Are you interested in finding out more? Contact MCC Membership Director, Terry Holland to register your interest.
 

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2020 MCC Clinical Trial Risk and Performance Management Summit – Call for Abstracts.
Is your organization interested in sharing a case study about using MCC metrics and/or quality tools?

Contact Linda Sullivan, MCC Executive Director, or Keith Dorricott, MCC Ambassador, to learn how your organization can be a part of the 2020 MCC Clinical Trial Risk and Performance Management Summit.

The 2020 Summit will be September 9-10 in Philadelphia. The 2019 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. Contact Linda or Keith 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.
 


Member news icon

  Member News

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

MCC’s newest members are:

  • Catalyst Clinical Research

MCC thanks the following members for their renewal:

  • Janssen/Johnson & Johnson
  • Mallinckrodt
  • MedQIA
  • Medtronic
  • Oracle
  • Triumph Research Intelligence

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  Work Group

MCC Site Selection and Start Up Work Group Discuss Differences Between Leading and Lagging Metrics
While examining three primary Key Performance Questions (KPQs), the Site Selection and Start Up Work Group discussed approaches to develop leading and lagging metrics.

For the first two KPQs – Have we identified the PIs/Sites that are going to qualify, activate and enroll the fastest? and, Have we identified the PIs/Sites that are going to provide high quality data? – the work group talked about approaches to develop leading as well as lagging metrics.

Lagging metrics can be used for planning future trials but leading metrics are also needed that can be used to course correct during a trial. This led to a discussion of metadata needed for metrics as well as predictive analytics. The work group will consider developing metrics that might be predictive of performance, gathering them over time and including them in data analysis to provide evidence of whether they are predictive.

The next meeting for the Site Selection and Start Up Work Group will be on March 3, 2020 at 11AM EST. MCC members can register by visiting the Site Selection and Start Up Work Group page on the MCC member website or contacting Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.


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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
Feb 27, 2020* 11AM EST**
Mar 19, 2020
Apr 16, 2020
May 21, 2020
Jun 25, 2020*
Imaging Performance
3rd Tuesday of the Month 10AM EST
Feb 25. 2020* 11AM EST**
Site Selection and Start-Up Metrics
1st Tuesday of the Month 10AM EST
Mar 3, 2020 11AM EST**
Apr 7, 2020
May 5, 2020
Jun 2, 2020
*Meeting date deviates from regularly scheduled frequency.
**Meeting time deviates from regularly scheduled frequency.
 

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 10AM EST
Apr 14, 2020
Jun 9, 2020
Centralized Monitoring
3rd Wednesday of the Month 10AM EST
Mar 18, 2020
Apr 15, 2020
May 20, 2020
Jun 24, 2020*
Compliance & CAPA Process Metrics
2nd Tuesday Every Other Month 11AM EST
Mar 10, 2020
May 12, 2020
Jul 14, 2020
Small Sponsor Community
of Practice
Every Other Month 11AM EST
Feb 11, 2020
*Meeting date 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 12 PM EDT**
Compliance & CAPA Process Metrics
TBD
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Mar 10, 2020 10 AM EDT
eCOA Metric Toolkit v2.0
TBD
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 12 PM EDT**
Vendor Oversight Finance Metric Toolkit 1.0
Jun 17, 2020 11 AM EDT
**Meeting time deviates from regularly scheduled frequency.

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 at Industry Events 
MCC staff looks forward to having good conversations with you in 2020. Please let us know if you are interested in scheduling a one-on-one meeting at any of the following events.

SCOPE
February 18-21, 2020
Orlando, FL

Track: Implementing Risk-Based Monitoring – Part 1
Date: February 19, 2020
Session Title: “Risk-based Quality Management Strategy”
Session Participants: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium and Ann McCabe, Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.

