Metrics

Topic: Metrics

Site Selection and Start-Up Work Group Launches with Public Meeting

Wednesday, October 30, 2019

Development of site start-up metrics and results from a public survey were the main topics during a public meeting that relaunched the MCC Site Selection and Start-Up Work Group. The well-attended meeting had 97 participants representing 35 organizations.

Citing data from the Tufts Center for the Study of Drug Development, Linda Sullivan, MCC Executive Director and Co-Founder, discussed the need for a focus on site start-up metrics. Attendees then reviewed the results from a public survey that sought input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes.

Highlights from the survey included:

  • Suggestions for changes to the high level process map which have been added to the “working version” of the high-level process map
  • Significant issues in the process that were most selected are related to the time taken for site contracting and site selection
  • Most organizations measure high level cycle times; from site selection to activation and from draft contract sent to contract final
  • Most organizations measure the proportion of sites either not enrolling or enrolling only one patient

After plotting the metrics on the high level process map, the discussion moved to how the interactions between regulatory, ethics and site contracting vary by country and site and should provide context to metric values. The MCC Metrics Development Model was described with reference to the Site Contracting Metrics 1.1, which are available for those in member organizations to download.

The next Site Selection and Start-Up Work Group meeting will be on November 5, 2019 and all future meetings will take place on the first Tuesday of the month. These meetings are only open to MCC member organizations. The work group will be using the MCC Metrics Development Framework to develop a comprehensive metric toolkit that includes basic and advanced standardized metrics that answer key performance questions related to this process.

The MCC encourages members to join the work group! The meetings are a pre-collaborative space for you to meet your industry peers, share experience and develop metrics to help our industry.

Members can register for the November 5 meeting by visiting the Site Selection and Start-Up Metrics Work Group page on the MCC member website or contact Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.

How Should You Measure and Assess New Centralized/Remote/Onsite Site Monitoring Programs?

Friday, October 4, 2019

Adoption of ICH E6(R2) Risk-Based Quality Management approaches has brought significant changes to the site monitoring processes. The processes have changed – how do you evaluate and manage these new monitoring approaches?  Do metrics used to oversee “traditional” site monitoring processes still apply? The industry needs come together to develop a new set of standardized metrics that align with the new emerging approaches of risk-based site monitoring. MCC is launching a new work group to develop a comprehensive set of performance metrics in this important area. During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, the survey gather input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.

CLICK HERE to complete the survey by 10-Oct-2019.

The MCC work group will convene for an online meeting on 17-Oct-2019 at 10 am EDT. During the meeting, we review survey results and discuss the following aspects related to the process of centralized, remote and site monitoring:

  • What does the high-level process look like?
  • What are the process issues organizations are encountering?
  • What are the important questions that we want metrics to help us answer?

REGISTER NOW – Open to public

For additional information about this new work group, please visit the Centralized and Site Monitoring Metrics work group page.

Metric Development Work Group Launching to Define Site Selection and Study Start-up Process Metrics

Tuesday, September 24, 2019

MCC is launching a metric development work group to define site selection and site study start-up process metrics. In 2018, MCC released the MCC Site Contracting Metric Toolkit v1.0 that includes detailed metric descriptions and Global Start-Up Comparison Models that group countries into five models according to the impact that local regulatory and ethical approval processes have on the site contracting process. This new MCC work group will build upon the foundation established in the site contracting toolkit and examine the overall process of site selection and start-up. Our goal is to collaboratively develop standardized metrics that can be used across industry to monitor, manage and improve the process. During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, the survey will gather input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.

CLICK HERE to complete the survey by 25-Sep-2019.

The MCC work group will convene for an online meeting on 1-Oct-2019 at 10 am EDT. During the meeting, we review survey results and discuss the following aspects related to the process of site selection and study start-up:

  • What does the high-level process look like?
  • What are the process issues organizations are encountering?
  • What are the important questions that we want metrics to help us answer?

REGISTER NOW – Open to public

For additional information about this new work group, please visit the Site Selection & Study Start-up work group page.

MCC Site Contracting Metric Toolkit Updated

Wednesday, August 28, 2019

The MCC Site Contracting Metric Toolkit has been updated to include the full complement of Metric Selection and Implementation Support Tools in MCC Next Generation Toolkits.

