Metrics Champion Consortium
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April 2020

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  Important News

 

MCC Unveils New Forum to Foster Dialogue on Navigating Clinical Trial Operational Challenges Amid COVID-19 Crisis
MCC launched of a new forum designed to spur discourse on the impact of the coronavirus outbreak on clinical trials and how to tackle operational challenges associated with the ever-evolving pandemic. The weekly, virtual series of the MCC COVID-19 Community of Practice connects MCC members, representing more than 80 organizations across the global life sciences ecosystem, and provides them with opportunities to share knowledge and collectively think about how to proactively address common industry concerns around risks to trial integrity and benchmarking study performance amid the COVID-19 crisis.

MCC is leveraging its platform to bring together a diverse, global network of clinical research stakeholders to discuss how they are coping with disruptions to study operations as a result of quarantines, site closures, travel limitations, interruptions in the supply chain for the investigational product and infection of site personnel and trial participants, among other ongoing developments. A document summarizing the topics discussed as well as links to relevant consortium resources and regulatory guidance documents are posted in the consortium’s COVID-19 knowledge portal. 

Weekly COVID-19 Community of Practice discussions will explore top-of-mind questions on virtual patient visits, risk management and control, centralized monitoring, protocol deviations and amendments, and informed consent form amendments, as well as other topics suggested by members. MCC resources, including a web-based knowledge portal and LinkedIn Group, will also be available to members so that they can share challenges, questions and learnings in real time.

To learn more about the MCC COVID-19 virtual discussion group and knowledge portal, please visit https://metricschampion.org/covid-19-knowledge-sharing-group/ or contact MCC.
 

MCC Announces the Release of MCC Imaging Process Metric Toolkit v3.0
The MCC Imaging Process Metric Toolkit v3.0 is now available for MCC member organizations to download from the portal. Thank you to all who provided input and feedback as we carried out this extensive update. The updated metric toolkit includes the following:

  • Updated Metric Definitions
    • Portfolio / Study / Site level metrics
    • Basic / Advanced metric designations
    • Potential Key Risk Indicators
  • New toolkit overview, implementation guide and introductory webinar (13 mins).
  • Updated process map
  • Additional components to assist with your implementation and use of the metrics:
    • Four metric selection tools which help you select the right metrics for your situation and to list the associated data elements needed
    • A metrics reporting planning worksheet to help plan the reporting of the metrics you select

Please visit the MCC Imaging Process Metrics Work Group page for additional information.
 

MCC Relaunching eCOA Process Metric Work Group to Update Metric Toolkit – Join Us on 19 May [Meeting Open to Public]
The use of eCOA methods to collect clinical trial data is rapidly expanding – especially during the COVID-19 pandemic. MCC members have requested that the consortium reconvene the eCOA Metric Work Group to discuss possible updates to the metric set.

Meetings are on the third Tuesday of the month at 11am, starting in May. The first meeting is open to the public.

Tuesday, 19-May-2020 11am EDT      REGISTER NOW [open to public]

  • Review existing MCC eCOA Metrics Toolkit v2.0
  • Developments in eCOA and implications for process metrics
  • Plan for process map and metric updates and next steps
     

Measure the Right Things at the Right Time: Design Key Risk Indicators and Key Performance Indicators that Provide Timely Insights During Study Conduct
MCC released the second paper in a new Measure the Right Things at the Right Time series. This new paper outlines an approach to and rationale for the best way to normalize metrics used as leading indicators to provide early signals of risk, such as with Key Risk Indicators, as part of Risk-Based Quality Management in implementation of ICH E6 (R2). How you define your measurements can allow you to see trends and outliers earlier as well as reduce the number of false positives!  View the paper

The first paper in the series Using A Metric Maturity Model to Optimize Performance Measurement describes a 5-stage metric maturity model that align metrics with process maturity stages. Learn how your organization can realign your metric program to focus on measuring meaningful, high value metrics.  View the paper
 

MCC Artificial Intelligence (AI) – Machine Learning (ML) Knowledge Sharing Group to Meet on 14 April to Discuss How to Design and Implement AI-driven Solutions
The MCC AI/ML Community of Practice – Knowledge Sharing Group was launched in February 2020 to provide MCC members with a place to explore ways to leverage Artificial Intelligence (AI) and Machine Learning (ML) to improve quality and reduce cycle time in clinical trials and help deliver the right drugs to patients who need them. The group meets every other month and has a dedicated LinkedIn Community and a work group webpage/knowledge portal available on the member portal.

During 2020, MCC plans to host six online meetings during which members can participate in heavily interactive presentations led by industry experts. The topics to be discussed will cover the People, Process and Technology aspects of implementing AI/ML and how they apply to process improvement in clinical trials. The 14 April meeting will feature a presentation entitled, “How to design, validate and deploy the AI-driven solution for clinical trials and remain compliant - Dos and Don’ts.” by Artem Andrianov, Ph.D. (CEO and Co-founder, Cyntegrity).

The initial meeting included a presentation entitled, “Artificial Intelligence / Machine Learning in Clinical Research – An Introduction” by Sagar Anisingaraju (Chief Strategy Officer, Saama Technologies) and Malai Sankarasubbu (VP, AI Research, Saama Technologies). A recording of the presentation and subsequent Q&A and discussion (40 minutes) is available to those in MCC member organizations.

To learn more about the MCC AI/ML knowledge sharing group, please visit https://metricschampion.org/artificial-intelligence-ai-machine-learning-ml/ or contact MCC.


