News

Topic: News

Metric Development Work Group Launching to Define Site Selection and Study Start-up Process Metrics

Tuesday, September 24, 2019

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 ethical 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 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, the survey will gather 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.

CLICK HERE to complete the survey by 25-Sep-2019.

The MCC work group will convene for an online meeting on 1-Oct-2019 at 10 am EDT. During the meeting, we 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?

REGISTER NOW – Open to public

For additional information about this new work group, please visit the Site Selection & Study Start-up work group page.

MCC 2019 Risk and Performance Management Summit Participants Rate Event as “Best in Class”

Monday, September 23, 2019

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, PA on September 4-5.

This year, the Summit focused on five themes:

  • 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, 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.

The 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. Many participants shared that they plan to bring colleagues to the 2020 Summit” stated MCC Executive Director, Linda Sullivan. “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!”.

Risk-based Monitoring Track Chair, Keith Dorricott summarized his experience, “We had some great exchanges of views and ideas amongst real 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.”

MCC will be hosting the third annual MCC Clinical Trial Risk and Performance Management Summit September 9-10, 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 panelist.

Visit the MCC Risk and Performance Management Summit website to sign up for event updates.

2019 MCC Champion Award Recipients Announced

Thursday, September 12, 2019

As the Metrics Champion Consortium (MCC) nears the completion of its fourteenth year, the original mission has stayed the same – to provide the clinical development industry with a neutral forum for sponsors and other clinical trial stakeholders to collaboratively define standardized performance metrics and tools that organizations can utilize to oversee and improve clinical trial planning and execution with the intent to drive process improvement. Although many organizations and individuals participate in MCC work groups and drive the adoption of MCC metrics by their organizations, we like to acknowledge the special contributions made by a select group of individuals.

We are pleased to announce this year’s class of MCC Champions – a special honor bestowed upon individuals who made significant contributions to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials.

Please join us in congratulating the 2019 award recipients.

2019 MCC Champion Award Recipients

Ed Campanaro, USAMaria Makarovskaya, USADorcas Speight, UK
Volker Hack, GermanyAnn McCabe, USALien Veys, Belgium
Todd Johnson, USAAaron Nolan, USARavin Warnakulasuriya, USA
Nechama Katan, USAHeidi Shea, USA

Click here for more information about the MCC Champions

 

MCC Site Contracting Metric Toolkit Updated

Wednesday, August 28, 2019

The MCC Site Contracting Metric Toolkit has been updated to include the full complement of Metric Selection and Implementation Support Tools in MCC Next Generation Toolkits.

The following metric selection and implementation supports tools were developed to guide organizations through the metric selection process:

  • Tool A: Key Performance Questions to Metrics
  • Tool B: Issues to Metrics
  • Tool C: Basic/Advanced Metrics to Data Elements
  • Tool D: Data Elements to Metrics
  • Tool E: Metrics Reporting Planning Worksheet

The metric definitions have not been modified since their original publication in August 2018.

MCC Member organizations can download the MCC Site Contracting Metrics v1.1 toolkit by logging in to the member portal and visiting the MCC Metric Sets and Tools page.

Learn more about the MCC Site Selection and Start-Up Work Group.

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

Vendor Oversight Quality Metrics Toolkit – Now Available to Members

Wednesday, July 24, 2019

The MCC Vendor Oversight Work Group – comprised of 75 individuals representing 33 organizations – worked collaboratively from June 2018 to March 2019 to develop nineteen quality oversight metrics. The work group used the MCC Metric Development Framework to explore:

  • Potential impact of ICH E6 (R2) and how success is defined and the most important performance questions that can be answered with metrics.
  • The most critical questions for the quality aspect of vendor oversight that we want metrics to help answer.
  • Tools that can be used to help select the right metrics and to calculate them.

The metrics are grouped into three categories: CRO oversight, CRO sub-contracted vendor oversight and functional oversight. A series of Key Performance Questions (KPQs) were developed to guide the metric development process.

MCC Member organizations can download the MCC Vendor Oversight Metrics v1.0 toolkit by logging in to the member portal and visiting the MCC Metric Sets and Tools page.

Learn more about the MCC Vendor Oversight Work Group.

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

MCC’s Executive Director to Participate in Public Workshop

Monday, July 15, 2019

The FDA is seeking feedback from stakeholders on the challenges, barriers and enablers that might be impacting the adoption of RBM and related opportunities to improve RBM implementation.