The following metric selection and implementation supports tools were developed to guide organizations through the metric selection process:

  • Tool A: Key Performance Questions to Metrics
  • Tool B: Issues to Metrics
  • Tool C: Basic/Advanced Metrics to Data Elements
  • Tool D: Data Elements to Metrics
  • Tool E: Metrics Reporting Planning Worksheet

The metric definitions have not been modified since their original publication in August 2018.

MCC Member organizations can download the MCC Site Contracting Metrics v1.1 toolkit by logging in to the member portal and visiting the MCC Metric Sets and Tools page.

Learn more about the MCC Site Selection and Start-Up Work Group.

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

Vendor Oversight Quality Metrics Toolkit – Now Available to Members

Wednesday, July 24, 2019

The MCC Vendor Oversight Work Group – comprised of 75 individuals representing 33 organizations – worked collaboratively from June 2018 to March 2019 to develop nineteen quality oversight metrics. The work group used the MCC Metric Development Framework to explore:

  • Potential impact of ICH E6 (R2) and how success is defined and the most important performance questions that can be answered with metrics.
  • The most critical questions for the quality aspect of vendor oversight that we want metrics to help answer.
  • Tools that can be used to help select the right metrics and to calculate them.

The metrics are grouped into three categories: CRO oversight, CRO sub-contracted vendor oversight and functional oversight. A series of Key Performance Questions (KPQs) were developed to guide the metric development process.

MCC Member organizations can download the MCC Vendor Oversight Metrics v1.0 toolkit by logging in to the member portal and visiting the MCC Metric Sets and Tools page.

Learn more about the MCC Vendor Oversight Work Group.

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

MCC Metric Selection Tools Available to Help Organizations Determine Which MCC Metrics to Use

Thursday, June 27, 2019

MCC members have used a facilitated, structured approach to develop an extensive library of 300 portfolio, study and site level time – quality – cost metrics. How do you decide which metrics to use in your program?

MCC is adding four metric selection tools to MCC metric toolkits. View the 6-minute webinar to learn more!

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.

Which Metrics Should I Select? Central Lab Tools Help You Select the Right Metrics

Friday, February 15, 2019

The Central Labs Work Group has been developing tools to help with selection of metrics. They have used the comprehensive set designed for the Site Contracting metrics as a starting point and are very pleased with the results to date.

One of the tools the work group is most proud of helps to recommend metrics based on issues that you have (or risks you have identified) and then highlights recommended metrics and the data elements that are needed to calculate those metrics. An excerpt from the tool below shows how it works. Two issues have been selected and the recommended metrics are highlighted in green.

Central Lab tool excerpt

At the work group meeting in February, team members expanded on the issues and associated metrics. This tool will help organizations implement the metrics that will have the most benefit. This is one of a number of methods the MCC has developed to help organizations select the right metrics.

MCC members can register for future Central Lab Work Group meetings by logging into the member portal and clicking here.

Not Member?
Email MCC Membership Director, Terry Holland to learn how your organization can join.

Accenture Introduces New Analytics Capabilities in the Accenture Life Sciences Cloud for R&D: Collaborates with the Metrics Champion Consortium to develop the Clinical Operations Insights Platform for Improved Visibility into Clinical Trial Performance

Monday, June 26, 2017

MCCACCENTURE

NEW YORK; June 26, 2017 – Accenture (NYSE: ACN) has developed and introduced a new analytics platform to provide real-time insights on the status and performance of clinical trials for the life sciences industry. The platform, known as the Clinical Operations Insights Platform (COIP), is a module of the Accenture Life Sciences Cloud for R&D, an industry platform for running clinical trials that deliver better patient outcomes.

Accenture has joined forces with the Metrics Champion Consortium (MCC) in the development of COIP, using MCC’s industry clinical trial metrics to measure a company’s clinical trial performance. MCC is an open, collaborative organization devoted to the development of standardized metrics to improve clinical trials.

