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October 2018

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  Important News

KMR Group’s Linda Martin Exploring Next Gen Benchmarking at MCC’s Clinical Trial Risk and Performance Management Summit – Early Bird Savings Ending Soon
Enjoy special savings when you register by October 17, 2018 for MCC’s first ever two-day summit in Princeton, NJ on November 14 and15, 2018. Don’t delay! Discounted pricing ends October 18.

This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Co-Founder and Executive Director Linda Sullivan. The keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, Founder of CenterWatch and clinical trials guru. KMR Group’s Linda Martin will be adding her expertise on the evolving use of benchmarks and more complex and analytical approaches to drive performance improvements.

Linda, Ken and a roster of experts will guide you through the issues that are top of mind in clinical trials metrics today:

  • How is ICH-E6(R2) changing what you need to measure? What are global regulators looking for?
  • How do metrics influence behavior? Are you rewarding firefighting or preventing problems?
  • Does your staff have the critical thinking skills needed to root out what needs to be changed?
  • Centralized monitoring. How is industry approaching key risk indicators and quality tolerance limits?
  • Getting to the root of the problem. Pros and cons of traditional analytic approaches: Is there a better way?
  • Predictive analytics. The next-level key to your success. But how do you get there?

The Clinical Trial Risk and Performance Management Summit is interactive. You’ll roll up your sleeves with speakers and fellow attendees as you tackle case studies that will bring clarity to the metrics process — and provide you with the answers you need.

Click here to view the agenda and register.
 

Don’t Forget to Register for MCC’s Upcoming Webinar: Retooling Risk-Based Quality Management Approaches in the Era of ICHE6(R2)
Discover how to develop and implement risk-based quality management programs to comply with ICH E6(R2) during this MCC hosted free webinar on October 18, 2018 from 11am-12pm EDT.

Since the release of the ICH GCP Guidance updates, the scale, complexity and costs of clinical trial is more than likely increasing. Many sponsor and partners might have limited experience with risk-based quality management approaches.

During 60 fast-paced minutes Linda Sullivan and Keith Dorricott will:

  • Explore new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • Discuss the importance of critical thinking in risk assessment and risk control
  • Explain the meaning of high and low detectability and the relevance to risk prioritization
  • Describe leading practices to improve risk assessment and quality oversight
  • Discover how to develop and implement risk-based quality management programs to comply with ICH E6(R2)

Click here to register.
 

Vendor Oversight Work Group Reviewing Quality Metrics Across MCC’s Portfolio of Metric Sets
MCC’s Vendor Oversight Work Group’s review of how to measure quality in a sponsor-CRO partnership led to the work group to take a closer look at all of MCC’s quality metrics.

The work group has selected a number of metrics that are relevant depending on the outsourced services. Additionally, they have identified some metrics to be used as starting points to develop new metrics focused on the partnership level, in particular in relationship to staff training and audit findings.

“The CAPA Work Group had previously recommended the use of the MHRA definition for critical observation,” said Keith Dorricott, MCC Ambassador and facilitator of the Vendor Oversight Work Group. “MCC’s discussions with the MHRA about the definition led to them to publish the definition on the MHRA website.”

Time-based metrics are often relatively easy to define but quality metrics can be challenging. “But it's important for us to consider quality metrics as well because otherwise we encourage speed over quality,” Keith continued. “The ultimate result might be a poorly conducted study that could be rejected by a Health Authority.”

Learn more about the Vendor Oversight Work Group.

Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.


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  Featured Work Group

Central Lab Expedited Shipment Metric Reinstated as Good Risk Indicator
Originally removed from the Central Lab Performance Metrics v2.1, the metric related to expedited shipment of lab supplies to sites was added back into the metric set after a joint meeting with the Central Lab and Centralized Monitoring work groups.

The shipment of lab supplies metric was removed because the overall cost of expediting is so small. However, looking through the lens of Quality Risk Management and thinking about risk factors, the work groups’ discussion focused on how this metric was actually a good risk indicator. The meeting’s participants examined such questions as:

  • If there is a lot of expediting for the first shipment to sites, is that because the central lab does not have the up-to-date information on expected site initiations?
  • Has the central lab assumed the shipment time will be shorter than it really is?
  • For ongoing re-supplies, if there is expediting for a particular site where there was not before, has something changed at the site?
  • Is there a site coordinator change and the new site coordinator isn't aware of the timelines?

“This is a great example of how different perspectives can lead to a rethinking of approach, something that the MCC helps to bring about time after time!” said Keith Dorricott, MCC Ambassador and facilitator of the Central Lab Metrics Work Group.

Click here to learn more about the Central Lab Work Group or contact Keith Dorricott with any questions.


