Profs. Sarah Zohar & Melissa McCradden (April 21, Friday)
Temerty Special Seminar Series in AI + HEALTHCARE, featuring Prof. Sarah Zohar and Prof. Melissa McCradden
This event is now over and we will post the video as soon as it is available.
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Seminar by Prof. Sarah Zohar
Methodological challenges for clinical evaluation of digital medical devices based on AI algorithms
Health-related interventions and their evaluation have been revolutionized by advances in biotechnology and digitization and expectations are high. To support the acceleration of drug development and other medical interventions through the use of artificial intelligence (AI) and data from a variety of sources, there is a need for a clear understanding of the appropriateness of this use and for robust trial evaluation methods. The need to adapt the methods used and to propose robust innovative approaches to clinical trials is increasingly critical, and for example, the proliferation of new digital medical devices using AI alone requires specific methods to evaluate their ultimate impact on health. In this presentation, the PEPR Digital Health "SMATCH" project will be presented as well as the scientific challenges associated with the clinical evaluation of Digital Medical Devices. In addition, links with the regulatory requirements and EU initiatives will be presented.
Biography: Head of HeKA, Dr. Sarah Zohar is an expert in innovative methods for interventional and observational health data modelling including drug and Digital Medical Devices evaluation. She has made many methodological contributions to exploratory clinical trials and real-life health data analysis proposing novel methods and approaches that have been applied in cancer, rare diseases, resistance to antibiotics and pediatric clinical trials among other fields. She has collaborated with physicians in the designing, planning, conducting and analyzing clinical trials and developed new approaches in collaboration with international methodological experts from USA, Japan, and Europe. She is a member of the French HTA for Medical Device reimbursement commission, that is, CNEDIMTS at HAS (“Haute Autorité de Santé”). She is currently participating at the French HTA, HAS, working group on “Digital medical devices for professional use”. She has participated in a workgroup for the access to innovative drugs at French HTA, this workgroup work was published in BMJ Evidence Based Medicine 2023. (http://dx.doi.org/10.1136/bmjebm-2022-112091). She is part of the European taskforce of EIT Health and the French Ministry of Solidarity and Health for “harmonization of clinical studies criteria & methodologies in Europe for the evaluation of digital medical devices. She has been invited to speak as keynote speaker or contributor at a number of international scientific meetings.
What makes ‘Ethical AI’, anyway? Exploring good evidence and clinical practice for data-driven paediatric care
Artificial intelligence and machine learning-enabled technologies are proliferating in healthcare while the evidentiary foundation for their use remains an open question: what constitutes evidence, how do we collect it, and what is enough evidence? This presentation will discuss the matter of evidence in the context of responsible AI development and how a translation pathway can enable us to collect information to support clinical decision-making and promote patient benefit. Next, I will present the results from a study on ethical decision-making with AI exploring the role of explainability in clinical decision-making. We will discuss how information – including that from AI systems – can be integrated into the established paradigm of shared decision-making to maintain quality care and preserve patients’ rights without a strict requirement of prediction-level explainability.
Biography: Dr. McCradden is a Bioethicist with the Department of Bioethics at The Hospital for Sick Children (SickKids), providing clinical and organization ethics consultations, policy, and education in bioethics. She is the John and Melinda Thompson Director of Artificial Intelligence in Medicine (AIM) where she is the Integration Lead for AIM. Dr. McCradden is also an Associate Scientist with the Genetics and Genome Biology Program at SickKids and an Assistant Professor with the University of Toronto Dalla Lana School of Public Health.
