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November 2020

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  Important News

MCC Clinical Trial Optimization Podcast – New Episode Available!
PhoneTestImage The 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. For more information about the podcast and to view a full listing of show episodes please click here.

EPISODE 9 – Implementing the Successful Total Cost of Quality Model in Clinical Trials: Yes, You Can — and Must — Eliminate Waste with Linda Sullivan and Keith Dorricott Listen Now

Subscribe today! Apple PodcastsSpotifyStitcherAndroid

Why are QTLs so Difficult to Implement? MCC Panel Discussion on 18 November to Kick-off QTL Exploration
During the MCC Clinical Trial Risk and Performance Management Virtual Summit, a Working Group developed a list of commonly used Quality Tolerance Limit (QTL) parameters and discussed implementation challenges. Summit Working Group participants asked MCC to continue to help the industry develop a practical approach to QTL implementation and use. The 18 November Centralized Monitoring CoP meeting will feature a panel session and open discussion about industry challenges with QTL implementation.

Topic: “Panel Discussion – Industry Challenges with QTL Implementation”

  • Artem Andrianov, CEO, Cyntegrity
  • Margaret Kutozova, Associate Director, Project Management Centre of Excellence, IQVIA
  • Leslie Sam, Principal Consultant, Wool Consulting Group
  • Michael Walega, Head of Centralized Monitoring, BMS
  • Steve Young, Chief Scientific Officer, CluePoints

The panel will discuss why, four years since adoption of ICH E6 (R2), QTL implementation continues to be such a challenge for organizations. How should you determine QTL parameters and thresholds? When might a deviation count as not being important (and therefore require reporting in the CSR)? What can we do to help organizations implement and use QTLs?

MCC is forming a sub-team of Subject Matter Experts to develop materials to assist organizations with implementation and use of QTLs. Some of the questions sub-team members will discuss include:

  • Allowance for study-level KRIs (and general study-level risk and operational/performance monitoring) separate from QTLs
  • What constitutes an "important breach" to a QTL (i.e., those that require reporting in CSR)?
  • Leading QTL Indicators and proper normalization
  • How/where should QTLs be identified for a study (e.g., pre-study risk planning, QBD risk review, both, other)?
  • When should QTLs be based on historical data/benchmarks, and when should they be based on "statistical characteristics of variables" (ICH E6 R2 language)? 

The sub-team will develop a QTL toolkit to assist organizations in implementation. We are looking for cross-industry representation from sponsors, CROs, vendors and others. Anyone from an MCC member organization is welcome to participate in the discussions.
Learn More

Are You Measuring the Right Things to Improve Start-Up Timelines? MCC Site Selection & Start-Up Process Metrics Work Group to Discuss Ethical Review Metrics on 1 December
The MCC Site Selection & Start-Up Process Metrics Work Group will meet on 1 December 2020 at 10 am ET to discuss how to measure ethical review processes and opportunities to reduce timelines. Industry expert Tim Schuckman, Chief Commercial Officer, Ethical Review at WCG will share insights in the following presentation:

Ethical Review – Are you measuring the right things to improve your start-up timelines

  • Discussion on effectively and accurately measuring cycle time
  • How partnership with IRBs can lead to greater efficiency

Following the presentation, Tim will engage with work group members to discuss the most important ethical review key performance questions and metrics to include in the MCC Site Selection & Start-up metric toolkit.
Learn More

MCC Members Have Opportunities to Share Knowledge at Upcoming Online Meetings

 Work Group
Topic
Date
Audit, Compliance & CAPA CoP
“Effectiveness Checks for CAPAs – why are they so difficult to get right?”
12-Jan-2021
11-12pm EST
Centralized Monitoring CoP
“Panel Discussion – Industry Challenges with QTL Implementation”
18-Nov-2020
10-11am EST
Centralized & Site Monitoring Process Metrics
“Can we define and measure False Positives, False Negatives and possible metrics as part of an assessment of KRI effectiveness?”
19-Nov-2020
10-11am EST
eCOA Process Metrics
We will continue our in-depth review of Key Performance Questions and metrics with a focus on issues with the eCOA Application/Database and data queries.
17-Nov-2020
10-11am EST
Inspection Readiness/TMF CoP
“Tools for preparing and for hosting a remote inspection”
08-Dec-2020
10-11am EST
Site Selection & Start-up Metrics
We will continue our focus on the ethics/IRB submission and approval process – the Key Performance Questions we want our metrics to answer, and possible metrics.
1-Dec-2020
10-11am EST

Member news icon

  Member News

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

MCC newest members are:

  • Arena Pharmaceuticals
  • Astex Pharmaceuticals
  • Otsuka America (OAI & OPDC)
  • Sanofi

MCC thanks the following members for their renewal:

  • Abbott
  • Bluebird Bio
  • Bristol-Myers Squibb
  • H3 Biomedicine, Inc.
  • INOVIO Pharmaceuticals
  • Wool Consulting Group Inc.

