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Topic: News

MCC’s Clinical Trial Optimization Podcast Show Launched July 13 – Subscribe Now!

Wednesday, July 15, 2020

MCC is pleased to announce the launch of the Clinical Trial Optimization a twice-monthly podcast that 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.

Subscribe today!

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Android

 

The podcast includes discussions with clinical research industry thought leaders and practitioners about how the industry is transforming clinical research design and operations to speed up the delivery of life-changing therapies. It is geared toward clinical research professionals, including R&D executives, clinical operations managers, study managers, data scientists, quality assurance managers, biostatisticians, principal investigators, clinical research associates (CRAs), safety monitors, clinical scientists and other healthcare professionals.

EPISODE 1

Impact of COVID-19 with Laurie Halloran

EPISODE 2

Drug Development with Ken Getz

To catch future episodes visit the MCC Clinical Trial Optimization Podcast page.

 

Inspection Readiness/TMF Community of Practice to Launch with Public Meeting

Thursday, May 28, 2020

The MCC Inspection Readiness/TMF Community of Practice Group launches 11-Jun-2020 with the presentation “COVID19 – Are you ready for remote inspections?” The group, which is comprised of MCC member organizations of various sizes that include Sponsors, CROs and Consultants, aims to share knowledge on inspections and best practices on Inspection Readiness and to explore the use of metrics, tools and checklists.

 

Come join us!

Tuesday, 11-Jun-2020 at 10 a.m. EDT REGISTER NOW (Open to public)

COVID19 – Are you ready for remote inspections?

Sholeh Ehdaivand, President & CEO, LMK Clinical Research Consulting

 

During this session, we will explore the likely change in regulatory inspections brought about by the pandemic. Some regulatory authorities already carry out part of the inspection remotely e.g. with a remote TMF review. We expect this move to more remote inspections to accelerate due to the pandemic. Maybe this will become the new normal. Are you ready for what it entails? This Community of Practice will meet on a quarterly basis to discuss specific topics.

Additional information about the new group can be found by visiting the MCC Inspection Readiness/TMF Community of Practice page.

MCC Article Looks at Bridging the Gaps in CAPA Planning and Clinical Trials

Thursday, May 21, 2020

MCC’s latest article “Bridging the Gaps in CAPA Planning in Clinical Trials,” published by Applied Clinical Trials gets to the root of why identifying and implementing preventive actions in clinical trial corrective and preventive action (CAPA) plans gets lost in the shuffle.  The article, written by Linda B. Sullivan, Executive Director, WCG – Metrics Champion Consortium, encourages connecting CAPA and risk-based quality management (RBQM) to enable real-time learning about existing risks as they evolve, in addition to ongoing identification of emerging issues and potential threats.

Read the article on Applied Clinical Trials Online (log in may be required).

MCC Releases the Vendor Oversight Finance Metric Toolkit 1.0

Friday, February 14, 2020

The Vendor Oversight Metric Development Work Group has launched its Finance Metrics Toolkit 1.0 that includes robust metric definitions for sixteen metrics and additional components to assist with metric selection, implementation and use.

The finance metrics are defined at four different levels; Portfolio, Study, Country and Investigative Site, and have clarity on purpose, definition, target and use.

The components of the toolkit are:

  • Metric Toolkit Overview and Implementation Guide
  • Metric Toolkit Overview (recorded webinar)
  • Metric Workbook

Metric Selection & Implementation Support Tools include:

  • Key Performance Questions to metrics
  • Issues to metrics
  • Basic/Advanced metrics to data elements
  • Data elements to metrics
  • Metrics reporting planning worksheet

MCC members can download the Finance Metrics Toolkit 1.0 by logging into the member portal and visiting the MCC Metric Sets and Tools page.

This release concludes the work of the Vendor Oversight Metric Development Work Group. The many accomplishments of the work group include:

  • Four metric toolkits
  • Detailed definitions of 59 metrics – developed using the MCC Metrics Development Framework
  • 28 glossary terms defined
  • Detailed guidance on relationship surveys published
  • Agreement on different approaches to aggregation of data across studies
  • 225 individuals registered to meetings representing 56 companies

The work group now moves into the metric implementation phase and no further metrics will be developed during this phase. Beginning in June, there will be quarterly Implementation Q&A meetings for Vendor oversight.

