South San Francisco, CA, October 22, 2024 — The Clinical Research Data Sharing Alliance (CRDSA) is pleased to announce the publication of “Data Reuse in Regulatory Submissions: The Role of Data Platforms.”
This paper examines the benefits and challenges of using supplemental and external controls in regulatory submissions. Data platforms are an integral part of the ecosystem, enabling trial sponsors to access and use patient data from real-world settings and prior clinical trials. The paper recommends specific steps data platforms can take to support sponsors in meeting health authority expectations.
“In any regulatory submission, health authorities and sponsors must be confident in the quality, authenticity, and provenance of the data being used” said Emily S. Brouwer, MPH PharmD PhD, VP Epidemiology, Parexel International. “However, non-traditional data sources like prior trial and real-world data when used as supplemental and external controls require an evolution of the standard RCT data evaluation process.”
The data platform practices recommended in the paper are informed by sources that include FDA guidance documents, the HMA-EMA Data Quality Framework, and CRDSA’s Standard for Sharing Clinical Study Data. The recommendations span the data lifecycle, including collection, documentation, transparency, data format, and quality assurance (audit/traceability).
“While there are differences in how prior clinical trial data and real-world data are generated, collected, and prepared, the assessment dimensions are essentially the same,” said Robert S. Miller, MD, Chief Medical Science Officer, CancerLinQ®. “However, the specific approach recommended for RWD may, of necessity, be different from prior clinical trial data, since RWD is typically collected outside of a protocol-driven research setting and is not subject to harmonized requirements, including the use of specific data standards, comparable to those of a trial.”
By outlining clear expectations to support the regulatory use of supplemental and external controls, CRDSA aims to highlight the central role played by the data platform. Data platforms that can demonstrate and document data quality will be well-positioned to meet the needs of submitting sponsors and regulators.
“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.”
About CRDSA
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.
Media Contact:
Sara Mesenbrink
Clinical Research Data Sharing Alliance
+1 415-322-3360
admin@crdsalliance.org
