MCC WG Announcements

Topic: MCC WG Announcements

Announcements

New MCC Vendor Oversight Community of Practice Group Launching on 07 April 2021

Thursday, March 18, 2021

MCC’s Vendor Oversight Metric Development work group will transition to a Community of Practice group in April 2021. MCC vendor oversight metric sets have been developed and members are ready to form a Community of Practice group. Community of Practice groups are a virtual community of MCC members that share a common interest or concern who meet on a regular basis to share ideas and practical approaches to address challenges. Meeting topics are determined by members of the Vendor Oversight Community of Practice.

The initial meeting will feature Linda Sullivan, Co-Founder and Executive Director, MCC and Keith Dorricott, MCC Ambassador leading a discussion on the use of metrics in vendor oversight. Topics to be discussed include:

  • The impact of metrics on behavior
  • Vendor oversight vs the process perspective
  • What metrics do and do not tell you
  • Advantages and challenges of standardizing metrics

The MCC Vendor Oversight Metric Development work group – comprised of more than 200 individuals from 56 companies – developed four metric toolkits between April 2017 – January 2020 which include detailed metric definitions, implementation guides, metric selection tools and demo videos in addition to an overview video.

  • MCC Vendor Oversight Finance Metric Toolkit 1.0 – a metric set focused on the financial oversight of CROs. Includes rate of incurring costs, accuracy of budget, cycle times for contracts and change orders, and investigator site payment timeliness.
  • MCC Vendor Oversight Quality Metric Toolkit 1.0 – a metric set focused on the quality oversight of CROs / vendors. Includes staff turnover, training, issue escalation, action completion, and includes metrics covering sub-contractor oversight.
  • MCC Vendor Oversight Timeliness Metric Toolkit 1.0 – a metric set focused on the timeliness of meeting milestones and SUSAR reporting across studies.
  • MCC Vendor Oversight Relationship Assessment Metric Toolkit 1.0 – a metric set for use when analyzing data from a relationship survey between sponsor and CRO or CRO and vendor. The toolkit includes detailed guidance on setting up, implementing and analyzing data from a survey.

The toolkits are available for members to download in the MCC member portal.

The session is open to all MCC Members – contact MCC for registration details.

For more information about the Community of Practice Group, please visit MCC website.

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

MCC’s Study Quality Trailblazer Group Relaunched as QbD-RBQM-Quality Improvement Community of Practice Group

Wednesday, March 17, 2021

MCC’s Study Quality Trailblazer Group was started in 2016 as the first MCC Community of Practice Group (CoP). Since its inception, MCC members have shared ideas, challenges and lessons learned which led to the development of a suite of risk and quality management tools. The new name QbD – RBQM- Quality Improvement CoP better describes the scope of topics explored by this growing MCC virtual community. During the March 10 meeting, Ken Getz, Michael Wilkinson and Zak Smith from Tufts Center for the Study of Drug Development joined the group to present the key findings and implications from their 2020 study on protocol design practices and their impact on clinical trial performance and efficiency. During the next QbD-RBQM-Quality CoP meeting, the group will explore opportunities to update MCC protocol metrics and quality tools to incorporate new benchmarks shared in the Tufts Center study.

The session is open to all MCC Members – contact MCC for registration details

Additional information about this MCC Community of Practice Group is available on the MCC website

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

MCC AI/ML Community of Practice Group Group Convening Expert Panel to Explore “Using Machine Learning and Artificial Intelligence to Support Clinical Trials”

The MCC Artificial Intelligence / Machine Learning Community of Practice Group will host a panel discussion on 23 March at 11AM EDT to explore the topic: Using Machine Learning and Artificial Intelligence to Support Clinical Trials. 

Panel Moderator: Keith Dorricott, MCC Ambassador

Panelists:

  • Lucas Glass – VP, Analytics Center of Excellence, IQVIA
  • Ashley Howard – Associate Director, Asset Lead, Pfizer
  • Ilan Man – Head of Data Science and Analytics, Lokavant
  • Jonathan Rowe – Head of R&D Quality and Risk Management, ZS Associates

This promises to be a fascinating session with representatives from those who build ML/AI models, to an end-user and an experienced consultant in the industry. We’ve already had some interesting questions submitted – on whether AI/ML is just for big pharma, and strategies for overcoming resistance, for example.

The session is open to all MCC Members – contact MCC for registration details.

Additional information about this MCC Community of Practice Group is available on the MCC website.

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

MCC Small Sponsor Community of Practice Group Announces Meeting Topics

Monday, February 15, 2021

Small sponsors have unique needs – that’s why MCC created the Small Sponsor Virtual Community of Practice to provide a place for small sponsors to hear what’s going on at the MCC, share ideas and practical approaches that work in small sponsor settings, and to learn from peers.  This group holds virtual meetings on a bi-monthly basis.