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  Member News

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

MCC’s newest members are:

  • Seattle Genetics

MCC thanks the following members for their renewal:

  • ACM Global Laboratories
  • Clinical Pathways, LLC
  • inSeption Group LLC
  • VA Cooperative Studies Program

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  Work Group

MCC Small Sponsor Community of Practice to Discuss Inspection Readiness at a Small Sponsor on 23 April 2020
MCC small sponsor members will gather together in a virtual meeting to discuss Inspection Readiness at a Small Sponsor. The session will begin with a presentation by Donna Dorozinsky, President & CEO, Just In Time GCP followed by a discussion with session attendees.

This MCC virtual group was established to provide small sponsor members with the opportunity to:

  • Share ideas and practical approaches that work in small sponsor settings
  • Get up-to-date news on MCC Performance Metric Sets and Tools
  • Provide feedback about how MCC can support small sponsors
  • Learn from their peers

In addition to bi-monthly online meetings, MCC members can access the Small Sponsor Community of Practice Group Knowledge Portal for self-help resources such as short videos, implementation guides and links to relevant MCC resources. A LinkedIn Group allows sponsors to interact with each other between meetings.

To learn more about the MCC Small Sponsor Community of Practice group, please visit http://metricschampion.org/small-mid-sized-sponsor-community/ or contact MCC.


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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 Process Metrics
3rd Thursday of the Month at 10AM ET
Apr 16, 2020
May 21, 2020
Jun 25, 2020*
eCOA Metrics
3rd Tuesday of the Month at 11AM ET
May 19, 2020
Jun 16, 2020
Jul 15, 2020*
Site Selection and Start-Up Metrics
1st Tuesday of the Month at 10AM ET
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 at 10AM ET
Apr 14, 2020
Jun 9, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
Apr 15, 2020
May 20, 2020
Jun 24, 2020*
Compliance & CAPA
2nd Tuesday every other Month at 11AM ET
May 12, 2020
Jul 14, 2020
COVID-19 Operational Challenges
Every Tuesday at 11AM ET
Apr 14, 2020
Apr 21, 2020
Apr 28, 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
Apr 23, 2020 at 10AM ET**
Jun 15, 2020
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
Apr 21, 2020*
*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.

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

 Metric Set/Toolkit Implementation Q&A
Date & Time
Cardiopulmonary Metrics
Jun 10, 2020 10 AM EDT
Central Lab Metrics
Jun 16, 2020 10 AM EDT
Data Management & Biostatistics Metrics
Jun 10, 2020 11 AM EDT
Imaging Process Metrics
Jun 18, 2020 10 AM EDT
Risk Assessment & Mitigation Management Tool
Jun 17, 2020 10 AM EDT
Site Contracting Metrics
Jun 11, 2020 11 AM EDT
TMF Metrics
Jun 11, 2020 10 AM EDT
Vendor Oversight Finance Metric Toolkit 1.0
Jun 17, 2020 11 AM EDT
 

Connect with MCC at Industry Events 
MCC staff looks forward to having good conversations with you in 2020.

DIA 2020 Global Annual Meeting
June 14-18, 2020
Virtual

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: We are accelerating implementation of our Centralized Monitoring program due to the COVID-19 pandemic. We’ve started with a small number of Key Risk Indicators (KRIs) including AEs/patient. We have upper and lower threshold limits, so we can look for outlier sites – those that are over- or under-reporting relative to others. But what we’ve noticed is that we are getting lots of false signals that are taking time to investigate. For example, a site that has recently been activated and only has enrolled one patient has no AEs/patient and looks like an outlier. Do you have any suggestions for how to set thresholds to take account of this?

A: The Ask-the-Expert article in the March 2020 edition of MCC Metric Insights explored the topic of leading and lagging metrics. With KRIs, you should use leading metrics – metrics that provide information that you can use to course correct on the current study. The problem you describe is not due to the KRI threshold levels – it is the metric that you are tracking. Cumulative AEs/patient is a lagging metric. During the study, as patients progress through their treatment, the likelihood that they will experience AEs increases – in other words, the opportunity for AEs to occur increases. In the example of the site that just enrolled its first patient, there are no AEs reported because the study is just getting started. The leading metric cumulative AEs per patient-week is a better measurement because it accounts for the length of time (number of weeks) each patient has been on the study. Using a version of the measurement that accounts for the time the patient is on the study can significantly impact how early a signal is detected and can help to reduce the number of false signals.

Additional details about defining KRIs are available in the paper we have recently published, Measure the Right Things at the Right Time: Design Key Risk Indicators and Key Performance Indicators that Provide Timely Insights During Study Conduct. We suggest you read the paper and review the definitions of your other KRIs to make sure they are leading metrics too. View the paper


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  Education

MCC’s Learning Institute Helps Improve Clinical Trial Processes and Save Money
Clinical trial performance data can help save millions of dollars in improved processes but only if your people understand how to harness them. MCC’s “Mastering Performance Metrics” eLearning Program helps your key people master performance metrics and eliminate inefficiencies.

Metrics are the key to improving clinical research processes. But without an ability to translate the often overwhelming performance data stream, metrics are useless. Only people can link the numbers to improved processes and “Mastering Performance Metrics” eLearning courses make that link possible.

These courses use fast-paced audio, video and text to accommodate different learning styles — all on your own schedule. Your team members can choose to take one, two or all three courses as appropriate. All three courses allow you to earn ACRP and SOCRA CE credits and prepare you for Metrics Master Certification.

Click HERE to learn more about the entire MCC Learning Institute and on the “Mastering Performance Metrics” eLearning Program:

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

© 2020 Metrics Champion Consortium

 
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