Industry Nonprofit Issues Standards for Sharing Clinical Research Data
In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that would make research data shareable among sponsors, clinical trial sites and regulators.
Put together by Pistoia and a diverse array of stakeholders in 2016, the Findable, Accessible, Interoperable and Reusable (FAIR) principles are designed to make data, especially data in text format, reusable and machine-readable by AI solutions by applying standard terminology and metadata formats.
According to the alliance, clinical trials currently produce fragmented datasets due to unharmonized metadata, making existing data variety and veracity issues worse and creating data silos that do not allow for data interoperability or reuse.
The FAIR principles are well-known in preclinical research and academia but remain at an early stage of adoption in clinical research, says Giovanni Nisato, project lead at the Pistoia Alliance. This first iteration of the guide, dubbed FAIR4Clin, provides recommendations and tools to help organizations build a data management plan based on the FAIR principles.
“This guide will accelerate the adoption of FAIR principles and the move towards improved data standards in the clinical sector, ultimately creating a more collaborative research ecosystem that will bring new therapies to patients faster,” Nisato said.
A number of big-name drugmakers advocate for the FAIR principles, including Roche, which calls them “a main pillar” of its R&D strategy, and AstraZeneca, which calls the newly released guide “the perfect starting point for improved clinical data stewardship.”
Lack of interoperability in the clinical research industry is a high-profile problem that WCG Chief Product Officer Rahul Bafna recently described as “critical to driving innovation and bringing new treatments to patients” (CenterWatch Weekly, Jan. 16).
Access the guide here: https://bit.ly/40kkZki.
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