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August 2020

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  Important News

Clinical Trial Risk & Performance Management vSummit – Sept. 8-10, 2020
Are you searching for a way to meet industry peers and collaborate on complex clinical trial topics? Hoping to exchange ideas with experts on managing trial risks? Working to dig deeper on performance management with your team? This Metrics Champion Consortium summit is made for you. Industry experts will share how to manage risk in a high-octane environment, assess risk during and after a pandemic, work toward centralized monitoring, decide on a remote or onsite monitoring process, maintain data quality, run risk-based audits, and manage vendors and partnerships. Don’t miss out on this chance to connect with your peers and engage around topics that will change your clinical trial practice for the better. Learn More

MCC’s Clinical Trial Optimization Podcast - New Episodes 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.

EPISODE 2: Turning Insights Into Action: Linda Sullivan and Ken Getz on How Metrics and Benchmarking Provide a Path To Optimizing Clinical Trials Listen Now

EPISODE 3: Get Rid of Those Silos: Linda Sullivan, Artem Andrianov, and Johann Proeve on How To Optimize Clinical Trials through RBQM Listen Now

Subscribe to the podcast show
 

Participation in MCC virtual member community meetings continues to increase – 2020 Q2 registrants exceeded 2K!
A growing number of representatives from MCC member organizations are joining their peers in online meetings hosted by MCC. The first half of 2020 saw a 300% increase in the number of participants compared to the same time period in 2019. Much of the growth can be attributed to the expansion in the number of community of practice/knowledge sharing groups established and supported by MCC. These groups are designed to provide members with a place to share ideas and practical approaches to address challenges unique to these communities.

In Q2 2020, 75% of participants attended knowledge sharing group meetings during which one or more members presented on a topic and/or participated in panel discussions followed by open discussion among all participants. MCC has established six knowledge sharing groups – each group has a unique webpage and knowledge portal. The topics covered in the groups include:

  • Artificial Intelligence / Machine Learning
  • Centralized Monitoring
  • Compliance – CAPA
  • Inspection Readiness - TMF
  • Small Sponsor Community of Practice
  • Study Quality Trailblazers

Additional information about all of the MCC work groups can be found on the MCC website.

These are member-only groups. Registration links are available on the Upcoming Meetings Webpage in the MCC Member Portal. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland.
 

MCC Centralized Monitoring Community of Practice Group Discussed the Challenges of Monitoring a COVID-19 Vaccine Trial
More than 100 registrants joined in the July meeting to hear Esther Huffman O’Keefe and Anne Smith of Regeneron Pharmaceuticals present "Monitoring Covid-19 Studies - A Regeneron Use-Case" case study about the challenges of conducting site monitoring during the pandemic. The presenters shared insights about monitoring an urgent COVID-19 study where few traditional approaches were possible.   “Fit-for-purpose” monitoring was implemented in very tight timelines and with extremely fast data flow. Following the presentation, the group members participated in an extensive discussion about the learnings for future clinical trials, and not just COVID-19 studies.

The session was recorded and is available for MCC members to view – log into the MCC member portal and visit the Centralized Monitoring Community of Practice webpage for details.
 

MCC Adds New, Interactive Whiteboard Functionality to Online Meeting Platform
MCC adds interactive functionality to online meeting platform to enhance collaboration opportunities. With many MCC meetings having increased participation, it can be challenging to get real time input from everyone who wants to provide it. Sometimes, people’s “work” environments are not conducive to speaking up due to background noise (for example, from working at home).  Beginning in July, MCC piloted using annotation functionality at two MCC meetings. Participants had the opportunity to write their ideas on a virtual whiteboard, and to vote on suggestions. On both occasions, participants loved the new interactivity. Feedback received included “this is pretty cool!” and “this is great!” We received many more suggestions than we would normally, and from a much broader range of participants. This new technology will be incorporated into future MCC work group meetings as well as the MCC Virtual Summit in September as we continue to live up to our promise as the place to meet industry peers, exchange ideas, collaborate, and think.


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  Member News

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

MCC newest members are:

  • Calithera Biosciences
  • IQVIA
  • PRA Health Sciences
  • Y-Prime, LLC

MCC thanks the following members for their renewal:

  • BA Fallen Consulting LLC – Betsy Fallen
  • Cripps Clinical Consulting – Martin Cripps
  • Gianni Benzi Pharmacological Research Foundation
  • Gilead Sciences
  • Kyowa Kirin Pharma
  • NYU Langone Health
  • Rho, Inc.