Interactive Breakout Discussions
Date: February 19, 4:20-5:10 PM
TABLE 22: Vendor Performance Metrics and KPIs

  • How effective are your KPIs for measuring vendor performance and quality?
  • What is your strategy for establishing KPIs and metrics?
  • What are the key areas that should be evaluated for vendor performance and quality?

Moderators: Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd., and Caro Unger, Senior Clinical Operations Standards and Innovation Manager, Clovis Oncology

Track: Managing Outsourced Clinical Trials
Date: February 21, 2020
Session Title: Vendor Oversight: Metrics, KPIs and ICH E6 R2
Session Participant: Keith Dorricott, Ambassador, WCG-Metrics Champion Consortium

Learn More

Clinical Trial Innovation Summit
April 6-8, 2020
Cambridge, MA

Track: Risk-based Monitoring
Presentation: “Is Your Centralized/Onsite Site Monitoring Program Being Implemented per ICH E6(R2)? How Do You Know?”
Session Participant: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Roundtable Discussion: “Implementation of Clinical Development Risk Management”
Session Participants: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium and Jonathan Rowe, Pfizer

Learn More 

DIA 2020 Global Annual Meeting
June 14-18, 2020
Washington, D.C.

Track: 02 Clinical Trials and Clinical Operations
Presentation: “Management of Centralized, Remote, and Site Monitoring Models Using Metrics to Improve Process and Oversight”
Session Participant: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Learn More

MCC Clinical Trial Risk and Performance Management Summit
Sept 9-10, 2020
Philadelphia, PA

Please contact MCC Executive Director 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 panelist.

Learn More


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  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: At a recent MCC meeting, there was discussion about the differences between leading and lagging metrics. I can see why leading metrics could be very useful but why would anyone be interested in lagging metrics?

A: This discussion took place at the Site Selection and Start-Up Process Metrics Work Group. There is a video summary of the discussion available to those in MCC member organizations on the LinkedIn Community and the MCC member portal. The group was discussing how to assess whether we identified sites that are going to activate and enroll the fastest as well as provide high quality data. Metrics can be used to assess this once all data has been received (i.e. Database Lock) but that’s too late to modify the site identification and selection for that particular study. These measurements are lagging metrics. Lagging metrics can’t help you to course correct for the current study but they can be used to understand how the process is performing currently compared with desired performance. They can be used to monitor how well the process is working over time. And they can be used for planning purposes for future studies. Examples of lagging indicators are:

  • Time taken to select all sites
  • Time taken to enroll all patients
  • Percent of sites that enroll one or fewer patients

These would all be useful data to have to understand how the existing processes are performing and for planning purposes.

Leading metrics, on the other hand, provide information that you can use to course correct on the current study (or program). Leading metrics are the type of metrics used as Key Risk Indicators in Centralized Monitoring – to indicate increased risk so that actions can be taken to avoid issues, or to minimize their impact. Examples of leading indicators are:

  • Percent of patients enrolled vs. plan
  • Percent of sites activated vs plan
  • Protocol deviations per patient-week

To use an analogy of a car – the dashboard provides leading metrics such as speed and gas level that drivers uses to modify their driving as necessary. Metrics such as fuel consumption rate are lagging but do provide useful information that can be used for planning purposes and perhaps to consider options to improve over time. Both leading and lagging metrics have their uses.

Later this month, the MCC will be publish a guidance document on the best way to define leading metrics that will be available free to those from MCC member organizations.


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  Education

Unlock the Power of Your Data to Dramatically Improve Clinical Research Efficiency
Organizations have to do more than just collect data – they have to understand what the data is saying. MCC’s eLearning Institute 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 Institute:

  • Teaches industry-leading metric understanding and risk management concepts
  • 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 on the following eLearning courses:

MCC e201: The Elements that Make Metrics Effective

MCC e202: Developing Effective Metrics Using a Structured Process

MCC e203: Effective Metric Visualizations to Gain Valuable Performance Insights

MCC e204: MCC Metric Master Certification Independent Project

MCC e301: Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management


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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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