Metrics Champion Consortium
MetricInsights

Twitter  LinkedIn

October 2020

News icon

  Important News

MCC Clinical Trial Optimization Podcast – 2 New Episodes 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 7 – Optimizing Human Performance in Clinical Trials by Applying Gilbert’s Behavioral Engineer Model with Linda Sullivan and SAM Sather Listen Now

EPISODE 8 - Implementing Successful RBQM Programs Requires Three-Pronged Approach – It’s Not Just Software Implementation, with Linda Sullivan and Gary Tyson Listen Now

Subscribe today! Apple PodcastsSpotifyStitcherAndroid

MCC Members Get a Rare Glimpse into How “Machines Learn” During Case Study Presentation and Live System Demo in the Artificial Intelligence / Machine Learning Community of Practice Meeting
During the AI/ML meeting on 24 September, Ashley Howard (Associate Director, Asset Lead, Pfizer) and Sagar Anisingaraju (Chief Strategy Officer, Saama Technologies) presented a case study entitled, Intelligent Machines Take on Clinical Data Management. As described in the presentation, the objective of the Smart Data Query System is to automate data query management using machine learning to predict discrepancies, reason for the discrepancies and auto-generate query text to be sent to sites. The presentation laid out the steps involved with training the machine by repeating “teach cycles” that provide “ground truth” to recognize data patterns. At the end of each teach cycle, humans review the machine’s predictions and provide feedback about the following:

  • Was it a data discrepancy?
  • Was the right subcategory of the data discrepancy identified?
  • Was the suggested query text acceptable?

Following the presentation, Ashley demonstrated the Smart Data Query Platform that Pfizer is using to assist Clinical Data Managers with the manual query process. There was much interest in the demonstration and lots of questions and discussions. At the end of the online session, one participant thanked the presenters for sharing their knowledge and praised MCC for providing a place where the industry can come together to discuss important topics. The September meeting is available to play back for those in MCC member organizations.

MCC members are invited to register for the next meeting on October 13th during which Elvin Thalund (Director, Industry Strategy, Oracle Health Sciences) will present a case study on using machine learning to predict site start-up times. Registration links are available on the Meetings & Work Groups 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.

Centralized Monitoring Community of Practice Forming Sub-Team to Explore Quality Tolerance Limit Implementation Challenges
The 18 November Centralized Monitoring CoP meeting will feature a panel session and open discussion about Industry Challenges with QTL Implementation. 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.

Following the November CoP meeting, MCC staff will work with a sub-team of the Centralized Monitoring CoP members interested in exploring this topic in detail. 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.

Audit, Compliance & CAPA Community of Practice Developing Issue Categorization Framework
During the 12 November Audit, Compliance & CAPA Community of Practice meeting, participants will continue to explore the topic of issue categorization with a presentation “The Importance and Challenges of Determining Issue Severity” by Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences. Oleg will discuss some of the challenges – in particular with different regulations and guidance around the world. Following the presentation, participants will have the opportunity to ask questions, share ideas and discuss challenges. Oleg’s presentation builds on concepts discussed at the September meeting when MCC Ambassador Keith Dorricott introduced the topic in a presentation entitled, “Should we categorize issues by type or by root cause?” Following Keith’s presentation, CoP members discussed the value and challenges of issue categorization. A summary recap video of the September meeting is posted on the CoP webpage in the member portal.

At the conclusion of the September meeting, CoP members decided to establish a sub-team to develop a categorization system based on issue/risk type and root cause. If you’re interested in joining the sub-team, please contact Keith at kdorricott@metricschampion.org for details.

MCC Members Have Opportunities to Share Knowledge at Upcoming Online Meetings

 Work Group
Topic
Date
Audit, Compliance & CAPA CoP
“The Importance and Challenges of Determining Issue Severity?”
Oleg Shevaldyshev, PRA Health Sciences
12-Nov-2020
10-11am EST
Centralized Monitoring CoP
"Listen Hard, Adapt Quickly and Prioritize Ruthlessly a case study in RBM implementation on Pfizer’s COVID-19 Vaccine trial"
Crupa Kurien, Pfizer, Phi Tat, Pfizer; Jennifer Campbell, CluePoints
21-Oct-2020
10-11am EDT
Centralized & Site Monitoring Process Metrics
“Review Proposed Metrics for Site Issue/Risk Management/Focus on Site Monitoring Set-Up”
15-Oct-2020
10-11am EDT
eCOA Process Metrics
What Matters in the eCOA Process?
20-Oct-2020
10-11am EDT
Inspection Readiness/TMF CoP
Tools for Preparing and Hosting Remote Inspections – A Discussion
08-Dec-2020
10-11am EST
Site Selection & Start-up Metrics
Review proposed definitions for metrics in the screening/enrollment part of the process then move to metrics on regulatory and ethics submission and approval
3-Nov-2020
10-11am EST
Study Quality Trailblazer Group
Protocol Operational Complexity Scoring Tool – proposed updates
9-Dec-2020
10-11am EST

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.
 


Member news icon

  Member News

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

MCC newest members are:

  • Medidata Solutions
  • Spectral Medical, Inc.