Working group icon

  Featured Work Group

Centralized & Site Monitoring Process Metrics Work Group
MetricsImageHow Do You Measure Repeat Issues?
To date, this work group has developed robust process maps and Key Performance Questions (KPQs) the group wants their metrics to help them answer. At the July meeting, there was a lively discussion on one of the Key Performance Questions as they brainstormed how to use metrics to help answer the KPQ: Are issues being repeated?

While on the surface this sounds like a straightforward thing to measure, your ability to track “repeat” issues is tied to how you categorize issues. Work group members discussed the importance of training people on how the categories are defined and conducting QC to ensure issues are categorized correctly. Additionally, just because two issues are in the same category, it doesn’t necessarily mean that one is a repeat of the other. There is a degree of subjectivity involved in determining if an issue is truly a repeat of a past one which leads to concern that there could be pressure (whether intentional or otherwise) on an individual making the assessment to determine that issues are not repeated making it difficult to identify “repeat issues”. The work group considered other options including an alternative Key Performance Question that might make it easier to develop metrics.

Additional information about the MCC Centralized & Site Monitoring Process Metrics Work Group can be found on the MCC website.

This is a member-only group. Registration links are available on the Upcoming Meetings Webpage in the MCC Member Portal. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland.


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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
Sep 17, 2020
Oct 15, 2020
Nov 19, 2020
eCOA Metrics
3rd Tuesday of the Month at 10AM ET
Sep 15, 2020
Oct 20, 2020
Nov 17, 2020
Site Selection and Start-Up Metrics
1st Tuesday of the Month at 10AM ET
Oct 6, 2020
Nov 3, 2020
Dec 1, 2020

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
Sep 24, 2020
Oct 13, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
Oct 21, 2020
Nov 18, 2020
Compliance & CAPA
2nd Tuesday every other Month at 10AM ET
Sep 16, 2020*
Nov 10, 2020
Inspection Readiness/TMF
Quarterly
Sep 22, 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
TBD
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
TBD
*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.

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
Sep 29, 2020 10AM EDT
Central Lab Metrics
Oct 8, 2020 10AM EDT
Data Management & Biostatistics Metrics
Sep 29, 2020 11AM EDT
Imaging Process Metrics
Oct 7, 2020 11AM EDT
Risk Assessment & Mitigation Management Tool
Sep 30, 2020 11AM EDT
Site Contracting Metrics
Sep 30, 2020 10AM EDT
Vendor Oversight
Oct 7, 2020 10AM EDT
 

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

WCG-MCC Clinical Trial Risk and Performance Management Virtual Summit
Live Sessions 8-10 September 2020 - Access to pre-recorded presentations beginning 26 August

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 accelerated the full implementation of our centralized monitoring program due to the challenges of conducted onsite monitoring visits during the pandemic. Is there a minimum set of site Key Risk Indicators that the MCC recommends?

A: You are not alone in speeding up your implementation! At a recent meeting, we polled participants and found that 50% said that the pandemic increased their organization’s interest in using centralized monitoring and an additional 19% indicated that their organizations are fast tracking implementation and use. 

In terms, of which KRIs to use, MCC members have developed a standard set of Key Risk Indicators that organizations can use as a good starting place. However, this is a fast-moving field – during a recent MCC meeting, we had presentations from a sponsor and vendors on how the challenges of the pandemic have led to them adding new KRIs, such as missed assessment rate, for example. At the MCC Clinical Trial Risk and Performance Management Virtual Summit in September, a virtual Work Group will generate a list of the most commonly used KRIs across the industry, along with their perceived importance and value. The output from that Summit Work Group will be crucial as we review the existing MCC KRIs and publish an update later in the year.

Gold and Platinum Level MCC members are invited to attend the Ask the Expert monthly meetings on the 2nd Friday of each month. We often feature a current issue to discuss, but most of the time is for you to ask questions on topics you are interested in. You also have access to the Ask the Expert Archive Library available in the MCC Member Portal.

To find out your organization’s membership level and more about the Ask the Expert meetings, please email MCC Membership Director, Terry Holland.


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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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