Enhancing Access to Clinical Trial Data for Secondary Use
While the life sciences R&D industry is re-imagining clinical trial design in the age of digitalization, historical clinical trial data remains an important source of evidence that could inform today’s drug discovery and development.
In many pharma companies, it takes considerable time for an internal business function, such as research, to gain access to the company’s historical clinical data assets. Specifically, secondary use of clinical trial data needs approval by the appropriate internal governance function (legal/compliance/medical). Inter alia, this approval is granted upon verifying that the informed consent form (signed by the patient involved in the clinical trial) provides permission for the company to access the data for secondary use.
Furthermore, in a global clinical trial, patients will be recruited from many different nation-states, with their different languages, and each nation-state will have a national competent agency (regulatory agency) which may have a view on the eligibility of the secondary use of the data from that clinical trial.
At the Pistoia Alliance, we are exploring how the FAIRification of such data, along with advanced analytics including AL/ML/NLP powered systems can be used to access/share/reuse patient data from historical clinical trials. All this takes into account any applicable regulations and legislation.
In this talk, our presenters will highlight the key aspects to be considered in our path towards finding a common solution to this common problem.
At the conclusion of this session, participants should be able to:
There has never been a more important time to collaborate to innovate as an industry! If you would like to find out more about the benefits of Pistoia Alliance membership and how you can get involved with all the different initiatives we run, please send an email to Membership@PistoiaAlliance.org.
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