The schedule of topics for the first half of 2021 include:

  • How do Small Sponsors Use Quality Tolerance Limits? Provide feedback to the MCC member QTL sub-team (24 February 2021)
  • Defining KPIs with CROs – Simple? (28 April 2021)
  • Relationship Surveys – we just need to decide the questions, right? (23 June 2021)

The MCC Small Sponsor Community of Practice has its own landing page and Knowledge Portal in the MCC member portal. The Knowledge Portal includes many resources such as slides and recordings of the above topics, short video demonstrations, and implementation guides. Topics covered in 2020, included:

  • Vendor Oversight for Small Sponsors
  • Inspection Readiness in Small Sponsors
  • Successful Sponsor-Vendor Relationships
  • Small Sponsors Working with CROs: Getting RBQM to Work
  • Implementing Metrics for a TMF Process at a Small Sponsor

Additional information about this MCC member group can be found by visiting the MCC Small Sponsor community of practice page. MCC Members can log onto the MCC member portal to register for the sessions.

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

Ken Getz to Join MCC Study Quality Trailblazer Group Meeting on 10 March

New benchmarks on protocol design practices and their impact on clinical trial performance and efficiency will be discussed at the MCC Study Quality Trailblazer Community of Practice meeting on March 10, 2021.

Ken Getz, Michael Wilkinson and Zak Smith from Tufts Center for the Study of Drug Development will present the key findings and implications from their 2020 study. The results from this working group study show that scientific and operating complexity is continuing to rise with notably variation by disease condition. The study presents new insights into the volume and diversity of data collected per clinical trial and provides new benchmarks and insights into adaptive and master protocol designs. Join us to hear the findings first-hand and ask your questions.

Additional information about this MCC member group can be found by visiting the MCC Study Quality Trailblazer community of practice page. MCC Members can log onto the MCC member portal to register for the session.

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

MCC Forming Sub-team to Explore QTL Topics and Develop Toolkit

Wednesday, October 21, 2020

“Predefined quality tolerance limits” were introduced to ICH GCP in revision 2 of ICH E6 in 2016. They are mentioned in two paragraphs but with no guidance on how to define or use them. We know from MCC meetings and at the recent MCC Summit, where a working group discussed quality tolerance limits (QTLs) in detail, that many organizations are struggling to implement them. Indeed, over one third of MCC Summit working group participants said they do not currently even use QTLs. We have also had discussions that show many in the industry are confused with the concept and the terminology. For example, a QTL is a threshold level of a measurement parameter but the term is often used to describe the measurement rather than the threshold.

The MCC Centralized Monitoring Community of Practice meeting on 18-Nov-2020 at 10am EST will feature a panel session and open discussion: “Challenges with QTL Implementation”. Following the meeting, MCC will convene a sub-team of industry Subject Matter Experts (SMEs) interested in working collaboratively to catalogue the questions and challenges organizations face with QTL implementation and create a QTL toolkit.  MCC experts will lead the group through the process of developing a MCC QTL implementation toolkit that expands our understanding about QTLs, applies “measure the right things at the right time” concepts developed by MCC and assists organizations in implementation. The sub-team will report progress to the Centralized Monitoring Community of Practice on a regular basis. The work will culminate with the publication of an article in an industry journal.

Additional information about this MCC member group can be found by visiting the Centralized Monitoring Community of Practice page. For information about the QTL Sub-Team CLICK HERE.

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

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.

Updated Cardiopulmonary Process Metrics Toolkit Now Available to Members

Thursday, May 21, 2020

The MCC Cardiopulmonary Process Metrics Toolkit v2.2 (ABPM, ECG, and Spirometry metrics) is now available for MCC member organizations to download from the portal.

Thank you to all who provided input and feedback as we carried out this update. The toolkit includes “core” metrics that are applicable to the set-up, conduct and oversight of ambulatory blood pressure monitoring (ABPM), electrocardiogram (ECG) and spirometry services in clinical trials. Additionally, the toolkit included ABPM-, ECG- and spirometry-specific metrics. The update includes the following modifications:

  • Consolidation of all metrics into one metric workbook – comprising the core metrics, and ABPM-, ECG- and Spirometry-specific metrics.
  • Metric “Core 3” has been split into two metrics – one measuring the proportion of sites where equipment was shipped on time and another measuring the proportion of sites where equipment is reported as having an error. In the original metric, the measurement was for the proportion of sites where equipment was received on time and members agreed that this was very challenging data to collect.
  • Performance targets updates for the ECG metrics 1a, 1b and 1c, and the example formula corrected for 1b and 1c.
  • The glossary has been added to the metric workbook – similar to other MCC metric sets.
  • Metric selection tools and implementation support tools have been developed

The changes were reviewed and accepted by MCC members in March 2020. Please visit the MCC Cardiopulmonary Process Metrics Work Group page for additional information.

