CRDSA releases report on data platforms supporting real-world data in regulatory submissions

CRDSA's paper highlights the role of data platforms in regulatory submissions, supporting prior clinical trial data (pCTD) and real-world data (RWD) use for improved trial efficiency.

The Clinical Research Data Sharing Alliance (CRDSA) has announced the publication of a new paper, “Data Reuse in Regulatory Submissions: The Role of Data Platforms.” This paper addresses the role of data platforms in supporting the use of pCTD and RWD in regulatory submissions. Specifically, the paper explores how these platforms can facilitate the use of supplemental and external controls, offering potential benefits like reduced patient recruitment, shortened timelines, and improved trial feasibility – especially for rare diseases.

Data platforms are essential in enabling trial sponsors to access patient data from both real-world settings and prior clinical trials. “While there are differences in how prior clinical trial data and RWD are generated, collected, and prepared, the assessment dimensions are essentially the same,” said Robert S Miller, Chief Medical Science Officer at CancerLinQ®. He added that the approach for RWD may differ from pCTD due to the less standardized nature of RWD, which is typically collected outside of protocol-driven research settings.

The CRDSA paper provides clear recommendations on how data platforms can support sponsors in meeting health authority expectations. These recommendations span the data lifecycle, including data collection, documentation, transparency, and quality assurance processes.

Emily S Brouwer, VP Epidemiology at Parexel International, emphasized the importance of data quality in this context:

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“In any regulatory submission, health authorities and sponsors must be confident in the quality, authenticity, and provenance of the data being used. However, non-traditional data sources like prior trial and RWD when used as supplemental and external controls require an evolution of the standard randomized controlled trial data evaluation process.”

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The paper’s recommendations are informed by several key frameworks, including FDA guidance, the HMA-EMA Data Quality Framework, and CRDSA’s Standard for Sharing Clinical Study Data. By following these practices, data platforms can enhance the quality and credibility of the data they provide, improving their ability to meet regulatory requirements.

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“We recognize that implementing some of the recommendations may require additional effort from data platforms and sponsors,” said Andrew J Belli, MPH, Vice President of Research at COTA. “As a data ecosystem, we need to work together to achieve standards that enable regulatory acceptance and ultimately improve patient outcomes.”

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