MCC WG Announcements

Topic: MCC WG Announcements

Announcements

MCC Group to Discuss Using ML and AI to Support the Clinical Trial Enterprise

Monday, February 15, 2021

The MCC Artificial Intelligence / Machine Learning Community of Practice Group will host a panel discussion on 23 March to explore the topic: Using Machine Learning and AI to Support the Clinical Trial Enterprise. 

Panel Moderator: Keith Dorricott, MCC Ambassador

Panelists:

  • Ashley Howard, Associate Director, Asset Lead, Pfizer
  • Jonathan Rowe, Head of R&D Quality and Risk Management, ZS Associates

Following the panel discussion, meeting participants will have the opportunity to ask questions and discuss the topic in further detail.

Additional information about this MCC member group can be found by visiting the MCC AI/ML Knowledge Sharing Group 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 Small Sponsor Community of Practice Group Announces Meeting Topics

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

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.

Protocol Complexity Case Study to be Presented at January Study Quality Trailblazer Meeting

Wednesday, December 18, 2019

Dr. Frank M. Berger, Head of Analytics, Global Clinical Operations at Boehringer Ingelheim, will present “Case Study – Protocol Complexity” during the January 23, 2020 Study Quality Trailblazer meeting at 10AM EST.

Dr. Berger will cover the following topics:

  • What is complexity?
  • Trial complexity and protocol complexity
  • Common beliefs around trial complexity
  • Different perspectives
  • How to measure trial /protocol complexity
  • Call to action: Let’s collaborate!

MCC members can register for the January 23 meeting by visiting the Study Quality Trailblazer Work Group page on the MCC member website.  Contact Lara Knitter, MCC Customer Service & Product Support for assistance.

Learn more about the Study Quality Trailblazer Best Practice Community.

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