MCC thanks the following members for their renewal:

  • Driftpin Consultants - Kevin Shea
  • Myokardia
  • PM Clinical Consulting Ltd. – Peter Marks

Working group icon

  Featured Work Group

Centralized Monitoring Community of Practice Group
COVID-19 Case Study: “Listen Hard, Adapt Quickly and Prioritize Ruthlessly: a case study in implementing Centralized Monitoring on Pfizer’s COVID-19 Vaccine trial”

The Centralized Monitoring CoP continues with record registration and thought-provoking discussions. During the 21 October meeting, Crupa Kurien (Senior Associate, Central Monitoring, Pfizer), Phi Tat (Manager, Central Monitoring, Pfizer), Jennifer Campbell (Data Analyst, CluePoints) will present a centralized monitoring implementation case study on Pfizer’s COVID-19 vaccine trial. This case study continues the group’s discussion about monitoring COVID-19 studies which began during the July meeting during which representatives from Regeneron discussed how they radically changed their approach to monitoring for a COVID-19 study with extremely tight timelines. The July meeting is available to play back for those in MCC member organizations – log into the MCC member portal and visit the Centralized Monitoring Community of Practice Knowledge Portal.


Calendar icon

  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
Oct 15, 2020
Nov 19, 2020
eCOA Process Metrics
3rd Tuesday of the Month at 10AM ET
Oct 20, 2020
Nov 17, 2020
Site Selection and Study Start-Up Metrics
1st Tuesday of the Month at 10AM ET
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
Oct 13, 2020
Audit, Compliance & CAPA
2nd Tuesday every other Month at 10AM ET
Nov 12, 2020
Jan 12, 2021
Centralized Monitoring
3rd Wednesday of the Month at 10 AM ET
Oct 21, 2020
Nov 18, 2020
Inspection Readiness/TMF
Quarterly
Dec 8 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
TBD
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
Dec 9, 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.

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 2020.

MCC to Present at SCOPE Summit Europe & Clinical Trial Innovation Summit 2020 Virtual Event
“Critical Data and Processes: How ICHE6(R2) Is Changing Vendor Management and the Data Sponsors Are Reviewing during Clinical Studies”
Linda Sullivan, MBA, Executive Director, WCG-Metrics Champion Consortium

ICH E6 (R2) addendum highlights the importance of focusing resources on managing critical processes and data, as well as a sponsor’s obligation to ensure oversight of trial-related duties and functions carried out on its behalf. As organizations update their processes to include early identification and oversight of critical processes and data, they are increasing the level of scrutiny of services provided by CROs and other vendors, such as central labs, eCOA, ECG core labs, and imaging core labs. During this session, Linda will review:

  • Sponsor requirements to ensure oversight of CROs and other vendors, as well as vendors contracted by CROs on the sponsor’s behalf
  • How to determine which vendors perform critical processes and provide critical data
  • What performance data reported by CROs and/or other vendors allow sponsors to actively manage risks and reduce the likelihood of severe consequence?

“How Can Cost of Quality Help Us Implement Quality by Design (ICH E8 R1)?”
Keith Dorricott, Ambassador, Metrics Champion Consortium

The concept of quality by design has been around for a number of years in clinical trials. By building quality into the protocol design and trial operations from the start, overall quality is improved, and costs should be reduced. But, there are challenges to implementation – the desire to get to "First Patient In" as soon as possible, and the lack of measurement of the costs when things go wrong due to poor design and planning. In this presentation, we explore the concepts of quality by design in ICH E8 (R1) and the cost of quality. We will look at a tool developed by an industry consortium to help assess the cost of poor quality to help with decision making for quality by design.

For more information on MCC participation at the event click here.

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: [Asked at the live MCC Risk Assessment & Mitigation Tool Q&A meeting on 30 September 2020]  Who should be involved in the risk assessment? There is a lot to cover and having everyone in one meeting might not be the most efficient way to involve every function.  What is your experience and what the best of practice would be suggested?

A: [Based on MCC experience and responses at the meeting] You are absolutely right that there are many different perspectives that it would be valuable to bring into a risk assessment. Not only the functional perspective but also the perspective of vendors (e.g. CROs) and the sites performing the study. Having all representatives in one long meeting may not be the best use of everyone’s time – but this has to be weighed up against the value of those present building off each other’s’ ideas. With cross-functional representation, mitigations are likely to be improved too – for example, Site Monitoring may be able to carry out additional checks to monitor a particular risk but Data Management may have an automated approach that would be more effective. There are ways to streamline the risk assessment though and preparation is key. Those attending the meeting should understand the basic steps of the risk assessment including starting with critical data and processes, risk statements and scoring based on Likelihood, Impact and Detectability. Some organizations ask attendees to develop risk statements to bring to the meeting ready for discussion. Others have a trained facilitator who meets individually with each function to develop risk statements that can then be collated and sent round for review prior to the main meeting. It is unlikely that everything can be covered in one meeting and having one meeting to focus on the risk assessment (through to prioritizing risks) and another to focus on developing mitigations for risks which need to be reduced is a common approach.


Education icon

  Education

Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals eLearning Course - Now Available!
Sponsors, CROs, and research sites are required by regulatory authorities and GCP to have an effective process to manage significant noncompliance through corrective and preventive action (CAPA) plans. These stakeholders should have procedures to support their CAPA system and documentation. Team members must understand a CAPA process and how it links into quality risk management. This training is designed to provide this understanding and is an essential companion to training on a company specific CAPA system. It is also a foundation for the CAPA process and supports understanding through GCP industry specific case scenarios and other application exercises in each section. Learn more


Join icon

  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.

1f6751a2-5be3-491c-856c-cf2d51c4a008.gif

Join the MCC LinkedIn Group to learn about industry performance metrics and stay informed of new developments.

 
WCG MCC Logo

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

 
Untitled Document