This workshop is needed to evaluate the current state of play in terms of opportunity and regulatory perspectives as increasing numbers of digital tools are being incorporated into clinical trials. This is bringing challenges in terms of validation of endpoints, interpretation of data and also data security – a CDDF workshop bringing together industry, academic and regulatory partners presents a unique opportunity to explore these issues.
At this multi-stakeholder workshop, meeting delegates will have the opportunity to discuss the use of digital tools and AI in cancer drug development, covering digital tools, digital diagnosis and AI within clinical trials. The 1.5-day meeting consists of 4 plenary sessions and adequate discussion and networking time. Each session will also include various perspectives of academics, HTAs, regulatory agencies, patient advocates and industry and discuss challenges of digital tools.
From this interactive workshop, participants will achieve the following outcomes:
- To understand the current landscape of use to digital tools in cancer drug development
- To explore regulatory aspects, challenges and plans for formal registration of digital tools from trial data
- To learn about the various digital options to support trials and improve data collection and outcomes
The target is a multidisciplinary audience of academia representatives, EU and US regulatory bodies (EMA, FDA, National Agencies), pharmaceutical Industry, HTAs and patient advocates.