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September 2019

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  Important News

MCC 2019 Risk and Performance Management Summit Rated “Best in Class” by Participants
MCCSummtPic3 More than 100 North American and European-based individuals from large and small biopharma, CROs, risk-based monitoring and consulting organizations participated in the 2019 MCC Risk and Performance Management Summit in Philadelphia on September 4-5. This year, the Summit focused on five themes.

Those themes were:

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  • Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution: Keynote speaker Kenneth Getz, Director of Sponsored Programs and Associate Professor, Tufts University; Founder and Board Chair, CISCRP, shared insights about the state of the drug development industry and the need for and impact of patient engagement approaches.
  • Metric Program Implementation: Practical approaches and lessons learned from industry veterans.
  • Risk-based Quality Management: Emerging practices in the adoption of risk-based quality management, including the impact of ICH-E6(R2) updates, risk management for small sponsors, quality tolerance limits, developing and using key risk indicator libraries and the application of artificial intelligence, and machine learning.
  • Risk-based Vendor Oversight: The impact of ICH E6(R2) on vendor oversight, key considerations to developing healthy sponsor/vendor engagement, and using metrics to manage vendor risk and performance.
  • Applying Critical Thinking Skills to Utilize Metrics Effectively: Participants worked in teams to uncover the root cause(s) of issues described in a case study. Each team was provided with a case study packet that included a description of the organization and outsourcing vendors, protocol synopsis, data reports and questions to explore. Teams were able to request additional metric reports and other types of information to help them determine whether there were issues that needed to be addressed.

MCCSummtPic1The Summit format of presentations, panel discussions, audience polling, facilitated breakout group discussions and small group exercises encouraged active participation of all attendees, and fostered the sharing of ideas and collaborative discussions.

“I am pleased that we continue to provide the industry with a safe place for people to learn, meet peers and share ideas. We received very positive feedback from participants confirming that the Summit is a unique experience and the importance of continuing to run the event in the future,” said MCC Executive Director, Linda Sullivan, who added that many participants plan on bringing colleagues to the 2020 Summit. “We are already exploring the feasibility of starting several new MCC online, interactive groups to provide MCC members with a forum to continue to explore several popular breakout group topics!”

MCCSummtPic2Risk-based Monitoring Track Chair, Keith Dorricott said they had some great exchanges of views and ideas among true thought leaders in the industry. “There was a high level of energy in the room. I found the discussion on use of Artificial Intelligence eye-opening as senior leaders were quoted as expecting critical thinking skills would no longer be in as much need and yet delegates all thought more critical thinking skills will be needed,” said Keith.

MCC is planning to host the MCC Clinical Trial and Performance Management Summit in September 2020. Please contact MCC Executive Director Linda Sullivan or MCC Ambassador Keith Dorricott if there are topics you would like to see included and whether you are interested in participating as a presenter of panellist.
 

MetricsImageHow Should You Measure and Assess New Centralized/Remote/Onsite Site Monitoring Programs?
Adoption of ICH E6(R2) Risk-Based Quality Management approaches has brought significant changes to site monitoring processes. The processes have changed. How do you evaluate and manage these new monitoring approaches? Do metrics used to oversee “traditional” site monitoring processes still apply? The industry needs to come together to develop a new set of standardized metrics that align with the new emerging approaches of risk-based site monitoring.

MCC is launching a new work group to develop a comprehensive set of performance metrics in this important area. During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.

BlueTakeSurvey
CLICK HERE to complete the survey by October 10, 2019.

 

Come and join us!

The MCC work group will convene for an online meeting on October 17, 2019 at 10AM EDT. During the meeting, we will review survey results and discuss the following aspects related to the process of centralized, remote and site monitoring:

  • What does the high-level process look like?
  • What are the process issues organizations are encountering?
  • What are the important questions that we want metrics to help us answer?

GreenRegister
REGISTER NOW

Open to public

 

CLICK HERE For additional information about this new work group.
 

SiteSelectionImageHow Does Your Site Selection and Start-up Process Compare to Your Peers? Where Are Your Opportunities to Improve the Process?
MCC is launching a metric development work group to define site selection and site study start-up process metrics. In 2018, MCC released the MCC Site Contracting Metric Toolkit v1.0 that includes detailed metric descriptions and Global Start-Up Comparison Models that group countries into five models according to the impact that local regulatory and ethic approval processes have on the site contracting process.

