LABORATORY INFORMATICS


or manufacturing. From a regulator’s perspective, being able to evaluate drug submissions provided in standardised electronic formats not only saves time and money, it makes it possible to review new submissions in the context of previous applications, suggests Kevin Trimm, head of product management for pharmacometrics software at Certara. ‘Each application is still reviewed


community standards and protocols that have already been well tested,’ Harrow noted.


‘What you don’t want to do is make


use of a proprietary solution for standardisation. One of the big strengths of the Fair principles, and how they are implemented, is that they embrace open standards. That doesn’t mean that your data is open. The data itself can still be closed, and locked in to your system. But the standards and the protocols that are used to manage and, where appropriate, communicate that data should be open, and relevant. Examples include AnIML and SILA, and Allotrope Foundation. EMBL’s EBI and NCBO’s bioportal are key sources for ontologies,’ stated Harrow. Companies should consider that


Fair and standardised data go hand-in- hand, whether the underlying science is hypothesis-driven, or data-driven, Harrow suggested. ‘Whatever data lake you are fishing in, the chances are if your data follow Fair principles and are accessible in standardised formats, then the depth and breadth of insight will increase, both for your current studies and when you come to reuse the data, possibly years down the line. You want to be able to spend more


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”There has to be a balance between pragmatism and forward thinking. Where does it make sense to make your data Fair?”


time analysing that data and deriving utility from it, rather than wrangling the data to make it Fair after the event.’ The Pistoia Alliance Fair toolkit is being funded by some of the global pharma players, including Roche, AstraZenea, Abbvie, BMS and Novartis. ‘Over the next few months we aim to


bring content that we’ve been developing and gathering into the web page templates, with the aim of launching early next year,’ Harrow said. ‘It’s a collective initiative, and a great


example of pre-competitive development. There has been input from a good, healthy mix of consumers of data, data content providers, and technology vendors. That’s a healthy mix.’ The benefits of standardising data


formats extends to regulators, as well as to the companies and academic organisations that are carrying out R&D


on its own merits, but an extra layer of perspective and insight is now possible, because reviewers can contrast and compare study data – both clinical and preclinical – that support an application, by calling up data on prior studies of a similar type, such as those that evaluated the same class of molecules, or were testing drugs for the same disease indication,’ said Trimm. For any drug regulator, building databases of key submission data and metadata from each study in an application is prohibitively labour intensive. What makes much more sense is to request that all applications are accompanied by data and metadata in standardised electronic formats, which can then automatically populate such databases, and provide equivalence in future review. FDA reviewers can then call up or mine historical data for comparison during their assessment of new applications.


Building common data standards It was this need to set up standardisation for electronic drug submissions that led to the creation of the Clinical Data Interchange Standards Consortium (CDISC), a standards development organisation that is building common data standards for supporting electronic regulatory submissions. The organisation has developed multiple standards covering regulatory submission types, disease fields and therapeutic areas. Each standard is designed to facilitate the accessibility, interoperability and reusability of clinical research and research data – think Fair principles – whatever its source. Pioneered by FDA, CDISC is now a global, non-profit community initiative, funded by more than 450 member organisations, as well as through grants, events and educational initiatives. The organisation itself states that


CDISC standards have been adopted and implemented in over 90 countries. CDISC standard formats are now required for electronic submissions to FDA in the US, and to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan. CDISC standards were also endorsed


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