Working group icon

  Featured Work Group

Centralized and Site Monitoring Process Metrics Work Group
MetricsImageHow Frequently do KRIs That Breach Thresholds Signal Actual Issues?

During the virtual meeting on 19 November, the group will continue with the discussion started at the last meeting about KRI threshold breaches (risks) that are “false” or not representative of actual issues. These are sometimes termed “false positives”. An MCC member organization will share data collated across sponsors/CROs on the proportion of sites where KRIs indicate a risk for commonly used KRIs. And of those, the proportion that are subsequently determined to be true issues. The group will consider whether a metric related to this might help answer the Key Performance Question “Is Centralized Monitoring adding value?”
Learn More


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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 11AM ET
Nov 19, 2020at 10AM*
Jan 21, 2021
Feb 18, 2021
eCOA Process Metrics
3rd Tuesday of the Month at 11AM ET
Nov 17, 2020 at 10AM*
Jan 19, 2021
Feb 16, 2021
Site Selection and Study Start-Up Metrics
1st Tuesday of the Month at 11AM ET
Dec 1, 2020 at 10AM*
Jan 13, 2021
Feb 2, 2021
*Deviates from regularly scheduled day or time.

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 11AM ET
TBD
Audit, Compliance & CAPA
2nd Tuesday every other Month at 11AM ET
Jan 12, 2021
Mar 9, 2021
May 11, 2021
Centralized Monitoring
3rd Wednesday of the Month at 11AM ET
Nov 18, 2020 at 10AM*
Jan 20, 2021
Feb 17, 2021
Consultancy
Once per Quarter
 
Inspection Readiness/TMF
Quarterly
Dec 8 2020 at 10AM*
Feb 9, 2021
Apr 13, 2021
Small Sponsor Community
of Practice
Every other Month at 11AM ET
TBD
Study Quality Trailblazer
2nd Wednesday of the Month at 11AM ET
TBD
*Deviates from regularly scheduled day or time.
 

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
Jan 26, 2021 11AM EST
Central Lab Metrics
Jan 27, 2021 11AM EST
Data Management & Biostatistics Metrics
Jan 26, 2021 10AM EST
Imaging Process Metrics
Jan 27, 2021 10AM EST
Risk Assessment & Mitigation Management Tool
Jan 28, 2021 10AM EST
Site Contracting Metrics
Jan 28, 2021 11AM EST
Vendor Oversight
Jan 20, 2021 11AM EST
 

Connect with MCC at Industry Events 
MCC staff looks forward to having good conversations with you in 2021.

WCG-MCC Clinical Trial Risk and Performance Management Virtual Summit
See you September 2021


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 are trending our audit and inspection finding data to help us focus on areas of risk. But when audits and inspections halted in Q2, due to the pandemic, our trending showed an improvement across the board. This was clearly a false signal. How do you recommend we tackle this?

A: The MCC Centralized and Site Monitoring Process Metrics Work Group has been discussing how to use audit and inspection data to provide insights into whether issues have been detected and appropriately remediated. The challenge you’re raising is that trending the number of issues over time can be misleading because the opportunity to detect those issues varies over time – and the pandemic has brought this into sharp focus. In addition to reviewing the trending of audit findings, you should add a metric that normalizes the issue counts to take into account the opportunity of detection. For example, if there are 10 site audits with findings related to Principal Investigator oversight, and only 10 site audits were conducted, that’s indicating a systemic issue – the issue was found on 100% of the opportunities. Whereas, if there were 100 site audits, for which 10 had findings related to Principal Investigator oversight, this indicates the issue is not so prevalent – i.e. the issue was found on 10% of the opportunities. So, a measure of prevalence of findings, trended over time, might provide a better guide. In addition to looking at overall prevalence, you might consider looking at prevalence of issues by issue type. This requires clearly defined categories for issue types – a MCC group is developing a categorization framework for organizations to utilize in the future.


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  Education

WCG Metrics Champion Consortium Expands Its Learning Institute with New eLearning Courses
Addition of Clinical Pathway’s On-Demand, Performance Management and Good Clinical Practice Training Courses Enriches Resources Available to MCC Members

MCC now offers 12 new eLearning courses on performance management and good clinical practice (GCP) developed by Clinical Pathways, LLC to provide stakeholders across the clinical research community with high-quality, effective training resources.
Learn More


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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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