Metrics

Topic: Metrics

MCC Special QM Webinar, “How Regulators are Supporting the Quality Management and Risk Based Procedures in ICH GCP E6 (R2)” featuring guest speaker Ann Meeker-O’Connell, Former FDA Director of the Division of GCP Compliance.

Wednesday, February 1, 2017

The International Conference on Harmonisation’s R2 addendum to the ICH E6 Guideline for Good Clinical Practice (GCP) provides direction on a new approach to clinical monitoring and trial management that requires the use of centralized, quality risk management (QRM) throughout a clinical trial. Sponsors and CROs that are adapting to the changes are approaching this in a variety of ways. That leads to the question, what will regulators expect from organizations as they integrate the new guidelines into their SOPs?
The presentation on January 11th , open to all MCC members, focused on the processes and behaviors that the FDA and other regulators are promoting through the quality management and risk-based guidance in ICH-E6(R2) section 5.0 Quality Management. This should be of interest to all organizations whether you have already integrated the changes into your practices or are just starting to plan for the integration.

MCC Members can access this and other Subject Matter Expert Webinars by clicking the Member Login link and going to the MCC Initiative Updates section of the Member Homepage. Scroll down and click on the SME Webinars link.

Please contact Linda Sullivan for additional information.

Learn more about membership options and register to become a member of the MCC

For questions about membership options contact MCC Membership Director, Teresa Holland.

Ann Meeker-O’Connell heads Bioresearch Quality and Compliance for Johnson & Johnson’s consumer sector with responsibility for Good Clinical Practice (GCP), Good Laboratory practice (GLP) and Safety Vigilance oversight. Prior to J&J, Ann served as Director of the Division of Good Clinical Practice Compliance at the U.S. Food and Drug Administration (FDA). At the FDA, Ann led Agency initiatives related to innovative models for clinical trial conduct and oversight, advised on clinical trial policy and regulation development, and oversaw FDA’s GCP collaboration with European Medicines Agency (EMA). Ann earned her Bachelor’s in Biological Anthropology and Anatomy and a Master of Science in Pharmacology from Duke University in Durham, NC.

MCC Co-Founder & President Linda Sullivan Featured in Applied Clinical Trials’ New eBook on RBM

Wednesday, December 14, 2016

ACT eBook
Linda Sullivan’s article “Standardized Metrics for RBM” is now featured in Applied Clinical Trials’ new 5th edition eBook Risk-Based Monitoring in Clinical Trials: A Focus on Quality Risk Assessment, Management and Planning. The article which focuses on the adoption of standardized cost and quality performance metrics to track and predict performance is featured among several other articles by various authorities in the field of clinical trials that together address questions such as:

  • Have the roles of the monitor advanced?
  • How are CRAs accepting the change?
  • How is pharma implementing RBM—is it more remote, centralized or a combination?
  • How important is eSource to RBM?

Download Applied Clinical Trials’ New eBook

Purchase MCC’s New RBM Survey Report

MCC eCOA Performance Metrics Set v1.0 Now Available

Wednesday, November 23, 2016

MCC member companies have developed an initial set of eCOA Metrics to measure the quality, timeliness and effectiveness of their setup, use and closeout of eCOA services. Utilization of these metrics will enable organizations to understand how well the process is being executed and managed throughout study start-up, conduct and closeout. The eCOA metric set and a number of supporting reference tools are available to MCC members.

MCC eCOA Performance Metrics v1.0 At-A-Glance

MCC Performance Metrics

An overview presentation of the metrics was recorded and has been posted on the MCC Members Website.

Presentation Outline

  • Background – MCC eCOA Working Group Purpose, Deliverables and Approach
  • Overview of MCC Metrics Development Model
  • Overview of the eCOA Critical Success Factors
  • Overview of the eCOA Map
  • Overview of the Key Performance Questions
  • Overview of the eCOA Performance Metrics

eCOA Performance Assets Available to Download from the MCC Member Website

  • A recorded eCOA Basics Webinar
  • Recorded eCOA Overview Presentation
  • eCOA Metrics Process Map
  • Detailed MCC eCOA Performance Metric Definitions (Wiki Terms are included with the metrics definitions)

MCC Members can access all of these resources by clicking the Member Login link and going to the Existing Metric Sets section of the website. Scroll down to the table of existing metric sets.