The first Implementation Q&A will be June 17, 2020 at 11AM EDT. Participants will review the metrics across all four sets for vendor oversight – timeliness, quality, finance, and relationship and have an opportunity to raise questions, discuss challenges, make suggestions on implementation. MCC members can register for this meeting by logging into the member portal, clicking the Members & Work Groups tab and scrolling down to Vendor Oversight under the Metrics Development Tab.

For additional information about the MCC Vendor Oversight Metric Toolkit v1.0 download the white paper.

Learn more about the MCC Vendor Oversight Work Group.

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

Public Invited to Compliance & CAPA Community of Practice Launch

Tuesday, February 11, 2020

The MCC Compliance & CAPA Community of Practice will launch with an online meeting 10-March-2020 at 11 am EDT.  This initial meeting of the Community of Practice will be open to the public.

REGISTER HEREOpen to Public

MCC Communities of Practice are about members helping members.  MCC hosts these online meetings and associated LinkedIn Groups for members to learn from each other by sharing case studies, discussing challenges and developing possible solutions.  The online meetings will be every two months with topics chosen by the members of the work group.  Each meeting will include a presentation and opportunity for discussion and Q&A.  Anyone from MCC member organizations can attend any of the Community of Practice meetings – just to listen, to discuss, or even to present on a topic.

Topic for the Compliance & CAPA launch meeting:

“Effective Root Cause Analysis”
Sandra SAM Sather – Vice President at Clinical Pathways
Dawn Niccum – Senior Director, QA & Compliance at inSeption Group

Subsequent meetings will be for those from MCC member organizations only.  Topics to include:

  • Categorization of issue / findings and trending
  • Effectiveness Checks – theory and practice

The Community of Practice will focus on the challenges and opportunities for compliance and CAPA processes discussing a range of topics led by members.

For additional information about this new work group, please visit the MCC Compliance & CAPA Community of Practice page.

Site Selection and Start-Up Work Group Launches with Public Meeting

Wednesday, October 30, 2019

Development of site start-up metrics and results from a public survey were the main topics during a public meeting that relaunched the MCC Site Selection and Start-Up Work Group. The well-attended meeting had 97 participants representing 35 organizations.

Citing data from the Tufts Center for the Study of Drug Development, Linda Sullivan, MCC Executive Director and Co-Founder, discussed the need for a focus on site start-up metrics. Attendees then reviewed the results from a public survey that sought input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes.

Highlights from the survey included:

  • Suggestions for changes to the high level process map which have been added to the “working version” of the high-level process map
  • Significant issues in the process that were most selected are related to the time taken for site contracting and site selection
  • Most organizations measure high level cycle times; from site selection to activation and from draft contract sent to contract final
  • Most organizations measure the proportion of sites either not enrolling or enrolling only one patient

After plotting the metrics on the high level process map, the discussion moved to how the interactions between regulatory, ethics and site contracting vary by country and site and should provide context to metric values. The MCC Metrics Development Model was described with reference to the Site Contracting Metrics 1.1, which are available for those in member organizations to download.

The next Site Selection and Start-Up Work Group meeting will be on November 5, 2019 and all future meetings will take place on the first Tuesday of the month. These meetings are only open to MCC member organizations. The work group will be using the MCC Metrics Development Framework to develop a comprehensive metric toolkit that includes basic and advanced standardized metrics that answer key performance questions related to this process.

The MCC encourages members to join the work group! The meetings are a pre-collaborative space for you to meet your industry peers, share experience and develop metrics to help our industry.

Members can register for the November 5 meeting by visiting the Site Selection and Start-Up Metrics Work Group page on the MCC member website or contact Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.

How Should You Measure and Assess New Centralized/Remote/Onsite Site Monitoring Programs?

Friday, October 4, 2019

Adoption of ICH E6(R2) Risk-Based Quality Management approaches has brought significant changes to the 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 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, the survey 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 10-Oct-2019.

The MCC work group will convene for an online meeting on 17-Oct-2019 at 10 am EDT. During the meeting, we 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?

REGISTER NOW – Open to public

For additional information about this new work group, please visit the Centralized and Site Monitoring Metrics work group page.

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