This workshop was needed to evaluate the 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 that brought together industry, academic and regulatory partners presents a unique opportunity to explore these issues.
At this multi-stakeholder workshop, meeting delegates had 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 2-days meeting consisted of 5 plenary sessions and adequate discussion and networking time. Each session also included various perspectives of academics, HTAs, regulatory agencies, patient advocates and industry and discussed challenges related to digital tools.
From this interactive workshop, participants achieved 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 was a multidisciplinary audience of academia representatives, EU and US regulatory bodies (EMA, FDA, National Agencies), pharmaceutical Industry, HTAs and patient advocates.