This new MCC work group will build upon the foundation established in the site contracting toolkit and examine the overall process of site selection and start-up. Our goal is to collaboratively develop standardized metrics that can be used across the industry to monitor, manage and improve the process.

During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.

BlueTakeSurvey
CLICK HERE
to complete the survey by September 25, 2019.

 

Come and join us!

The MCC work group will convene for an online meeting on October 1, 2019 at 10AM EDT. During the meeting, we will review survey results and discuss the following aspects related to the process of site selection and study start-up:

  • What does the high-level process look like?
  • What are the process issues organizations are encountering?
  • What are the important questions that we want metrics to help us answer?

GreenRegister
REGISTER NOW

Open to public

 

CLICK HERE For additional information about this new work group.
 

AwardImageAnnouncing the 2019 MCC Champions
MCC bestows this special honor to those individuals who made significant contributions in advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials.

Please join us in congratulating the 2019 MCC Champion award recipients!

Ed Campanaro, USA
Volker Hack, Germany
Todd Johnson, USA
Nechama Katan, USA
Maria Makarovskaya, USA
Ann McCabe, USA
Aaron Nolan, USA
Heidi Shea, USA
Dorcas Speight, United Kingdom
Lien Veys, Belguim
Ravin Warnakulasuriya, USA
 


Member news icon

  Member News

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

MCC’s newest members are:

  • Corbus Pharmaceutical
  • iTrials
  • NYU Langone Health

MCC thanks the following members for their renewal:

  • CSL Behring
  • ERT
  • Novartis

Working group icon

  Work Group

MeetingTableThere’s Still Time to Help Prioritize Topics for Discussion in the Small Sponsor Community of Practice Group
MCC’s Small Sponsor Community of Practice Group (CoP) has been established in response to feedback about the unique needs of smaller-sponsor members. The MCC has designed a survey to gather input from small sponsors about how they would like to use the CoP and the topics they would like to explore.

BlueTakeSurvey
Take the Survey

 

Survey respondents will receive a summary recap of results. Your survey responses will be kept confidential.

MCC members can access the Small Sponsor Community of Practice Group Knowledge Portal where self-help resources such as short videos, implementation guides and links to relevant MCC resources are available. Access the page by logging into the MCC member portal and select the “Meetings & Work Groups” tab and then “Small Sponsor Community of Practice Group”.


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 Metrics
3rd Thursday of the Month 10AM EDT
Oct 17, 2019
Dec 5, 2019*
Imaging Performance
3rd Tuesday of the Month 10AM EDT
Oct 16, 2019*
Site Selection and Start-Up Metrics
1st Tuesday of the Month 10AM EDT
Oct 1, 2019
Nov. 5, 2019
Vendor Oversight
1st Wednesday of the Month 10AM EDT 
Nov 6, 2019
*Meeting deviates from regularly scheduled frequency.
 

MCC Best Practices Communities
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!

Best Practice Community
Meeting Frequency
Date
Centralized Monitoring
3rd Wednesday of the Month 10AM EDT
Oct 15, 2019*
Nov 12, 2019
Small Sponsor Community
of Practice
Every Other Month 11AM EDT
TBD
Study Quality Trailblazer
2nd Wednesday of the Month 10AM EDT
TBD
*Meeting 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)
Oct 3, 2019 11 AM EDT
Central Lab Metrics v3.0
Oct 9, 2019 11 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Oct 8, 2019 10 AM EDT
eCOA Metric Toolkit v2.0
Oct 3, 2019 10 AM EDT
Risk Assessment & Mitigation Management Tool v2.0
Oct 10, 2019 10 AM EDT
Site Contracting Metrics Toolkit v1.0
Oct 9, 2019 10 AM EDT
TMF Metrics Toolkit v2.0
Oct 8, 2019 11 AM EDT

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
MCC staff looks forward to having good conversations with you in 2019.

