MCC WG Announcements

Topic: MCC WG Announcements

Announcements

What Attributes Do Sponsors Seek When Selecting Investigative Sites Capable of Recruiting Under-Represented Patient Populations to Participate in Clinical Trials? Can You Assess Sites Against the Attributes?

Friday, July 23, 2021

These topics will be explored in the MCC Patient Diversity Community of Practice Group virtual meetings on August 12 and September 9, 2021. During the August meeting, the group will review a draft list of attributes, add and/or modify the attributes and brainstorm about how to measure / assess site capabilities.

The September meeting will be held jointly with the MCC Site Selection and Start-Up Process Metrics work group for a broader discussion about today’s approaches to select sites capable of enrolling under-represented participants in clinical trials and explore opportunities to expand the selection criteria in the future.

MCC members can log in to the member portal to register for the sessions.

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

MCC Members to Explore How Artificial Intelligence Can Improve TMF Health

MCC members are invited to a special joint meeting of the MCC Inspection Readiness/TMF and AI/ML Communities of Practice on September 14 to discuss artificial intelligence applications to support and improve TMF filing. During this presentation, Gonzalo Uribarri and Robert Toal from IQVIA Clinical Technologies will share insights on the changing face of eTMF in a presentation entitled, “The future of eTMF: Auto-filing using AI”. The MCC Inspection Readiness / TMF Community of Practice has often discussed the challenges of a complete and accurate TMF. Is this an area where Artificial Intelligence can help us? Join us for a fascinating presentation, Q&A and discussion.

Additional information about these groups can be found by visiting their home pages:

MCC Artificial Intelligence (AI) / Machine Learning (ML) Community of Practice

MCC Inspection Readiness / TMF Community of Practice

MCC members can log in to the member portal to register for the session.

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

MCC Inspection Readiness/TMF Community of Practice Discusses Challenges of Conducting TMF QC

Friday, June 25, 2021

At the bi-monthly virtual meeting on 8-Jun-2021, we had panelists Ashley Appleton (Eli Lilly), Dawn Niccum (inSeption), Robert Toal (IQVIA), and LoriAnn Verna (Just In Time GCP) exploring the topics of TMF QC. There was high interest in the topic with record registrations and many questions and comments from attendees. Areas discussed included the frequency of QC, the practicalities of QC, definitions of terms such as “duplicate”, and the potential for using Natural Language Processing to assist with filing. The meeting included live polling which revealed that 44% of those who responded do not typically carry out root cause analysis when the TMF QC does not meet the required standard. This generated discussion on the panel.

Additional information about this group can be found by visiting the MCC Inspection Readiness/TMF Community of Practice page. MCC members can log in to the member portal to view the recorded session.

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

Participation in MCC Community of Practice Virtual Groups Continues to Increase

Friday, May 21, 2021

Due to member demand, we have continued to expand our offering of topic areas in our Communities of Practice. MCC Communities of Practice are where members help members. To see a short video on how our Communities of Practice work, click here.

Two recent meetings had over 150 registrants:

  • The Centralized Monitoring Community of Practice, where the topic was “Is the industry headed to 0% SDV? How does SDR fit into the picture?” We used live polling, a whiteboard for brainstorming, and had great discussion and idea sharing. The brainstorm outputs have been categorized and are available to those in MCC member organizations to download and share.
  • A joint meeting of the Audit, Compliance & CAPA Community of Practice and the AI/ML Community of Practice, where Jonathan Rowe, ZS Associates, presented on “Advanced Analytics for Audit Data: Will it happen and did it happen again?” Discussing how we might use audit and other data better really got people thinking – as the volume of questions in Q&A demonstrated.

Both sessions were recorded and are available to those in MCC member organizations through the MCC member portal.

Additional information about MCC member groups can be found by visiting the MCC Work Groups page.

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

 

 

Inaugural Meeting of the Patient Diversity Community of Practice Group 10 Jun 2021

Monday, April 19, 2021

Original post updated May 20, 2021

MCC is pleased to announce the launch of the MCC Patient Diversity Community of Practice (CoP) Group on 10 June 11:00 AM – 12:00 PM EDT. The purpose of the Patient Diversity CoP is to provide a forum for MCC members to share best practices and discuss common challenges they encounter increasing participation of under-represented patient populations in clinical research. During the initial meeting, MCC will provide an overview of the existing quality tools that encourage engagement with patient groups and support the development of patient centric studies. Following the existing tools overview, meeting attendees will be asked to answer polling questions and participate in a virtual brainstorming session to prioritize the topics and possible metrics and/or tools the group will focus on in 2021 and beyond. Areas of interest already suggested by members include:

  • Assessing the short-term progress and long term success of patient diversity programs
  • Assessing site capabilities to select sites that will achieve patient diversity targets
  • How to enlist your CROs to practice diversity and measure the impact

Don’t miss this chance to join your peers to share ideas, collaborate and make a difference. Contact MCC Executive Director Linda Sullivan (lsullivan@metrcischampion.org) for additional information.

MCC members are invited to log into the member portal to register for the 10 June meeting or contact MCC for further details.

Additional information about this MCC member group can be found by visiting the Patient Diversity 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.

Upcoming Meeting – “Advanced Analytics for Audit Data: Will it happen, and did it happen again?”

Thursday, April 15, 2021

The MCC community of practice groups Audit, Compliance & CAPA  and Artificial Intelligence/Machine Learning will host a joint meeting on 11 May 2021 at 11AM EDT “Advanced Analytics for Audit Data: Will it happen, and did it happen again?” 

Jonathan Rowe, Head of R&D Quality and Risk Management, ZS Associates will present on using audit data for predicting the likelihood of site audit findings. Additionally, he will explore using machine learning and Natural Language Processing for determining CAPA effectiveness. There will be opportunity for Q&A and discussion after the presentation.

For additional information about these community of practice groups visit the MCC Artificial Intelligence/Machine Learning page and the MCC Audit, Compliance & CAPA  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.

eCOA Process Metrics Work Group Expanding Coverage of the Metric Toolkit

Wednesday, April 14, 2021

The utilization of eCOA/ePRO services has accelerated in recent years, fueled in part by the COVID pandemic. In late 2020, the MCC eCOA Process Metrics Work Group conducted a review of the eCOA metric set v2.0 (released in October 2018) and identified several areas that needed exploration to address gaps. The first area of focus considered was the translations process. They started by developing a high-level process map, which required multiple iterations before finalization. Work Group members found the process map very useful for establishing the Key Performance Questions and metrics needed to address the gap.

At the April 2021 meeting, they will move on to discuss another key part of the process – training. Currently, the metric toolkit includes a metric measuring staff training completion. However, the group plans to cover a full range of training, including site staff and study participants (for ePRO). Additionally, they will explore how to measure whether the training is effective. In subsequent meetings, they will discuss whether additional study conduct metrics related to data quality should be added, too.

Additional information about this MCC member group can be found by visiting the eCOA Process Metrics work 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.

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.