MCC WG Announcements

Topic: MCC WG Announcements

Announcements

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

Monday, April 19, 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. The initial area the member group will explore is how to build out the investigative site infrastructure to expand the delivery of patient-centric care that supports clinical research participation of under-represented patient populations. This can be achieved by improving recruitment and retention of under-represented populations at existing investigational sites and/or bringing new investigators into the clinical research setting. To support this approach, MCC Executive Director, Linda Sullivan will share a draft version of an investigative site diversity assessment tool MCC staff developed with the input of WCG colleagues and other industry subject matter experts. The tool is designed to assess how closely a site aligns with a core set of best practice approaches that support recruitment and participation of diverse patient populations in clinical research. The tool output identifies areas of strength and those that need improvement as well as suggests possible strategies and tactics that can be implemented to better align with best practices.

CoP members will be invited to provide feedback and suggest updates to the draft assessment tool. Once the review is completed, the assessment tool will be available for MCC members to pilot and provide feedback for additional modifications.

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.

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.