MCC: Imaging Performance Metrics v2.0 Infosheet

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For additional information about the MCC, please visit MCC Imaging Performance Metrics Version 2.0 Updates At-A-Glance INTRODUCTION The Value of Standardized Performance Metrics Biotechnology and pharmaceutical organizations optimize clinical trial cycle times by maintaining focus on core competencies, by outsourcing services, and by prioritizing the full utilization of resources. 1 Performance metrics are established by the drug development industry in order to measure and standardize various components of clinical development times and clinical trial deliverables. By using metrics, sponsors and their outsourcing partners can manage and track quality and resources—e.g. people, time, and money—in order to gauge the productivity and efficiency of each over the course of a clinical trial. This allows the drug industry to reduce drug development times and costs, and dramatically increase productivity while maintaining quality. Standardized performance metrics improve research & development strategies and performance, both within a company and across the entire drug development industry. Building Partnerships Around Standardized Performance Metrics In order to standardize metrics throughout the drug development industry, the Metrics Champion Consortium (MCC) was formed by biotechnology, pharmaceutical, and service provider organizations with the ultimate goal of improving the efficiency and effectiveness of clinical trials. Sponsors and service provider organizations benefit by being able to compare clinical trial performance across all of a sponsor's studies, even if they utilize multiple service providers. Together, sponsors and service providers can review performance and identify best- practice scenarios as well as opportunities for improvement—and then determine appropriate action steps to improve performance for the processes in question. Throughout the metrics development and implementation process, the MCC provides a safe harbor for over a hundred biotechnology, pharmaceutical, and service provider organizations to share best practices and learn from each other through participation in MCC learning forums and collaborative work groups. THE MCC METRIC DEVELOPMENT PROCESS The Sponsor/Service Provider Collaborative Process In 2009, the MCC Imaging Performance Metrics v1.0 definitions were released. These performance metrics were developed through a collaborative metric development process completed over an 18-month period [Figure 1]. A group of more than 20 sponsors and imaging core labs established the set of standardized Imaging performance metrics with the input of nearly 100 workgroup participants as well as other industry representatives. The mission of the group was to develop and support a baseline set of imaging performance metrics provided by imaging core labs with the intent to jointly encourage sponsors, core labs, and investigative to gain insights about their performance in order to improve effectiveness, efficiency, and appropriate levels of controls of the drug development process. MCC also developed a 1 Kaitin KI. "Pushing the Innovation Envelope: Drug Development Metrics and the Changing Dynamics of Pharmaceutical R&D." Presented at the 6th Annual Pharmaceutical Metrics Event: Driving Quality, Cost, & Time; October 16–18, 2007; Cambridge, MA.

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