MCC Releases Protocol Operational Complexity Tool

Monthly Archives: December 2017

MCC Releases Protocol Operational Complexity Tool

Wednesday, December 20, 2017

Carmel, IN – MCC’s Study Quality Trailblazer Work Group is excited to release its first iteration of the MCC Protocol Operational Complexity Tool. It is designed to assign an operational complexity rating at subject, site and study levels.

“I have often wondered about the reliability of comparing performance between studies and sites using historical metrics but not taking account of the study operational complexity,” said Linda Sullivan, MCC Co-founder & President who launched the MCC Study Quality Trailblazer Work Group in 2016. “In discussions with member organizations, we thought there would be real value in developing a tool to assess operational complexity. Taking complexity into account means better metric comparisons and ultimately better decisions on site selection, comparisons between CROs and Sponsors, and on subject burden, which impacts recruitment and retention.”

The Protocol Operational Complexity Tool will:

  • Help determine an operational complexity rating based on the protocol and implementation
  • Generate a rating for subject, site and study
  • Allow organizations to focus on elements that are contributing to operational complexity to determine if actions can be taken to reduce that complexity

The tool is designed in Excel to be simple to use. It provides guidance on rating of each of the complexity elements. The complexity elements are aligned with the TransCelerate Risk Assessment and Categorization Tool (RACT).

View the webinar on the MCC website. Members can view the full webinar and toolkit by logging into their MCC user accounts.

For more information please contact Keith Dorricott or Linda Sullivan.

 

About Metrics Champion Consortium

MCC is a trusted partner in the clinical trials industry to identify what to measure and assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. We continually bring you new insights into the leading trends within the industry. For more information, please visit www.metricschampion.org.

Contact:

Jane Jones
MCC Markeing Manager
jjones@metricschampion.org
(317) 622-0266 ext. 110

 

 

Cost of Poor Quality Estimator Tool Presentation Hot Topic at Clinical Performance Metrics Summit

Tuesday, December 12, 2017

Philadelphia – Linda B. Sullivan, MCC’s Co-Founder & President, generated a lot of conversation after her presentation, Apply the Total Cost of Quality Model to Clinical Trials to Quantify the Cost of Poor Quality to Gain Insights About Investing in Quality, and how the MCC Cost of Poor Quality (CoPQ) Estimator Tool can help during the Clinical Performance Metrics Summit, December 4, 2017.

Stressing that the cost of quality matters, Sullivan described the Total Cost of Quality Model as investing in quality through value-added prevention and appraisal activities (e.g. quality by design, in-process checks, scheduled audits, inspection, reviewing reports, monitoring) and reducing non value-added activities (e.g. major protocol amendments, non-enrolling sites, data queries, subject dropouts, “fire-fighting” activities).

“The Cost of Quality Model has been used by many industries as a tool to balance investing in quality versus fixing quality problems when they occur,” said Sullivan. “It is time for the drug development industry to use the Cost of Quality Model to help them make quality investment decisions.”

Acknowledging that quantifying the cost of poor quality can be difficult, Sullivan discussed the development and value of the MCC CoPQ Estimator Tool – an Excel-based tool developed with input from the MCC Study Quality Trailblazer Team Work Group. The CoPQ Estimator tool can be used to estimate the financial impact that poor quality has on study costs. Specifically, the tool considers three categories of poor quality costs:

  • Direct, operational costs (16 items total)
  • Cost of study extension (time x $)
  • Delay to market costs

The flexible tool includes “default” values derived from industry studies for seven direct cost items, which users can override if company-specific data is available.

Click here to view Sullivan’s presentation and to learn more about the MCC Study Quality Trailblazer Team Work Group.

 

About Metrics Champion Consortium

MCC is a trusted partner in the clinical trials industry to identify what to measure and assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. We continually bring you new insights into the leading trends within the industry. For more information, please visit www.metricschampion.org.

Contact:

Jane Jones
MCC Marketing Manager
jjones@metricschampion.org
(317) 622-0266 ext. 110

MCC Releases Set of Nine Portfolio-level Milestone and SUSAR “Timeliness” Performance Metrics

Friday, December 1, 2017

Carmel, IN — The Metrics Champion Consortium’s (MCC) Vendor Oversight Work Group has published its first set of portfolio-level metrics designed to answer high-priority vendor performance questions related to achieving timeliness goals. Specifically, the five performance metrics report whether 10 study milestones are achieved by established milestone dates. The group explored different data aggregation options and decided to define metrics that help answer the following Key Performance Questions:

  • Are milestones being delivered “on-time” across active studies?
  • Are milestones being delivered “on-time” across studies over a three-month period?
  • Are milestones being delivered “on-time” within each study phase (start-up, conduct, closeout)?

“The new consensus-based portfolio-level milestone metrics represent a significant expansion of MCC’s extensive catalogue of metric definitions,” said Linda Sullivan, Co-Founder & President of MCC. “The MCC Vendor Oversight Work Group defined 10 study milestones and considered the pros and cons of different metric aggregation models when developing the metric set. We look forward to the release of additional portfolio-level vendor oversight quality, cost and relationship metrics in 2018.”

Additionally, the group defined four performance metrics measuring the timeliness of SUSAR reporting.

Each metric definition includes 15 components, including metric formula, data definitions and performance targets. MCC members are invited to visit the member portal to download the metric toolkit.

The Vendor Oversight Work Group is now exploring options for measuring sponsor/vendor relationships.

Two White Papers detailing the Vendor Oversight Work Group’s metric development process and the group’s overall approach are now available to download on the Vendor Oversight Work Group page on the MCC website.

To view the press release in a PDF format, click here.

About Metrics Champion Consortium

MCC is a trusted partner in the clinical trials industry to identify what to measure and assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. We continually bring you new insights into the leading trends within the industry. For more information, please visit www.metricschampion.org.

Contact:

Jane Jones
MCC Marketing Manager
jjones@metricschampion.org
(317) 622-0266 ext. 110