Standards Released for Clinical Trial Data Reuse

The Clinical Research Data Sharing Alliance (CRDSA) has announced the publication of two new clinical study data standards.

The Standard for Sharing Clinical Study Data and the Standard for Secondary Analysis of Clinical Study Data strive to facilitate the responsible sharing and use of anonymized individual patient data (IPD) from clinical studies to support research and accelerate the discovery and delivery of new therapies. CRDSA developed the standards to overcome common challenges faced by both data contributors and researchers, particularly in areas like metadata, data completeness, and utility. The standards provide both sponsors and researchers with clear guidelines, ensuring that data is shared appropriately and reused in a way that is fit for purpose. 

“The standards are complementary and intended to work together to facilitate good science,” said Ramona Walls, executive director of C-Path and co-chair of the CRDSA Secondary Use Standards Work Group. “The standards establish consistent guidelines for responsibly sharing clinical study data and conducting robust secondary analyses of that data to advance scientific knowledge.”

CRDSA Std 1001: Standard for Sharing Clinical Study Data promotes data completeness, consistency, interoperability, and information transparency. These qualities are essential for the research community and, equally important, benefit data contributors by ensuring that their investment in data preparation time and resources will maximize research outcomes. 

CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data aims to help researchers conduct robust analyses and objectively interpret the findings generated from the use of shared patient data. The standard encompasses the research process end-to-end, and its application will reduce the risk of inadvertent errors or bias that may lead to conclusions potentially detrimental to scientific understanding and patient care. 

These standards can be applied in many scenarios, including adoption by research funders, use by sponsors to guide data governance policies, and application by journal editors to evaluate submitted research. Patient data generated through clinical trials is some of the highest-quality research data available, but only has further research value if the data is shared and reused responsibly. Effective reuse of clinical trial data has the potential to transform the clinical research process and improve trial design and execution, and it respects the patients who donate their time and their data as part of the clinical development process.

“Developing standards for patient data reuse was a core objective when we launched CRDSA in 2021,” CRDSA CEO Aaron Mann stated. “Publication of these standards is a significant milestone and the culmination of three years of hard work by a diverse and talented group of volunteer leaders. We look forward to working with the scientific community to adopt and implement these standards and realize the full research value of patient data.” 

Established in 2021, the Clinical Research Data Sharing Alliance (CRDSA) is a multi-stakeholder consortium that serves the clinical research data ecosystem. CRDSA’s mission is to accelerate the discovery and delivery of lifesaving and life-changing therapies to patients by expanding the research value of patient data from the clinical development process, academic research, and real-world settings. CRDSA creates a cooperative and inclusive forum that addresses common challenges, advocates for the value and use of patient data, and develops innovative data governance approaches that can transform the research process and improve human health.