The Clinical Content & Reuse (CC&R) initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents (e.g., Common Protocol Template, Statistical Analysis Plan, and Clinical Study Report) that can be reused throughout the project lifecycle to enable digitization and traceability through automation. The initiative’s guiding principles include a streamlined and consistent structure and content that can be used across multiple documents and processes, and is aligned with Good Clinical Practice (GCP), ICH and EU requirements, with elements drawn from Clarity and Openness in Reporting (CORE) Reference.
Our annual release continues to provide benefits to regulators, investigator sites, patients, and research sponsors.
The 2020 release includes these key changes:
- Focus on Content Reuse: Updates to the implementation tools and CC&R website provide more focus on how the Clinical Template Suite (CTS) and tools enable content reuse across the clinical development ecosystem.
- Updates to Template Content: CTS content enhancements have focused on alignment with ICH E9 (R1) estimands recommendations, registry (ClinicalTrials.gov) content quality, and user-driven feedback on template clarity.
- Updates to eTemplates: Updates to the eTemplates seek to minimize barriers to adoption by providing support/guidance on customizing libraries, aligning with content updates, and improving functionality to accommodate more complex trial designs.
- Enhanced Patient Centricity & ClinicalTrials.gov Registration: In partnership with the Clinical Research Access & Information Exchange initiative, the Common Protocol Template is now integrated with the Clinical Trial Registration Tool to enable evaluation of the quality and patient friendly text of the brief title and brief summary data, and can now export 35+ data fields for automating quality registry submissions to ClinicalTrials.gov.
This year, the team is also excited to present an updated graphic that illustrates the interconnectedness, continued growth and development of the CC&R Initiative. Presented as three interconnected triangles, the image denotes the close relationships among the clinical template suite, harmonized model content and reuse capabilities. The initiative is grounded by its guiding principles and flexible implementation options.
Looking ahead, the team anticipates a busy 2021 as they will continue to make content enhancements, including enhancing eTemplates to minimize adoption barriers. They are also assessing adoption of new automation technologies, including a clinical trial registration tool and a ClinicalTrials.gov export profile.
By Mark Makurath, Head of GCD Standards & Training Excellence at Merck