Tuesday, 27 June 2023,  5 PM CEST/ 3PM GMT

About Zahra Karimaddini

Zahra Karimaddini, PhD, has a background in computational biology, data science and personalized medicine. Zahra received her PhD in Computation Biology and Bioinformatics from ETH Zürich, with a focus on applied mathematics in neural development. Later she joined Roche as a postdoctoral researcher with a focus on machine learning in cancer biology. Since 2020 she has worked as Data Standards and Governance Specialist at Roche. In this role she is working on development and enhancement of various nonCRF data models, including digital measures, that collect clinical trial data F.A.I.R.ly and regulatory compliant.

In addition to her work at Roche, Zahra is currently co-leading the Digital Health Technology (DHT) subteam at CDISC to develop data standards for using DHTs in clinical trials.

About the Lecture

Digital Health Technology Tools (DHTs) have been advanced in their usage and capabilities. The ability of remotely, and if needed continuously, collecting data compared to the intermittent trial visits, advances in the analytical methods, enhancement in the processes to increase the patient adherence, and the transparency in the verification and validation of DHTs are paving the way for acceptance of using DHTs in the clinical trials by health authorities. The large data generated by DHTs can greatly vary in their format depending on the DHT type and usage. As a result, there is a need for data standardization through the entire clinical trial data lifecycle to facilitate data F.A.I.R.ification and accelerate regulatory submissions. This lecture will focus on the current state of the health authorities guidelines and recommendations in using DHTs in clinical trials. Later, the workflow of clinical data standardization with a focus on the DHT data generated by various digital health solutions such as wearables, smartphones, applications, patches, etc will be presented. This will include the challenges of DHT data standardization as well as its opportunities.

We are pleased to invite you to join this guest lecture. Registration is not required. Please be aware that we will be recording this guest lecture and will be making it available in our teaching library. If you have any questions, please contact Giuliana Breu (giuliana.breu@unisg.ch) prior to the start of the guest lecture.