Publication of new standards for clinical trial data reuse

The Clinical Research Data Sharing Alliance (CRDSA) has announced the publication of two new standards: the Standard for Sharing Clinical Study Data and the Standard for Secondary Analysis of Clinical Study Data. These standards aim to facilitate the responsible sharing and use of anonymised individual patient data (IPD) from clinical studies to support the research community and accelerate the discovery and delivery of new therapies to patients.

CRDSA developed the standards in response to 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 also benefit data contributors by ensuring that their investment in data preparation time and resources will maximise 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 end-to-end research process, 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. CRDSA believes that effective reuse of clinical trial data has the potential to transform the clinical research process and improve trial design and execution, while respecting 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,” said CRDSA CEO Aaron Mann. “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 realise the full research value of patient data.”

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