The Pistoia Alliance has announced the launch of its freely accessible ‘FAIR4Clin guide’ to help accelerate the implementation of FAIR principles (Findable, Accessible, Interoperable, Reusable) in clinical datasets.
The not-for-profit life sciences organisation said that, while the principles have been adopted across pre-clinical research and academia, the diversity of data types, standards and regulatory requirements still continues to hamper research in the clinical space.
This includes real-world evidence, such as information from wearable devices and patient-reported outcomes, as well as clinical trial data.
Aimed at data practitioners in the clinical field, the research domain and those in the post authorisation domain, the FAIR4Clin guide provides a first comprehensive overview on FAIR resources in the clinical space.
It includes best practices to overcome fragmented datasets and make data more interoperable and machine-readable.
It is hoped that in the long term, this will better support the use of artificial intelligence in the industry, innovate clinical trial design and accelerate the transfer of data between contract research organisations and regulatory agencies, to enable new therapies to reach patients faster.
“While the importance of FAIR data is well recognised in pre-clinical research and academia, implementation is not yet at a mature phase in the clinical domain,” said Giovanni Nisato, project lead at the Pistoia Alliance.
“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,” he added.
The guide was co-authored by the Pistoia Alliance and leading experts in the field, which included AstraZeneca, Roche, Bayer, Genentech, Galapagos, the Hyve, Elixir, the University of Manchester and Oxford University.
Tom Plasterer, semantic data integration lead, oncology data science, AstraZeneca, said: “The FAIR4Clin guide has been comprehensively developed by domain experts coordinating with multiple standards bodies and data integration alliances to provide a foundation for clinical data interoperability and reuse.
“We believe this to be the perfect starting point for improved clinical data stewardship that can galvanise these efforts in the research and medical community alike.”
Nisato said the Pistoia Alliance is now calling on even more organisations to get involved in the next phase of the project, which will “examine the business value of FAIR and develop further tangible resources, enabling best practices across industries, increasing interoperability and effective collaborations”.