Please contact Linda Sullivan for additional information.

Learn more about membership options and register to become a member of the MCC

For questions about membership options contact MCC Membership Director, Teresa Holland.

CluePoints Partners with Metrics Champion Consortium to Define Metrics and Standards for Centralized Monitoring

Monday, November 7, 2016

CluePoints

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring (RBM) solutions for clinical trials, announces its partnership with the Metrics Champion Consortium (MCC), an association dedicated to the development of standardized performance metrics to improve clinical trials. Drawing on the company’s vast expertise in Risk-Based Monitoring, CluePoints will work with the consortium to help drive collaboration in the development of a standardized framework for Central Monitoring, including identification and definition of what is included, who should be involved, and how best to manage the process.

“We are excited to have the opportunity to lead such an important initiative for the Metrics Champion Consortium” comments Steve Young, Senior Vice President of US Operations at CluePoints. “The industry is finally beginning to move forward to large scale adoption of RBM, yet there remain many questions on the topic of Central Monitoring, and so we look forward to driving clear guidance and standards for this critical component of RBM success.”

The Metrics Champion Consortium has created the Central Monitoring work group to help facilitate the exchange of knowledge and expertise in standardization of clinical risk management. Known for organizing work groups with the intention of providing metrics for the clinical trials industry, MCC has engaged CluePoints to work with them to more clearly define what Central Monitoring is for the industry.

“We are delighted that CluePoints will lead our Central Monitoring work group” comments Linda Sullivan, Co-Founder and President of Metrics Champion Consortium. “Results from our recent Risk-based Approaches to Monitoring Industry Survey show an increasing number of organizations use/plan to use central monitoring approaches in the next 12 months as compared to two years ago. This new MCC work group will bring sponsors, CROs, central & core labs, consultants and IT system vendors together to explore what key risk indicators, performance metrics and data should be included in central monitoring, what analytic approaches should be used to gain valuable insights and how organizations should use the insights to ensure patient safety and improve data quality. CluePoints’ experience with centralized monitoring and risk-based monitoring make the company ideally placed to bring the community together to share insights and align thinking to established, shared global standards.”

About CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

For further information on CluePoints’ solutions, please visit www.cluepoints.com

Media contact

Patrick Hughes – Chief Commercial Officer, CluePoints

Patrick.Hughes@CluePoints.com

+44 (0) 7703 532 749

About the Metrics Champion Consortium

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

For more information about MCC publications, metric sets & tools, metric education programs and how you can participate in future surveys and MCC work groups, please visit http://www.metricschampion.org

Contact:

Linda B. Sullivan – President, Metrics Champion Consortium

Lsullivan@metricschampion.org

1.317.622.0266 ext 102

Clinical Trials Insight Article Reveals New Clinical KPI Survey Findings

Thursday, October 27, 2016

Ken Getz—MCC owner, Director of Sponsored Research at the Tufts CSDD, and Chairman of CISCRP—discussed the new KPI survey findings in his article “Finally, Standardized KPIs are Front and Center” in Applied Clinical Trials Online.  The article explains the various challenges organizations have been facing in the collection and application of relevant metrics, the main factors driving the widespread adoption of standardized metrics, and how the majority of organizations are using KPIs.

Read Ken Getz’s article on Applied Clinical Trials Online

Please visit MCC Survey Reports for more information.

About Metrics Champion Consortium (MCC)

Significant Growth—67% Increase Over Past Two Years—in the Use of RBM in Pivotal Clinical Trials

Thursday, October 20, 2016

Boston, MA., October 20, 2016—Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—announced today a newly published report, “An Updated Look at Risk Assessment and Risk-based Management Practices,’ revealing the industry’s acceptance of risk-based monitoring across all phases of clinical trials and regions. The report also features new content on the use of formal risk assessment as a tool for identifying causes of risk that could affect the collecting of critical data or the performance of critical processes prior to a clinical trial.

