Sam and Ivanna speak to Mark Wheeldon, the CEO of Formedix, about that there was once a time where sponsor companies would name their trial variables whatever they wanted, and the regulatory bodies had to make sense of sponsor-specific data labelling. This made it hard to look across trials to identify potentially identical applications - and catch potential risks for patient safety.
Then along came CDISC. A cross-industry consortium collaborating to create data standards. Not only setting the standard for data labelling, but also making it easier to build standard programs to analyse the data. The models of CDISC are extendable, meaning you can build on the existing models while adding novel data sources. Despite great progress in this space, a lot of the standard technology is aging:
“SAS transfer files are still common in our industry. Can you imagine the banking industry using technology standards from the 80’s?”
Covid challenged the study setup timelines and the frequency of data availability. The mappings were evolving. Storing mappings and spacing the mappings allows for rapid change and saves time on double coding. As the trial changes, you can easily adapt to the specification changes. But even before Covid, reacting quickly to trends in data has led to the pivot of for instance Viagra from being investigated as a cardiac drug to male impotence.
As for Formedix’ success, Mark cites the willingness to integrate with existing EDC systems and invest in research. Even though metadata repositories are still not recognized as a separate type of solutions, the case for implementing one is clear:
“In 6 trials you have return on investment for your metadata repository and 1,6 million of cost avoidance in regulatory submissions”
Read more:
Guest Mark Wheeldon https://www.linkedin.com/in/markwheeldonformedix/
Formedix https://www.formedix.com/
DIA - https://www.diaglobal.org/
CDISC https://www.cdisc.org/
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