News

Topic: News

NEW!! MCC Site Activation Milestone Metrics Toolkit v 1.0 Now Available in the Member Portal

Friday, August 20, 2021

The MCC Site Selection & Start-Up Process Metrics Work Group – comprised of more than 250 individuals representing over 60 organizations – worked collaboratively from October 2019 to May 2021 to develop the assets contained in the Site Activation Milestone Metrics Toolkit v1.0. MCC had received feedback that the existing MCC-defined metrics in the Clinical Trial Performance Metrics v1.3 needed review and update. Processes have continued to develop since the existing metrics were defined. In addition, MCC revised the approach to defining metrics – providing much more context for the implementation and use of each metric, and defining metrics at different levels, as well as using the MCC Metrics Development Framework to help ensure metrics have a clear, defined purpose. The MCC Site Selection & Start-Up Process Metrics Work Group was formed to review the existing metrics and define new ones, as needed. The Work Group aimed to develop standardized metrics to:

  • Facilitate comparison / benchmarking across industry
  • Monitor processes and identify process improvement opportunities
  • Provide objective evidence of impact of process improvement efforts
  • Ensure the use of a balanced set of metrics (i.e. measure more than just “time”)

Additional metrics toolkits will be developed and published in 2022 as the work group completes its review of the site selection and start-up process.

More about this metric toolkit and the metric development work group can be found by visiting the MCC Site Selection & Start-Up Metrics Work Group page. MCC members can access the toolkit by logging in to the member portal.

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

CTO Podcast: Optimizing Clinical Trial Monitoring with Keith Dorricott and Linda Sullivan

Tuesday, April 27, 2021

Clinical Trial Optimization Podcast

EPISODE 19

Optimizing Clinical Trial Monitoring with Keith Dorricott and Linda Sullivan

MCC launched its groundbreaking monitoring process metrics working group last year with the purpose of developing new metrics that take into account changes in the clinical monitoring process, including risk-based assessment and centralized monitoring integration. That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). The collaborative working group started with the challenging process of developing a process map that depicts the new monitoring approach that integrates centralized monitoring with remote and onsite monitoring, Dorricott notes. The group has been utilizing the MCC metric development framework described in a previous podcast to identify critical success factors, key performance questions, and ultimately metrics that organizations can utilize to oversee and management new monitoring models. The group anticipates the first installment of metrics to be published by the end of May. Sullivan notes that MCC has knowledge portals, including those on monitoring, that members can utilize to optimize their clinical trials. For more on this topic, check out the Centralized & Site Monitoring Process Metrics page.

Subscribe today!

Apple Podcasts

Spotify

Stitcher

Android

CTO Podcast: How Organizations Can Take Advantage of MCC’s Risk Assessment and Mitigation Management Tool To Optimize Clinical Trials with Keith Dorricott and Linda Sullivan

Wednesday, April 21, 2021

Clinical Trial Optimization Podcast

EPISODE 18

How Organizations Can Take Advantage of MCC’s Risk Assessment and Mitigation Management Tool To Optimize Clinical Trials with Keith Dorricott and Linda Sullivan

MCC has developed a valuable risk assessment and mitigation management tool that organizations can use as the basis for implementing the risk-based quality management process outlined in ICH E6 (R2), section 5.0. That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Dorricott facilitates MCC’s QbD-RBQM-Quality Improvement Community of Practice Group. Dorricott describes how MCC members have worked collaboratively over the last five years to develop a Risk Assessment and Mitigation Management Tool (RAMMT) that moves beyond the RACT tool that was developed by another industry group. The initial drive was from members wanting MCC metrics to be aligned with individual risks to assist with risk scoring. Sullivan points out that when ICH E6 (R2) was released, the group conducted a gap analysis to determine whether the tool fully supported the approach outlined in the guidance. The tool was updated to support a new approach that includes identifying critical processes and data and utilizing MCC process maps and key risk indicator metrics already developed by MCC metric development groups. Sullivan and Dorricott note that it’s important for risk indicators to detect risk and emerging issues as early as possible to reduce, and maybe eliminate, the negative impacts. However, Sullivan and Dorricott add, when you’re scoring your risks, you should score the ‘as-is’ situation and document any additional mitigations such as improved detection, or additional training and guidance. Otherwise, the mitigations may not actually be implemented and the risk will be higher than anticipated. Indeed, Sullivan says, documentation is key to risk assessments now being required by regulators. This topic is covered in the white paper, MCC Risk Assessment & Mitigation Management Tool 2.0: Risk-Based Quality Management Aligned with ICH E6 (R2).

Subscribe today!

Apple Podcasts

Spotify

Stitcher

Android

MCC’s Metric Development Framework Defines Metrics That Answer Key Performance Questions

Monday, April 12, 2021

Successful performance metrics focus on what drives success across the enterprise. They help answer important questions. They have a purpose. Don’t measure things simply because you can, or that aren’t a concern for your organization. That may sound obvious, but many organizations measure things that simply don’t matter. Just because something is a problem for a competitor, or you heard it mentioned at a conference, doesn’t mean that the associated metric is meaningful to your trial or for your processes. You face challenges unique to the types of trials you’re running and the processes you have adopted. You cannot afford to waste resources on collecting, reporting and analyzing metrics that don’t answer your questions.

Learn more – podcast and download the paper.

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 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.

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!

Apple Podcasts

Spotify

Stitcher

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).