Accenture’s COIP is designed to help life sciences companies leverage descriptive and predictive analytics using operational data to gain real-time insights about the status and performance of a clinical trial. Accenture’s experience has shown that the COIP can help life sciences companies increase the operational efficiency of clinical trials by as much as 30 percent. The platform gives life sciences clinical operations managers greater flexibility to manage clinical trial programs from anywhere, anytime, by consolidating into a single analytics platform internal and external data sources across clinical trial management systems, electronic data capture systems and clinical research organization partners.

“We are excited about our collaboration with MCC and the addition of their clinical operations performance metrics into our Clinical Operations Insights Platform module”, said Kevin Julian, who leads Accenture’s Life Sciences practice in North America “Together we are integrating technology with metrics standards, making it easier for our clients to understand the health of their study portfolio, manage their business more effectively and bring their treatments to patients.”

MCC has also joined the Accenture Life Sciences Cloud Coalition, which includes Eli Lilly, GSK, Merck, Pfizer, and other prominent pharmaceutical companies. As a member of the coalition, MCC will provide input on the use of standardized performance metrics in the Accenture Life Sciences Cloud for R&D. The aim of the Accenture Life Sciences Cloud Coalition is to enable the R&D function, speed up the drug development process while improving quality and cost for the industry.

“We are pleased to build MCC’s standardized metrics into the Accenture Life Sciences Cloud for R&D Clinical Operations Insights Platform and to welcome Accenture as a member of our consortium”, said Linda Sullivan, co-founder, and president of MCC. “Our members are looking for innovative ways to implement and effectively utilize the standardized metric sets and tools developed in our collaborative working groups – having access to MCC standardized performance metrics in the Accenture Life Sciences Cloud for R&D platform is a win-win for current and future users.”

About Accenture

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With more than 411,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com

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.

Contacts:

Teresa Holland
Metrics Champion Consortium
+ 1 317 622 0266 ext. 108
tholland@metricschampion.org

Cam Granstra
Accenture
+1 312 693 5992
cameria.l.granstra@accenture.com

Help Industry Develop Standard Metrics for Site Payments-MCC Site Payments Process Industry Survey

Thursday, April 27, 2017

As an industry, we have a challenge with site payments. Site payment delays have been cited as one of the key concerns by investigators. Data from the Society for Clinical Research Sites (SCRS) says that 66% of sites report having less than three months’ operating cash on hand, and lengthy delays in payment result in high turnover rates among clinical investigators1. The Clinical Trials Transformation Initiative (CTTI) shows as many as 40% of sites drop out of FDA-regulated clinical trials due to lengthy delays in payments2. By standardizing metrics in this important area, the industry will be better able to baseline, compare, manage and improve performance and ultimately increase the available pool of sites for clinical trials.

The Metrics Champion Consortium is conducting this survey as a baseline exercise before developing metrics. We invite industry Sponsor, CRO and Clinical Trial Site Payment Vendors to participate in this 11 question survey. All responses will remain confidential to the MCC – only de-identified data will be shared in the executive summary and final report. Professionals who complete the survey and include their email address will receive an executive summary.

TAKE SURVEY

1SCRS White Paper on Site Payments[http://www.prnewswire.com/news-releases/site-payment-white-paper-released-by-the-society-for-clinical-research-sites-300352486.html]

2CTTI Outsourcing-Pharma.com Article[http://www.outsourcing-pharma.com/Clinical-Development/Payment-tech-automates-reimbursements-to-clinical-trial-sites]

MCC Article Urges Industry to Standardize Data Entry Metric Definition and Use Performance Data to Improve Data Entry Compliance

Wednesday, April 26, 2017

Linda Sullivan, MCC President, and Keith Dorricott, MCC Ambassador – discussed the results of the 2016 MCC Site Data Entry Practices Survey in their article “Importance of Data Entry Timeliness” published by Applied Clinical Trials. The article reveals that organizations consider timely data entry to be very important but face challenges with measuring and monitoring the data input process. A newly released MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” provides industry’s perspective on the cycle time from subject visit to data entry by investigative sites, and how organizations use the performance data to improve data entry compliance.

About the Survey

MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing this and other MCC Industry Practices Insight Reports, please email Customer Service
or visit our Industry Practices Insights Report Page

Read Linda Sullivan and Keith Dorricott’s article on Applied Clinical Trials Online