Among the key findings:

  • Top sources organizations use for project/protocol review is EDC (83%), CTMS (66%), and Central Labs (60%)
  • Majority of organizations are conducting risk assessments prior to study conduct (69%)—fewer are repeating assessments during study conduct
  • Use of web portals and secure document exchange has increased to 56% in 2015, up from 36% in 2013
  • Top reasons organizations are implementing RBM shifted from reducing monitoring costs-78% in 2013-to improving quality oversight (83%) and data quality (85%) in 2015
  • Traditional 100% SDV monitoring decreased from 75% in 2013 to 62% in 2015

“The significant increase in the use of risk-based monitoring approaches signals that the industry has moved from the early adopter to the early majority innovation adoption phase,” said Linda Sullivan, co-founder and president at the industry group Metric Champion Consortium, author of the new report.  “Additionally, our analysis shows that the data analytic approaches being utilized to support risk management and RBM programs are growing in sophistication and will continue to do so in the next 12 months. Standardizing performance metrics are the linchpin that support these analytic platforms.”

MCC conducted the online survey between November 2015 and January 2016 as a follow-up to the seminal work piloted by MCC in 2013, the first survey to examine organizational approaches and e-data sources driving risk-based monitoring (RBM) programs.
For more information on purchasing the “An Updated Look at Risk Assessment and Risk-based Management Practices,” please email customerservice@metricschampion.org or visit http://metricschampion.org/rbm/

About Metrics Champion Consortium (MCC)

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit http://www.metricschampion.org

Contact:
Linda Sullivan
lsullivan@metricschampion.org
317-622-0266

Standardized Metrics for Better Risk Management

Friday, September 9, 2016

MCC Co-Founder/President Linda Sullivan’s new article “Standardized Metrics for Better Risk Management: The Right Data at the Right Time” posted on Applied Clinical Trials calls for the adoption of standardized cost and quality performance metrics to track and predict performance. View at http://bit.ly/2cpNvNw

MCC eTMF/TMF Metrics Leadership Team Progress Webinar

Tuesday, December 22, 2015

The Metrics Champion Consortium (MCC) held a member only session on 20 November that provided an update on the progress made by the MCC’s eTMF/TMF Metrics Leadership Team. During the session, the MCC outlined the stages of the MCC Metrics Development Process, a proposed basic and advanced Metric Framework that accommodates paper and eTMF processes and a TMF Artifacts Mapping Tool (based on the TMF RM V3).

During the session, the MCC also announced the launch of a new survey where it will ask members for feedback regarding the TMF Critical Success Factors (CSFs) and Key Performance Questions (KPQs) discussed during the webinar.

If you are a MCC member and wish to participate in the guided review of the TMF metrics, log onto the MCC Member Portal to see the list of open surveys which includes, Guided Review of TMF Key Performance Questions. Contact Customer Service for any assistance.

Survey results will be shared with a now-forming MCC TMF Working Group that will make recommendations on the initial set of TMF metrics. You can signup to be part of this working group at the end of the survey.

The MCC also has available the recording of this session for MCC members. This can be found in the Workgroup News section of the TMF Workgroup page on the MCC Member Portal.

Please contact Linda Sullivan at lsullivan@metricschampion.org for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

MCC Members Learn About electronic Clinical Outcome Assessments (eCOA) and Begin to Define Performance Metric Set

Monday, December 21, 2015

In early 2015, Metrics Champion Consortium (MCC) member organizations – sponsors and electronic Clinical Outcome Assessment (eCOA) vendors – requested that the MCC facilitate the development of a standard set of eCOA performance metrics to include in the growing MCC library of clinical metric sets. They believed that the time was right to establish an initial set of measures since the use of eCOA (sometimes referred to as electronic Patient Reported Outcomes – ePRO) has continued to grow and evolve. This growth is partially due to it being one of several tools that helps support the current emphasis on patient-centered clinical research.

