Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
European Medicines Agency (EMA) and Multi-Regional Clinical Trials (MCRT) release data anonymisation report – EMA
In a workshop report titled Data anonymisation – a key enabler for clinical data sharing the EMA discusses the global landscape for clinical data sharing, the foundations of data anonymisation, the mechanics of anonymisation and meeting the challenge of different datatypes, balancing access and data utility, and the future challenges for data anonymisation.
Read the full paper.
To access the rewards of big data in health care, potential risks must be managed – Outsourcing-Pharma.com
A guest columnist summarizes five key takeaways from a symposium of industry leaders, regarding the ethical risks and rewards surrounding the emergence of big data in healthcare.
Read the full guest column.
EudraCT releases version 10 – EMA
In November, the EMA released EudraCT version 10.4.4.0 to fix a known bug associate with the site. The bug changed results that were “Posted and Finalised” to “Draft” when accessing the “Managed Assigned Users” page. This has been fixed and any results that were incorrectly changed have been restored.
Read the release notes.