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

MCC Imaging Process Metrics Toolkit v3.0 Now Available

Thursday, May 14, 2020

The MCC Imaging Process Metrics Toolkit v3.0 is now available for MCC member organizations to download from the portal. Thank you to all who provided input and feedback as we carried out this extensive update. The updated metric toolkit includes the following:

  • Updated Metric Definitions
    • Portfolio / Study / Site level metrics
    • Basic / Advanced metric designations
    • Potential Key Risk Indicators
  • New toolkit overview, implementation guide and introductory webinar (13 mins).
  • Updated process map
  • Additional components to assist with your implementation and use of the metrics:
    • Four metric selection tools which help you select the right metrics for your situation and to list the associated data elements needed
    • A metrics reporting planning worksheet to help plan the reporting of the metrics you select

Please visit the MCC Imaging Process Metrics Work Group page for additional information.

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

New Forum on Navigating Clinical Trial Operational Challenges Amid COVID-19 Crisis

Friday, April 3, 2020

Metrics Champion Consortium Unveils New Forum to Foster Dialogue on Navigating Clinical Trial Operational Challenges Amid COVID-19 Crisis

Virtual Roundtable Brings Together Industry Stakeholders for Weekly Discussions on How to Measure Risk and Study Performance as Coronavirus Pandemic Evolves

Falls Church, VA – April 3, 2020 – Metrics Champion Consortium (MCC), an industry organization dedicated to improving clinical trials via the development of standardized performance metrics, today announced the launch of a new forum designed to spur discourse on the impact of the coronavirus outbreak on clinical trials and how to tackle operational challenges associated with the ever-evolving pandemic. The weekly, virtual series – the MCC COVID-19 Community of Practice – connects MCC members, representing more than 80 organizations across the global life sciences ecosystem, and provides them with opportunities to share knowledge and collectively think about how to proactively address common industry concerns around risks to trial integrity and benchmarking study performance amid the COVID-19 crisis.

Founded in 2006, MCC is part of WCG’s Study Planning and Site Optimization Division. From biopharmaceutical and medical device trial sponsors to clinical research organizations (CROs), research sites and technology service providers, member organizations utilize MCC’s network to collaborate through working groups focused on addressing shared challenges and opportunities. In light of the COVID-19 pandemic and recent guidance from regulatory bodies on conducting clinical trials, MCC is leveraging its platform to bring together a diverse, global network of clinical research stakeholders to discuss how they are coping with disruptions to study operations as a result of quarantines, site closures, travel limitations, interruptions in the supply chain for the investigational product and infection of site personnel and trial participants, among other ongoing developments. A document summarizing the topics discussed as well as links to relevant consortium resources and regulatory guidance documents are posted in the consortium’s COVID-19 knowledge portal.

“The fallout from the spread of COVID-19 infections will continue to have major implications for clinical trial operations, and we’re committed to doing our part to support our community in navigating through unchartered territory,” said Linda Sullivan, executive director of MCC. “In bringing together MCC members for timely discussions and to regularly compare notes, our goal is to create a forum that drives the knowledge sharing and collaborative thinking that will help to meaningfully address common challenges and offer practical, actionable solutions.”

Donald A. Deieso, PhD, Executive Chairman and CEO of WCG, added: “Collaboration across the clinical trial ecosystem and healthcare more broadly has never been more critical. With the coronavirus pandemic growing rapidly as each day passes, we know that we are all in this together and must find our way through a devastating global health crisis by collaborating and supporting each other. Leveraging its unmatched benchmarking capabilities and insights, MCC is making it possible for the industry to think through needed new metrics and their implications, while working together to determine how to consistently measure performance in an evolving clinical trial landscape.”

Weekly COVID-19 Community of Practice discussions will explore top-of-mind questions on virtual patient visits, risk management and control, centralized monitoring, protocol deviations and amendments, and informed consent form amendments, as well as other topics suggested by members. MCC resources, including a web-based knowledge portal and LinkedIn Group, will also be available to members so that they can share challenges, questions and learnings in real time.

To learn more about MCC membership, please contact Teresa Holland, Membership Director at tholland@metricschampion.org or 1-317-622-0266.

About Metrics Champion Consortium
MCC is the leading industry consortium that brings clinical research stakeholders together, including sponsors, CROs, partners and investigational sites, to collaboratively develop standardized performance metrics and associated tools that help organizations oversee, manage and optimize clinical trial execution.  For more information, please visit www.metricschampion.org.

About WCG
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two divisions – the industry’s first central IRB – WIRB-Copernicus IRB, and first clinical services organization (CSO) – WCG enables biopharmaceutical companies, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protection. For more information, please visit www.wcgclinical.com  or follow us on Twitter @WCGClinical or LinkedIn.

Media Contacts:
MCC: Linda B. Sullivan
317-622-0266
lsullivan@metricschampion.org

WCG: Amy Hutnik
609-250-7654
ahutnik@wcgclinical.com