BC Platforms AG of Switzerland is to collaborate with a US data company to significantly increase its access to patient information for real world evidence studies. The agreement with GeneVault Lifesciences of Cambridge, US, was announced on 18 December and is expected to give the Swiss company new data sources across Asia, the Middle East, Africa and Latin America. These regions represent some of the world’s most genetically diverse yet historically under-studied populations. Currently, BC Platforms draws data from the US and Europe and to a lesser extent from the Asia Pacific and Middle East regions.
Founded in 1997 from a project at the Massachusetts Institute of Technology, US, BC Platforms collects and analyses data on patient health coming from sources other than clinical settings. The data sources can be patient registries and health insurance claims. Once analysed, this real world data becomes real world evidence that can be used to evaluate the safety and effectiveness of new medicines. Increasingly, it is also being used for drug discovery and development. With GeneVault as a new partner, BC Platforms will have access to an additional 115-plus medical facilities and more than 120 hospitals and medical centres. Financial terms of the agreement were not disclosed.
Separately, the US Food and Drug Administration announced on 15 December that it will update guidance on the use of real world evidence in regulatory submissions by relaxing a requirement that this data include confidential personal patient information. By relaxing this requirement, the agency expects to have access to information from large datasets with valuable macro-level data.
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