This public workshop – “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”, held under a cooperative agreement with the U.S. Food and Drug Administration, is an opportunity to capture stakeholder input on:

  • The extent to which organizations have implemented risk-based assessment and monitoring, including in conjunction central monitoring approaches
  • Lessons learned from strategies employed to overcome any obstacles to implementation and to continued execution of RBM
  • Enablers that support implementation and execution of risk-based monitoring
  • How stakeholders assess impact of their RBM program
  • Remaining challenges to implementation or execution that need to be addressed

The workshop is being held in Washington DC on July 17. Linda Sullivan, Executive Director WCG-Metrics Champion Consortium, will participate in two sessions:

  • Session 5: Measuring the Impact of Risk-Based Monitoring Approaches
  • Session 6: Synthesis and Next Steps

Visit the MCC Events page for additional information.

MCC Metric Selection Tools Available to Help Organizations Determine Which MCC Metrics to Use

Thursday, June 27, 2019

MCC members have used a facilitated, structured approach to develop an extensive library of 300 portfolio, study and site level time – quality – cost metrics. How do you decide which metrics to use in your program?

MCC is adding four metric selection tools to MCC metric toolkits. View the 6-minute webinar to learn more!

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.

Small Sponsor Knowledge Portal Launched to Support Small Sponsor Community of Practice

Tuesday, June 25, 2019

On June 4, MCC unveiled a new online Small Sponsor Knowledge Portal that includes resources such as short videos, implementation guides and links to relevant MCC resources.

The knowledge portal was established to provide a newly forming Small Sponsor Community of Practice with a single place to find MCC resources and for community members to share case studies, templates, etc.

The Community of Practice will meet online on a bi-monthly basis to:

  • Share ideas and practical approaches that work in small sponsor settings
  • Get up-to-date news about MCC Performance Metric Sets and Tools
  • Provide feedback about how MCC can support small sponsors
  • Learn from their peers

Halloran Consulting and other members of MCC community who work with smaller-sized sponsors have offered to participate in the online meetings to share insights and facilitate discussions. MCC will conduct a brief survey to gather input about future topics to be discussed by the members of the community of practice.

MCC members can access the Knowledge Portal by logging into the member website, clicking on “Meetings and Work Groups” and selecting the MCC Small Sponsor Community of Practice Group.

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.

MCC’s Linda Sullivan Looks Forward to Connecting With You During DIA

Friday, June 21, 2019

Linda Sullivan, Executive Director, Metrics Champion Consortium will be moderating the session “Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring” on June 25 at 10:30 AM during the 2019 DIA Global Annual Meeting in San Diego. Linda will be joined by presenters Sherry Merrifield, Senior Director, Global Operations Management, Syneos Health; Ann McCabe Director, Process Excellence and Risk Management, Daiichi Sankyo Inc; and Suzanne Lukac Senior Account Director, CluePoints.

Presentations will focus on the following topics:

  • Bridging risk assessment and a centralized, data-driven strategy
  • Links between quality risk management, CAPA and the learning organization
  • Improving risk assessment through post-study evaluation

Interested in meeting with Linda? Please contact Terry Holland, MCC Director of Membership to set up meeting time.

New MCC Central Lab “Next Generation Metric Toolkit” Includes Metric Selection and Implementation Tools

Friday, May 17, 2019

MCC is pleased to announce the introduction of “Next Generation Metric Toolkits” that include significant upgrades, metrics segmented by level (portfolio/study/site), metric selection tools and a metric reporting planning worksheet.

After undergoing an extensive review, the MCC Central Lab Metrics v3.0 toolkit is now available on the member portal. MCC plans to release additional enhanced metric toolkits over the next 6 months. Why are the updates important? These tools solve a major problem for organizations seeking to adopt MCC standardized metrics, namely how to select the right metrics for their program.

  • answer key performance questions (identified by consortium members)
  • manage common issues (identified by consortium members)
  • provide the basic measures all organization should adopt
  • can be reported based on availability of data elements

In addition to the metrics selection tools, a metric reporting planning worksheet has been developed that sponsors/vendors teams or internal teams can use to record which metrics are going to be used, who will report the metrics and how often metric results will be reviewed.

MCC members can download the updated Central Lab Performance Metrics v3.0 by logging into the member website and clicking on the Existing Metrics Sets tab.

 

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.