In response, MCC launched the eCOA Performance Metrics Initiative to define a standardized set of eCOA performance metrics to be used by clinical trial sponsors, CROs and eCOA vendors to assess the timeliness, quality and effectiveness of the eCOA setup and data collection services. Utilization of these metrics will enable organizations to understand how well the process is being executed and managed throughout study start-up, conduct and closeout.

During the first phase of metric development process, MCC worked exclusively with the eCOA Leadership Team – comprised of representatives from ten member organizations (sponsors, eCOA vendors, CROs) – to establish the foundation on which to build the metric set. Specifically, they used the MCC Metrics Development Process to develop an eCOA Process Map, define nine eCOA Critical Success Factors (CSFs) and draft 28 Key Performance Questions (KPQs). In the final phase of the development process, MCC members will define a set of metrics that answer the high priority KPQs.

Additionally, members of the Leadership team hosted an eCOA Basics webinar to provide MCC members with an overview of eCOA that included topics such as, Types of eCOA measures, the eCOA Regulatory Landscape, and the Impact on Data Quality and Subject Retention. MCC members are invited to visit the Education and Training section of the MCC Member Portal to view the archived recording of the session [free of charge] as well as additional information about the eCOA Metrics Initiative.

MCC Member Feedback Survey

MCC is conducting a brief survey designed to gather information from MCC Member organizations about the eCOA CSFs and KPQs. If you are a MCC member and wish to participate in the guided review of the eCOA CSFs and KPQs, log onto the MCC Member Portal to see the list of open surveys which includes, MCC Member Guided Review of eCOA/ePRO Key Performance Questions (KPQs). Survey results will be shared with a now-forming MCC eCOA Working Group that will make recommendations on the initial set of eCOA metrics. You can signup to be part of this working group at the end of the survey.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland. MCC Members are invited to contact Customer Service for assistance with establishing user accounts and accessing the MCC Member Portal.

MCC Clinical Trial Performance Metric Sets Ready for a Checkup

The MCC Clinical Trial Performance Metrics as well as several other metric sets are a few years old and it’s time for them to be reviewed for improvement opportunities. MCC is launching multiple metric set checkups by inviting all MCC members to participate in a guided review process.

While many of the MCC metrics provide the desired performance feedback needed in organizations, it’s likely that there are others that require enhancing. MCC members with metrics experience will have the opportunity to influence change in metrics that may need enhancing or to affirm the metrics that should remain as is. Over 80 metrics are up for review.

New Way to Classify MCC Metric Sets

The MCC is aligning the metrics for review with the MCC Development Process that was released in 2015. The process consists of:

  • Critical Success Factors (CSFs), which describe what must be done well to be successful,
  • Key Performance Questions (KPQs), which identify what you need to know to determine whether the CSF is being achieved, and
  • Metrics, which answer the KPQs.

Each metric set will be released for review as the metrics that support a Critical Success Factor (CSF). There are a total of 13 CSFs that align with clinical trial areas of responsibility such as Site Performance, Data, Monitoring, Safety and Vendor Oversight. Regardless of your functional area, you’ll want to review the metric sets for CSFs that align with your areas of responsibility.

To learn more about the MCC Metrics Guided Review Initiative, we invite members to log onto the MCC Member Portal. At the top of the homepage you will see links to a table of the CSF metric sets along with a link to download the companion document to the initiative titled, “Overview of the MCC Metric Sets Guided Review Initiative“. The CSF table contains links to five metric sets that are available to review now. MCC will continue to release metric sets though January 2016 and will announce each metric set ready for review through emails and LinkedIn as soon as it becomes available.

Survey results will be shared with a MCC Working Group for each CSF that will make recommendations for their metric set. You can signup to be part of a working group at the end of each metric set’s guided review.

Please contact Linda Sullivan for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.