Calendar icon

  Upcoming Meetings

MCC Monthly Work Group Meetings
Meetings are open to participants from MCC member organizations. To register for a work group meeting or for a detailed list of meeting dates and times, please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

 Work Group Meeting
Frequency
Date
Central Lab
1st Tuesday of the Month 10AM EDT
Nov 6, 2018
Dec 4, 2018
Central Monitoring
3rd Wednesday of the Month 10AM EDT
Oct 25, 2018*
Nov 28, 2018*
Imaging Performance
3rd Thursday of the Month 10AM EDT
TBD
Site Selection & Start-Up
2nd Thursday of the Month 10AM EDT
TBD
Study Quality Trailblazer 
2nd Wednesday of the Month 10AM EDT
Oct 25, 2018*
Oct 30, 2018*
Vendor Oversight
1st Wednesday of the Month 10AM EDT 
Nov 7, 2018
*Meeting deviates from regularly scheduled frequency.
 

MCC Metric Sets and Tools Implementation Support Group Meetings
These newly created meetings will be held on a quarterly basis to provide MCC members the opportunity to ask questions and share experiences related to implementing specific metric sets or tools.

 Metric Set/Toolkit Implementation Q&A
Date & Time
Data Management, Biostatistics & Medical Writing Toolkit 2.0
Oct 31, 2018 10 AM EDT
ECG Performance Metrics v2.1
Nov 27, 2018 11 AM EST
eCOA 2.0
Nov 27, 2018 10 AM EST
RA&MMT 2.0
Oct 30, 2018 10 AM EDT
Site Contracting Metrics Toolkit 1.0
Oct 11, 2018 10 AM EDT
TMF Metrics Toolkit 2.0
Oct 30, 2018 11 AM EDT


Take Advantage of Two Opportunities to Connect with MCC
MCC staff looks forward to having good conversations with MCC Members at the following events.

October 18, 2018
Metrics Champion Consortium FREE Webinar
Retooling Risk-Based Quality Management Approaches in the ERA of ICH E6(R2)
Your Office
Click here to register.

November 14-15, 2018
Metrics Champion Consortium/CenterWatch Event
Clinical Trial Risk and Performance Management Summit
Princeton, NJ
Click here to view the agenda and register.


Ask icon

  Ask the Experts

MCC Answers Your Metric Questions
Q: We've been measuring site contract cycle times to see if we are improving over time. When we recalculate historic data, the average cycle times increase because the contracts that take a long time are now included in the data. Is there any way to get around this to see if we are really improving or it is just that the slower contracts are yet to be included in the current data?

Meet The Experts

  Keith Dorricott
  MCC Ambassador and Director
  Dorricott Metrics and Process Improvement, LTD




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

A: This is one of the challenges with missing data. In the MCC Site Contracting Metric v1.0, the cycle times are defined very carefully to address this issue. For example, the metric for measuring the country median cycle time from draft contract sent to signed contract available looks at only those contracts which have reached the end-point within the time period in question. So, for 2017 data, you would look at all contracts in the particular country that had reached the end point of signed contract available during 2017 regardless of when the draft contract was sent to site. This data set will include the contracts that take a long time as well as those that are relatively fast. It will not need revising at a later date as new contracts become available because, by definition, it only includes contracts completed in 2017, and so it avoids the challenge of missing data.

Example

In the table below, you can see the start and end-points for the cycle times for 16 contracts. If you calculate the average cycle time for 2017 using the data for contracts started or sent in 2017 (in orange), then you have four missing data points - sites 7, 14, 15 and 16. When those contracts become available, the average cycle time for 2017 will change. However, if you calculate the average cycle time using data for contracts completed or available in 2017 (in green), there are no missing data points. Sites 11 and 13 will have their data included in the 2018 calculation as well as sites 7, 14, 15 and 16 if their contracts are completed in 2018.

Approaching the data this way means you are less likely to be fooled into believing a cycle time has reduced when really it just looks better because the longer cycle times have yet to be included in the calculation.


Education icon

  Education

MCC’s November Summit Includes Metric Training Through Interactive Group Exercise
Critical thinking skills and how metrics influence behavior are just a few areas that will be explored when participants take part in a case study group exercise during the MCC Clinical Trial Risk and Performance Management Summit November 14-15, 2018.

In this group exercise, participants will be separated into teams competing to uncover the root cause(s) of issues described in a case study. Each team will be provided with a case study packet that includes a description of the organization and outsourcing vendors, protocol synopsis, data reports, questions to explore and a worksheet to record the discussion. Teams may ask facilitators for additional information as the need arises. Teams will compare results, discuss how they worked through the analysis and reflect on lessons learned.

Click here to view the agenda and register.


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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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