When: December 7, 4 PM GMT / 11 AM EST / 8 AM PST
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.
- F.A.I.R. and Shared Data, Transforming the Ecosystem to drive Insights and Advanced Analytics
- The principal legal and ethical considerations regarding the repurposing of clinical trial data
- Policy-based data access
At the conclusion of this session, participants should be able to:
- Recognize the role of advanced analytics in transforming data sharing
- Consider the pathways afforded to us for the repurposing of (‘the secondary use of’) clinical trial data within the current legal and ethical frameworks for data privacy and confidentiality.
- Evaluate data access through purpose and policy
- Benjamin Szilagyi, MSc, VP, Head Insights Data & Experimental Analytics, Roche
- Francis Crawley, Executive Director, GCP Alliance
- Chris Edwards, Solution Architect, Patient Data, AstraZeneca
Who Should Attend:
- AI / ML / NLP Specialists
- Data Architects
- Clinical R&D Strategist
- Global Medical Affairs professionals
- Patient Engagement and Advocacy Groups
- Healthcare Professionals
- Global Data Privacy professionals
- Data Governance & Medical Governance professionals
- Ethics, Risk & Compliance professionals
- Clinical Quality Assurance professionals
- Global Regulatory Affairs professionals
- Clinical Laboratory Sciences professionals
- Clinical Operations professionals
- Business Excellence & Process Improvement professionals
Ready to Get Involved?
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.