Risky Business Forum

Date: September 29, 2019
Location: Gilead Sciences, Uxbridge, UK

Session Title: “Risk Evaluation and Control – Meeting the Requirements of ICH E6(2). A worked example with Keith Dorricott, Metrics Champion Consortium Ambassador

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

Learn More

 

MAGI’s Clinical Research Conference – 2019 West

Date: October 27, 2019
Location: Las Vegas, Nevada

Session Title: Sponsors of Choice/Sites of Choice: Measuring What Matters

Session Participants:

Cerdi Beltre – Senior Vice President, Strategic Site Services – WCG
Linda Sullivan, MBA – Co-founder an Executive Director, Metrics Champion Consortium

Session Title: Site, Sponsor and CRO Metrics and Benchmarking

Session Participants:

Bishoy Anastasi, MPH MBA CCRP – Director, Clinical Research Finance – University of California Los Angeles
Cindy Carter – President – CenterWatch
Michael Farley, BS MBA PMP – Associate Director, Quality and Compliance – Alexion USA
Linda Sullivan, MBA – Co-founder an Executive Director, Metrics Champion Consortium

Learn More

 

Clinical Trials Europe 

Date: November 21, 2019
Location: Barcelona, Spain

Session Title: “The Impact of Risk-based Quality Management on Vendor Oversight”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

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’ve been reviewing data on the number of major and critical audit findings as part of our vendor oversight program. But the number is very variable and we’re not sure how best to use the data. Does MCC have any suggestions?

A: There are a number of challenges with using this metric:

  • It is a simple count without context and is not a useful indicator on its own. The number of audits in a month or quarter changes. Looking at findings per audit would help resolve this. This is referred to as “normalization”.
  • The type of audits will also be important. For example, you might want to remove “for-cause” audits as these are bound to have a large number of findings but they are targeted because of an initial concern.
  • There is a level of subjectivity with classifying audit findings. For example, at what point do multiple minor findings get considered as major? Sometimes, sensitivity by senior management to critical findings mean that something that is borderline critical will be identified as major. This adds to the noise in the data, making it difficult to interpret.
  • Other than for very large organizations, the number of findings per month or quarter is likely to be low. Monitoring data for trends based on low numbers is very challenging and likely to lead to many “false positive” signals. You might be driven to take action even though it is just by chance that one particular audit has many more than the typical number of major findings.
  • The root cause of an audit finding may have nothing to do with the vendor. It may be due to an issue at the sponsor or another vendor or CRO. Without taking account of the root cause(s), a vendor may appear to be performing poorly when, in fact, the issue is elsewhere.
  • Audit data is a lagging metric. Audits may detect issues that occurred months or even years previously and can take months to publish. Relying on this data alone will tell you little or nothing about current or future quality.

There is, no doubt, very valuable information in audits. Rather than focusing on using the data as a measurement, time may be better spent on using each audit finding as a learning opportunity – making sure you (and your vendors) have a robust approach to root cause analysis and development and completion of corrective actions. This is a critical part of a Quality Management System.

The MCC Vendor Oversight Work Group has recently launched a comprehensive set of metrics designed to assist in CRO Oversight for quality. This set includes leading metrics that can be used to indicate the likely quality going forward rather than focusing just on quality of work in the past. There is more information including a short video introducing these metrics here. Those in MCC member organizations can download the full set by logging into the MCC member site.


Education icon

  Education

Learn the Fundamentals of Risk-Based Quality Management through MCC’s eLearning Course 301
Quality management methods used to assure and control the quality of clinical trials should be proportionate to the risks inherent in the trial and the importance of the information collected. MCC’s eLearning Course 301 – Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management will help organizations understand risk-management concepts.

Presented by Linda Sullivan, MCC Co-Founder and Executive Director and Keith Dorricott, MCC Ambassador, this one-hour, hands-on, on-demand training course walks through risk management concepts, and learners apply the concepts by reviewing a case example and completing the risk assessment and control log included in the course material.  All MCC members receive a 20% discount!

At the conclusion of the course, learners are be able to:

  • Explain the concept of risk and its management
  • Describe risk management in clinical research and the relevance of ICH E6(R2)
  • Identify critical data and processes and use process maps to identify areas of risk
  • Develop risk statements and evaluate risk
  • Describe approaches to controlling risks in clinical research
  • Mitigate some common implementation challenges

To comply with ICH E6(R2), organizations have to develop and implement risk-based quality management programs. Discover how with MCC’s Risk-Based Quality Management eLearning course.

Learn more about the MCC e301 eLearning course.


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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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